29 results on '"van Westreenen, H. L."'
Search Results
2. Upfront resection versus no resection of the primary tumor in patients with synchronous metastatic colorectal cancer:the randomized phase III CAIRO4 study conducted by the Dutch Colorectal Cancer Group and the Danish Colorectal Cancer Group
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van der Kruijssen, D. E.W., Elias, S. G., van de Ven, P. M., van Rooijen, K. L., Lam-Boer, J. ’t, Mol, L., Punt, C. J.A., Sommeijer, D. W., Tanis, P. J., Nielsen, J. D., Yilmaz, M. K., van Riel, J. M.G.H., Wasowiz-Kemps, D. K., Loosveld, O. J.L., van der Schelling, G. P., de Groot, J. W.B., van Westreenen, H. L., Jakobsen, H. L., Fromm, A. L., Hamberg, P., Verseveld, M., Jaensch, C., Liposits, G. I., van Duijvendijk, P., Oulad Hadj, J., van der Hoeven, J. A.B., Trajkovic, M., de Wilt, J. H.W., Koopman, M., van der Kruijssen, D. E.W., Elias, S. G., van de Ven, P. M., van Rooijen, K. L., Lam-Boer, J. ’t, Mol, L., Punt, C. J.A., Sommeijer, D. W., Tanis, P. J., Nielsen, J. D., Yilmaz, M. K., van Riel, J. M.G.H., Wasowiz-Kemps, D. K., Loosveld, O. J.L., van der Schelling, G. P., de Groot, J. W.B., van Westreenen, H. L., Jakobsen, H. L., Fromm, A. L., Hamberg, P., Verseveld, M., Jaensch, C., Liposits, G. I., van Duijvendijk, P., Oulad Hadj, J., van der Hoeven, J. A.B., Trajkovic, M., de Wilt, J. H.W., and Koopman, M.
- Abstract
Background: Upfront primary tumor resection (PTR) has been associated with longer overall survival (OS) in patients with synchronous unresectable metastatic colorectal cancer (mCRC) in retrospective analyses. The aim of the CAIRO4 study was to investigate whether the addition of upfront PTR to systemic therapy resulted in a survival benefit in patients with synchronous mCRC without severe symptoms of their primary tumor. Patients and methods: This randomized phase III trial was conducted in 45 hospitals in The Netherlands and Denmark. Eligibility criteria included previously untreated mCRC, unresectable metastases, and no severe symptoms of the primary tumor. Patients were randomized (1 : 1) to upfront PTR followed by systemic therapy or systemic therapy without upfront PTR. Systemic therapy consisted of first-line fluoropyrimidine-based chemotherapy with bevacizumab in both arms. Primary endpoint was OS in the intention-to-treat population. The study was registered at ClinicalTrials.gov, NCT01606098. Results: Between August 2012 and February 2021, 206 patients were randomized. In the intention-to-treat analysis, 204 patients were included (n = 103 without upfront PTR, n = 101 with upfront PTR) of whom 116 were men (57%) with median age of 65 years (interquartile range 59-71 years). Median follow-up was 69.4 months. Median OS in the arm without upfront PTR was 18.3 months (95% confidence interval 16.0-22.2 months) compared with 20.1 months (95% confidence interval 17.0-25.1 months) in the upfront PTR arm (P = 0.32). The number of grade 3-4 events was 71 (72%) in the arm without upfront PTR and 61 (65%) in the upfront PTR arm (P = 0.33). Three deaths (3%) possibly related to treatment were reported in the arm without upfront PTR and four (4%) in the upfront PTR arm. Conclusions: Addition of upfront PTR to palliative systemic therapy in patients with synchronous mCRC without severe symptom
- Published
- 2024
3. Five-Year Follow-Up of a Slowly Resorbable Biosynthetic P4HB Mesh (Phasix) in VHWG Grade 3 Incisional Hernia Repair
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Van den Dop, L M, Van Rooijen, M M J, Tollens, T, Jørgensen, L N, De Vries-Reilingh, T S, Piessen, G, Köckerling, F, Miserez, M, Dean, M, Berrevoet, F, Dousset, B, Van Westreenen, H L, Gossetti, F, Tetteroo, G W M, Koch, A, Boomsma, M F, Lange, J F, Jeekel, J, Van den Dop, L M, Van Rooijen, M M J, Tollens, T, Jørgensen, L N, De Vries-Reilingh, T S, Piessen, G, Köckerling, F, Miserez, M, Dean, M, Berrevoet, F, Dousset, B, Van Westreenen, H L, Gossetti, F, Tetteroo, G W M, Koch, A, Boomsma, M F, Lange, J F, and Jeekel, J
- Abstract
OBJECTIVE: To assess the 5-year recurrence rate of incisional hernia repair in Ventral Hernia Working Group (VHWG) 3 hernia with a slowly resorbable mesh.SUMMARY BACKGROUND DATA: Incisional hernia recurs frequently after initial repair. In potentially contaminated hernia, recurrences rise to 40%. Recently, the biosynthetic Phasix mesh has been developed that is resorbed in 12-18 months. Resorbable meshes might be a solution for incisional hernia repair to decrease short- and long-term (mesh) complications. However, long-term outcomes after resorption are scarce.METHODS: Patients with VHWG grade 3 incisional midline hernia, who participated in the Phasix trial (Clinilcaltrials.gov: NCT02720042) were included by means of physical examination and computed tomography (CT). Primary outcome was hernia recurrence; secondary outcomes comprised of long-term mesh complications, reoperations, and abdominal wall pain [visual analogue score (VAS): 0-10].RESULTS: In total, 61/84 (72.6%) patients were seen. Median follow-up time was 60.0 [interquartile range (IQR): 55-64] months. CT scan was made in 39 patients (68.4%). A recurrence rate of 15.9% (95% confidence interval: 6.9-24.8) was calculated after 5 years. Four new recurrences (6.6%) were found between 2 and 5 years. Two were asymptomatic. In total, 13/84 recurrences were found. No long-term mesh complications and/or interventions occurred. VAS scores were 0 (IQR: 0-2).CONCLUSIONS: Hernia repair with Phasix mesh in high-risk patients (VHWG 3, body mass index >28) demonstrated a recurrence rate of 15.9%, low pain scores, no mesh-related complications or reoperations for chronic pain between the 2- and 5-year follow-up. Four new recurrences occurred, 2 were asymptomatic. The poly-4-hydroxybutyrate mesh is a safe mesh for hernia repair in VHWG 3 patients, which avoids long-term mesh complications like pain and mesh infection.
- Published
- 2023
4. Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients
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Greijdanus, N, Wienholts, K, Ubels, S, Talboom, K, Hannink, G, Wolthuis, A, de Lacy, F, Lefevre, J, Solomon, M, Frasson, M, Rotholtz, N, Denost, Q, Perez, R, Konishi, T, Panis, Y, Rutegard, M, Hompes, R, Rosman, C, van Workum, F, Tanis, P, de Wilt, J, Bremers, A, Ferenschild, F, de Vriendt, S, D'Hoore, A, Bislenghi, G, Farguell, J, Lacy, A, Atienza, P, van Kessel, C, Parc, Y, Voron, T, Collard, M, Muriel, J, Cholewa, H, Mattioni, L, Frontali, A, Polle, S, Polat, F, Obihara, N, Vailati, B, Kusters, M, Tuynmann, J, Hazen, S, Gruter, A, Amano, T, Fujiwara, H, Salomon, M, Ruiz, H, Gonzalez, R, Estefania, D, Avellaneda, N, Carrie, A, Santillan, M, Pachajoa, D, Parodi, M, Gielis, M, Binder, A, Gurtler, T, Riedl, P, Badiani, S, Berney, C, Morgan, M, Hollington, P, da Silva, N, Nair, G, Ho, Y, Lamparelli, M, Kapadia, R, Kroon, H, Dudi-Venkata, N, Liu, J, Sammour, T, Flamey, N, Pattyn, P, Chaoui, A, Vansteenbrugge, L, van den Broek, N, Vanclooster, P, de Gheldere, C, Pletinckx, P, Defoort, B, Dewulf, M, Slavchev, M, Belev, N, Atanasov, B, Krastev, P, Sokolov, M, Maslyankov, S, Gribnev, P, Pavlov, V, Ivanov, T, Karamanliev, M, Filipov, E, Tonchev, P, Aigner, F, Mitteregger, M, Allmer, C, Seitinger, G, Colucci, N, Buchs, N, Ris, F, Toso, C, Gialamas, E, Vuagniaux, A, Chautems, R, Sauvain, M, Daester, S, von Flue, M, Guenin, M, Taha-Mehlitz, S, Hess, G, Martinek, L, Skrovina, M, Machackova, M, Bencurik, V, Uluk, D, Pratschke, J, Dittrich, L, Guel-Klein, S, Perez, D, Grass, J, Melling, N, Mueller, S, Iversen, L, Eriksen, J, Baatrup, G, Al-Najami, I, Bjorsum-Meyer, T, Teras, J, Teras, R, Monib, F, Ahmed, N, Alkady, E, Ali, A, Khedr, G, Abdelaal, A, Ashoush, F, Ewedah, M, Elshennawy, E, Hussein, M, Fernandez-Martinez, D, Garcia-Florez, L, Fernandez-Hevia, M, Suarez-Sanchez, A, Aretxabala, I, Docampo, I, Zabala, J, Tejedor, P, Morales Bernaldo de Quiros, J, Quiroga, I, Navarro-Sanchez, A, Darias, I, Fernandez, C, de La Cruz Cuadrado, C, Sanchez-Guillen, L, Lopez-Rodriguez-Arias, F, Soler-Silva, A, Arroyo, A, Bernal-Sprekelsen, J, Gomez-Abril, S, Gonzalvez, P, Torres, M, Sanchez, T, Antona, F, Lara, J, Montero, J, Mendoza-Moreno, F, Diez-Alonso, M, Matias-Garcia, B, Quiroga-Valcarcel, A, Colas-Ruiz, E, Tasende-Presedo, M, Fernandez-Hurtado, I, Cifuentes-Rodenas, J, Suarez, M, Losada, M, Hernandez, M, Alonso, A, Dieguez, B, Serralta, D, Quintana, R, Lopez, J, Pinto, F, Nieto-Moreno, E, Bonito, A, Santacruz, C, Marcos, E, Septiem, J, Calero-Lillo, A, Alanez-Saavedra, J, Munoz-Collado, S, Lopez-Lara, M, Martinez, M, Herrero, E, Borda, F, Villar, O, Escartin, J, Blas, J, Ferrer, R, Egea, J, Rodriguez-Infante, A, Minguez-Ruiz, G, Carreno-Villarreal, G, Pire-Abaitua, G, Dziakova, J, Rodriguez, C, Aranda, M, Huguet, J, Borda-Arrizabalaga, N, Enriquez-Navascues, J, Echaniz, G, Ansorena, Y, Estaire-Gomez, M, Martinez-Pinedo, C, Barbero-Valenzuela, A, Ruiz-Garcia, P, Kraft, M, Gomez-Jurado, M, Pellino, G, Espin-Basany, E, Cotte, E, Panel, N, Goutard, C, de Angelis, N, Lauka, L, Shaikh, S, Osborne, L, Ramsay, G, Nichita, V, Bhandari, S, Sarmah, P, Bethune, R, Pringle, H, Massey, L, Fowler, G, Hamid, H, de Simone, B, Kynaston, J, Bradley, N, Stienstra, R, Gurjar, S, Mukherjee, T, Chandio, A, Ahmed, S, Singh, B, Runau, F, Chaudhri, S, Siaw, O, Sarveswaran, J, Miu, V, Ashmore, D, Darwich, H, Singh-Ranger, D, Singh, N, Shaban, M, Gareb, F, Petropolou, T, Polydorou, A, Dattani, M, Afzal, A, Bavikatte, A, Sebastian, B, Ward, N, Mishra, A, Manatakis, D, Agalianos, C, Tasis, N, Antonopoulou, M, Karavokyros, I, Charalabopoulos, A, Schizas, D, Baili, E, Syllaios, A, Karydakis, L, Vailas, M, Balalis, D, Korkolis, D, Plastiras, A, Rompou, A, Xenaki, S, Xynos, E, Chrysos, E, Venianaki, M, Christodoulidis, G, Perivoliotis, K, Tzovaras, G, Baloyiannis, I, Ho, M, Ng, S, Mak, T, Futaba, K, Santak, G, Simlesa, D, Cosic, J, Zukanovic, G, Kelly, M, Larkin, J, Mccormick, P, Mehigan, B, Connelly, T, Neary, P, Ryan, J, Mccullough, P, Al-Juaifari, M, Hammoodi, H, Abbood, A, Calabro, M, Muratore, A, La Terra, A, Farnesi, F, Feo, C, Fabbri, N, Pesce, A, Fazzin, M, Roscio, F, Clerici, F, Lucchi, A, Vittori, L, Agostinelli, L, Ripoli, M, Sambucci, D, Porta, A, Sinibaldi, G, Crescentini, G, Larcinese, A, Picone, E, Persiani, R, Biondi, A, Pezzuto, R, Lorenzon, L, Rizzo, G, Coco, C, D'Agostino, L, Spinelli, A, Sacchi, M, Carvello, M, Foppa, C, Maroli, A, Palini, G, Garulli, G, Zanini, N, Delrio, P, Rega, D, Carbone, F, Aversano, A, Pirozzolo, G, Recordare, A, D'Alimonte, L, Vignotto, C, Corbellini, C, Sampietro, G, Lorusso, L, Manzo, C, Ghignone, F, Ugolini, G, Montroni, I, Pasini, F, Ballabio, M, Bisagni, P, Armao, F, Longhi, M, Ghazouani, O, Galleano, R, Tamini, N, Oldani, M, Nespoli, L, Picciariello, A, Altomare, D, Tomasicchio, G, Lantone, G, Catena, F, Giuffrida, M, Annicchiarico, A, Perrone, G, Grossi, U, Santoro, G, Zanus, G, Iacomino, A, Novello, S, Passuello, N, Zucchella, M, Puca, L, Degiuli, M, Reddavid, R, Scabini, S, Aprile, A, Soriero, D, Fioravanti, E, Rottoli, M, Romano, A, Tanzanu, M, Belvedere, A, Mariani, N, Ceretti, A, Opocher, E, Gallo, G, Sammarco, G, de Paola, G, Pucciarelli, S, Marchegiani, F, Spolverato, G, Buzzi, G, Di Saverio, S, Meroni, P, Parise, C, Bottazzoli, E, Lapolla, P, Brachini, G, Cirillo, B, Mingoli, A, Sica, G, Siragusa, L, Bellato, V, Cerbo, D, de Pasqual, C, de Manzoni, G, di Cosmo, M, Alrayes, B, Qandeel, M, Hani, M, Rabadi, A, el Muhtaseb, M, Abdeen, B, Karmi, F, Zilinskas, J, Latkauskas, T, Tamelis, A, Pikuniene, I, Slenfuktas, V, Poskus, T, Kryzauskas, M, Jakubauskas, M, Mikalauskas, S, Jakubauskiene, L, Hassan, S, Altrabulsi, A, Abdulwahed, E, Ghmagh, R, Deeknah, A, Alshareea, E, Elhadi, M, Abujamra, S, Msherghi, A, Tababa, O, Majbar, M, Souadka, A, Benkabbou, A, Mohsine, R, Echiguer, S, Moctezuma-Velazquez, P, Salgado-Nesme, N, Vergara-Fernandez, O, Sainz-Hernandez, J, Alvarez-Bautista, F, Zakaria, A, Zakaria, Z, Wong, M, Ismail, R, Ibrahim, A, Abdullah, N, Julaihi, R, Bhat, S, O'Grady, G, Bissett, I, Lamme, B, Musters, G, Dinaux, A, Grotenhuis, B, Steller, E, Aalbers, A, Leeuwenburgh, M, Rutten, H, Burger, J, Bloemen, J, Ketelaers, S, Waqar, U, Chawla, T, Rauf, H, Rani, P, Talsma, A, Scheurink, L, van Praagh, J, Segelman, J, Nygren, J, Anderin, K, Tiefenthal, M, de Andres, B, Beltran de Heredia, J, Vazquez, A, Gomez, T, Golshani, P, Kader, R, Mohamed, A, Westerterp, M, Marinelli, A, Niemer, Q, Doornebosch, P, Shapiro, J, Vermaas, M, de Graaf, E, van Westreenen, H, Zwakman, M, van Dalsen, A, Vles, W, Nonner, J, Toorenvliet, B, Janssen, P, Verdaasdonk, E, Amelung, F, Peeters, K, Bahadoer, R, Holman, F, Heemskerk, J, Vosbeek, N, Leijtens, J, Taverne, S, Heijnen, B, El-Massoudi, Y, de Groot-Van Veen, I, Hoff, C, Jou-Valencia, D, Consten, E, Burghgraef, T, Geitenbeek, R, Hulshof, L, Slooter, G, Reudink, M, Bouvy, N, Wildeboer, A, Verstappen, S, Pennings, A, van den Hengel, B, Wijma, A, de Haan, J, de Nes, L, Heesink, V, Karsten, T, Heidsma, C, Koemans, W, Dekker, J, van der Zijden, C, Roos, D, Demirkiran, A, van der Burg, S, Oosterling, S, Hoogteijling, T, Wiering, B, Smeeing, D, Havenga, K, Lutfi, H, Tsimogiannis, K, Skoldberg, F, Folkesson, J, den Boer, F, van Schaik, T, van Gerven, P, Sietses, C, Hol, J, Boerma, E, Creemers, D, Schultz, J, Frivold, T, Riis, R, Gregussen, H, Busund, S, Sjo, O, Gaard, M, Krohn, N, Ersryd, A, Leung, E, Sultan, H, Hajjaj, B, Alhisi, A, Khader, A, Mendes, A, Semiao, M, Faria, L, Azevedo, C, da Costa Devesa, H, Martins, S, Jarimba, A, Marques, S, Ferreira, R, Oliveira, A, Ferreira, C, Pereira, R, Surlin, V, Graure, G, Ramboiu, S, Negoi, I, Ciubotaru, C, Stoica, B, Tanase, I, Negoita, V, Florea, S, Macau, F, Vasile, M, Stefanescu, V, Dimofte, G, Lunca, S, Roata, C, Musina, A, Garmanova, T, Agapov, M, Markaryan, D, Eduard, G, Yanishev, A, Abelevich, A, Bazaev, A, Rodimov, S, Filimonov, V, Melnikov, A, Suchkov, I, Drozdov, E, Kostromitskiy, D, Sjostrom, O, Matthiessen, P, Baban, B, Gadan, S, Jadid, K, Staffan, M, Park, J, Rydbeck, D, Lydrup, M, Buchwald, P, Jutesten, H, Darlin, L, Lindqvist, E, Nilsson, K, Larsson, P, Jangmalm, S, Kosir, J, Tomazic, A, Grosek, J, Bozic, T, Zazo, A, Zazo, R, Fares, H, Ayoub, K, Niazi, A, Mansour, A, Abbas, A, Tantoura, M, Hamdan, A, Hassan, N, Hasan, B, Saad, A, Sebai, A, Haddad, A, Maghrebi, H, Kacem, M, Yalkin, O, Samsa, M, Atak, I, Balci, B, Haberal, E, Dogan, L, Gecim, I, Akyol, C, Koc, M, Sivrikoz, E, Piyadeoglu, D, Avanagh, D, Sokmen, S, Bisgin, T, Gunenc, E, Guzel, M, Leventoglu, S, Yuksel, O, Kozan, R, Gobut, H, Cengiz, F, Erdinc, K, Acar, N, Kamer, E, Ozgur, I, Aydin, O, Keskin, M, Bulut, M, Kulle, C, Kara, Y, Sibic, O, Ozata, I, Bugra, D, Balik, E, Cakir, M, Alhardan, A, Colak, E, Aybar, A, Sari, A, Atici, S, Kaya, T, Dursun, A, Calik, B, Ozkan, O, Ulgur, H, Duzgun, O, Monson, J, George, S, Woods, K, Al-Eryani, F, Albakry, R, Coetzee, E, Boutall, A, Herman, A, Warden, C, Mugla, N, Forgan, T, Mia, I, Lambrechts, A, Greijdanus N. G., Wienholts K., Ubels S., Talboom K., Hannink G., Wolthuis A., de Lacy F. B., Lefevre J. H., Solomon M., Frasson M., Rotholtz N., Denost Q., Perez R. O., Konishi T., Panis Y., Rutegard M., Hompes R., Rosman C., van Workum F., Tanis P. J., de Wilt J. H. W., Bremers A. J. A., Ferenschild F. T., de Vriendt S., D'Hoore A., Bislenghi G., Farguell J., Lacy A. M., Atienza P. G., van Kessel C. S., Parc Y., Voron T., Collard M. K., Muriel J. S., Cholewa H., Mattioni L. A., Frontali A., Polle S. W., Polat F., Obihara N. J., Vailati B. B., Kusters M., Tuynmann J. B., Hazen S. J. A., Gruter A. A. J., Amano T., Fujiwara H., Salomon M., Ruiz H., Gonzalez R., Estefania D., Avellaneda N., Carrie A., Santillan M., Pachajoa D. A. P., Parodi M., Gielis M., Binder A. -D., Gurtler T., Riedl P., Badiani S., Berney C., Morgan M., Hollington P., da Silva N., Nair G., Ho Y. M., Lamparelli M., Kapadia R., Kroon H. M., Dudi-Venkata N. N., Liu J., Sammour T., Flamey N., Pattyn P., Chaoui A., Vansteenbrugge L., van den Broek N. E. J., Vanclooster P., de Gheldere C., Pletinckx P., Defoort B., Dewulf M., Slavchev M., Belev N., Atanasov B., Krastev P., Sokolov M., Maslyankov S., Gribnev P., Pavlov V., Ivanov T., Karamanliev M., Filipov E., Tonchev P., Aigner F., Mitteregger M., Allmer C., Seitinger G., Colucci N., Buchs N., Ris F., Toso C., Gialamas E., Vuagniaux A., Chautems R., Sauvain M. -O., Daester S., von Flue M., Guenin M. -O., Taha-Mehlitz S., Hess G. F., Martinek L., Skrovina M., Machackova M., Bencurik V., Uluk D., Pratschke J., Dittrich L. S., Guel-Klein S., Perez D., Grass J. -K., Melling N., Mueller S., Iversen L. H., Eriksen J. D., Baatrup G., Al-Najami I., Bjorsum-Meyer T., Teras J., Teras R. M., Monib F. A., Ahmed N. E. A. E., Alkady E., Ali A. K., Khedr G. A. E., Abdelaal A. S., Ashoush F. M. B., Ewedah M., Elshennawy E. M., Hussein M., Fernandez-Martinez D., Garcia-Florez L. J., Fernandez-Hevia M., Suarez-Sanchez A., Aretxabala I. D. H., Docampo I. L., Zabala J. G., Tejedor P., Morales Bernaldo de Quiros J. T., Quiroga I. B., Navarro-Sanchez A., Darias I. S., Fernandez C. L., de La Cruz Cuadrado C., Sanchez-Guillen L., Lopez-Rodriguez-Arias F., Soler-Silva A., Arroyo A., Bernal-Sprekelsen J. C., Gomez-Abril S. A., Gonzalvez P., Torres M. T., Sanchez T. R., Antona F. B., Lara J. E. S., Montero J. A. A., Mendoza-Moreno F., Diez-Alonso M., Matias-Garcia B., Quiroga-Valcarcel A., Colas-Ruiz E., Tasende-Presedo M. M., Fernandez-Hurtado I., Cifuentes-Rodenas J. A., Suarez M. C., Losada M., Hernandez M., Alonso A., Dieguez B., Serralta D., Quintana R. E. M., Lopez J. M. G., Pinto F. L., Nieto-Moreno E., Bonito A. C., Santacruz C. C., Marcos E. B., Septiem J. G., Calero-Lillo A., Alanez-Saavedra J., Munoz-Collado S., Lopez-Lara M., Martinez M. L., Herrero E. F., Borda F. J. G., Villar O. G., Escartin J., Blas J. L., Ferrer R., Egea J. G., Rodriguez-Infante A., Minguez-Ruiz G., Carreno-Villarreal G., Pire-Abaitua G., Dziakova J., Rodriguez C. S. -C., Aranda M. J. P., Huguet J. M. M., Borda-Arrizabalaga N., Enriquez-Navascues J. M., Echaniz G. E., Ansorena Y. S., Estaire-Gomez M., Martinez-Pinedo C., Barbero-Valenzuela A., Ruiz-Garcia P., Kraft M., Gomez-Jurado M. J., Pellino G., Espin-Basany E., Cotte E., Panel N., Goutard C. -A., de Angelis N., Lauka L., Shaikh S., Osborne L., Ramsay G., Nichita V. -I., Bhandari S., Sarmah P., Bethune R. M., Pringle H. C. M., Massey L., Fowler G. E., Hamid H. K. S., de Simone B. D., Kynaston J., Bradley N., Stienstra R. M., Gurjar S., Mukherjee T., Chandio A., Ahmed S., Singh B., Runau F., Chaudhri S., Siaw O., Sarveswaran J., Miu V., Ashmore D., Darwich H., Singh-Ranger D., Singh N., Shaban M., Gareb F., Petropolou T., Polydorou A., Dattani M., Afzal A., Bavikatte A., Sebastian B., Ward N., Mishra A., Manatakis D., Agalianos C., Tasis N., Antonopoulou M. -I., Karavokyros I., Charalabopoulos A., Schizas D., Baili E., Syllaios A., Karydakis L., Vailas M., Balalis D., Korkolis D., Plastiras A., Rompou A., Xenaki S., Xynos E., Chrysos E., Venianaki M., Christodoulidis G., Perivoliotis K., Tzovaras G., Baloyiannis I., Ho M. -F., Ng S. S., Mak T. W. -C., Futaba K., Santak G., Simlesa D., Cosic J., Zukanovic G., Kelly M. E., Larkin J. O., McCormick P. H., Mehigan B. J., Connelly T. M., Neary P., Ryan J., McCullough P., Al-Juaifari M. A., Hammoodi H., Abbood A. H., Calabro M., Muratore A., La Terra A., Farnesi F., Feo C. V., Fabbri N., Pesce A., Fazzin M., Roscio F., Clerici F., Lucchi A., Vittori L., Agostinelli L., Ripoli M. C., Sambucci D., Porta A., Sinibaldi G., Crescentini G., Larcinese A., Picone E., Persiani R., Biondi A., Pezzuto R., Lorenzon L., Rizzo G., Coco C., D'Agostino L., Spinelli A., Sacchi M. M., Carvello M., Foppa C., Maroli A., Palini G. M., Garulli G., Zanini N., Delrio P., Rega D., Carbone F., Aversano A., Pirozzolo G., Recordare A., D'Alimonte L., Vignotto C., Corbellini C., Sampietro G. M., Lorusso L., Manzo C. A., Ghignone F., Ugolini G., Montroni I., Pasini F., Ballabio M., Bisagni P., Armao F. T., Longhi M., Ghazouani O., Galleano R., Tamini N., Oldani M., Nespoli L., Picciariello A., Altomare D. F., Tomasicchio G., Lantone G., Catena F., Giuffrida M., Annicchiarico A., Perrone G., Grossi U., Santoro G. A., Zanus G., Iacomino A., Novello S., Passuello N., Zucchella M., Puca L., deGiuli M., Reddavid R., Scabini S., Aprile A., Soriero D., Fioravanti E., Rottoli M., Romano A., Tanzanu M., Belvedere A., Mariani N. M., Ceretti A. P., Opocher E., Gallo G., Sammarco G., de Paola G., Pucciarelli S., Marchegiani F., Spolverato G., Buzzi G., Di Saverio S., Meroni P., Parise C., Bottazzoli E. I., Lapolla P., Brachini G., Cirillo B., Mingoli A., Sica G., Siragusa L., Bellato V., Cerbo D., de Pasqual C. A., de Manzoni G., di Cosmo M. A., Alrayes B. M. H., Qandeel M. W. M., Hani M. B., Rabadi A., el Muhtaseb M. S., Abdeen B., Karmi F., Zilinskas J., Latkauskas T., Tamelis A., Pikuniene I., Slenfuktas V., Poskus T., Kryzauskas M., Jakubauskas M., Mikalauskas S., Jakubauskiene L., Hassan S. Y., Altrabulsi A., Abdulwahed E., Ghmagh R., Deeknah A., Alshareea E., Elhadi M., Abujamra S., Msherghi A. A., Tababa O. W. E., Majbar M. A., Souadka A., Benkabbou A., Mohsine R., Echiguer S., Moctezuma-Velazquez P., Salgado-Nesme N., Vergara-Fernandez O., Sainz-Hernandez J. C., Alvarez-Bautista F. E., Zakaria A. D., Zakaria Z., Wong M. P. K., Ismail R., Ibrahim A. F., Abdullah N. A. N., Julaihi R., Bhat S., O'Grady G., Bissett I., Lamme B., Musters G. D., Dinaux A. M., Grotenhuis B. A., Steller E. J., Aalbers A. G. J., Leeuwenburgh M. M., Rutten H. J. T., Burger J. W. A., Bloemen J. G., Ketelaers S. H. J., Waqar U., Chawla T., Rauf H., Rani P., Talsma A. K., Scheurink L., van Praagh J. B., Segelman J., Nygren J., Anderin K., Tiefenthal M., de Andres B., Beltran de Heredia J. P., Vazquez A., Gomez T., Golshani P., Kader R., Mohamed A., Westerterp M., Marinelli A., Niemer Q., Doornebosch P. G., Shapiro J., Vermaas M., de Graaf E. J. R., van Westreenen H. L., Zwakman M., van Dalsen A. D., Vles W. J., Nonner J., Toorenvliet B. R., Janssen P. T. J., Verdaasdonk E. G. G., Amelung F. J., Peeters K. C. M. J., Bahadoer R. R., Holman F. A., Heemskerk J., Vosbeek N., Leijtens J. W. A., Taverne S. B. M., Heijnen B. H. M., El-Massoudi Y., de Groot-Van Veen I., Hoff C., Jou-Valencia D., Consten E. C. J., Burghgraef T. A., Geitenbeek R., Hulshof L. G. W. L., Slooter G. D., Reudink M., Bouvy N. D., Wildeboer A. C. L., Verstappen S., Pennings A. J., van den Hengel B., Wijma A. G., de Haan J., de Nes L. C. F., Heesink V., Karsten T., Heidsma C. M., Koemans W. J., Dekker J. -W. T., van der Zijden C. J., Roos D., Demirkiran A., van der Burg S., Oosterling S. J., Hoogteijling T. J., Wiering B., Smeeing D. P. J., Havenga K., Lutfi H., Tsimogiannis K., Skoldberg F., Folkesson J., den Boer F., van Schaik T. G., van Gerven P., Sietses C., Hol J. C., Boerma E. -J. G., Creemers D. M. J., Schultz J. K., Frivold T., Riis R., Gregussen H., Busund S., Sjo O. H., Gaard M., Krohn N., Ersryd A. L., Leung E., Sultan H., Hajjaj B. N., Alhisi A. J., Khader A. A. E., Mendes A. F. D., Semiao M., Faria L. Q., Azevedo C., da Costa Devesa H. M., Martins S. F., Jarimba A. M. R., Marques S. M. R., Ferreira R. M., Oliveira A., Ferreira C., Pereira R., Surlin V. M., Graure G. M., Ramboiu S. P. S. D., Negoi I., Ciubotaru C., Stoica B., Tanase I., Negoita V. M., Florea S., Macau F., Vasile M., Stefanescu V., Dimofte G. -M., Lunca S., Roata C. -E., Musina A. -M., Garmanova T., Agapov M. N., Markaryan D. G., Eduard G., Yanishev A., Abelevich A., Bazaev A., Rodimov S. V., Filimonov V. B., Melnikov A. A., Suchkov I. A., Drozdov E. S., Kostromitskiy D. N., Sjostrom O., Matthiessen P., Baban B., Gadan S., Jadid K. D., Staffan M., Park J. M., Rydbeck D., Lydrup M. -L., Buchwald P., Jutesten H., Darlin L., Lindqvist E., Nilsson K., Larsson P. -A., Jangmalm S., Kosir J. A., Tomazic A., Grosek J., Bozic T. K., Zazo A., Zazo R., Fares H., Ayoub K., Niazi A., Mansour A., Abbas A., Tantoura M., Hamdan A., Hassan N., Hasan B., Saad A., Sebai A., Haddad A., Maghrebi H., Kacem M., Yalkin O., Samsa M. V., Atak I., Balci B., Haberal E., Dogan L., Gecim I. E., Akyol C., Koc M. A., Sivrikoz E., Piyadeoglu D., Avanagh D. O., Sokmen S., Bisgin T., Gunenc E., Guzel M., Leventoglu S., Yuksel O., Kozan R., Gobut H., Cengiz F., Erdinc K., Acar N. C., Kamer E., Ozgur I., Aydin O., Keskin M., Bulut M. T., Kulle C. B., Kara Y., Sibic O., Ozata I. H., Bugra D., Balik E., Cakir M., Alhardan A., Colak E., Aybar A. B. C., Sari A. C., Atici S. D., Kaya T., Dursun A., Calik B., Ozkan O. F., Ulgur H. S., Duzgun O., Monson J., George S., Woods K., Al-Eryani F., Albakry R., Coetzee E., Boutall A., Herman A., Warden C., Mugla N., Forgan T., Mia I., Lambrechts A., Greijdanus, N, Wienholts, K, Ubels, S, Talboom, K, Hannink, G, Wolthuis, A, de Lacy, F, Lefevre, J, Solomon, M, Frasson, M, Rotholtz, N, Denost, Q, Perez, R, Konishi, T, Panis, Y, Rutegard, M, Hompes, R, Rosman, C, van Workum, F, Tanis, P, de Wilt, J, Bremers, A, Ferenschild, F, de Vriendt, S, D'Hoore, A, Bislenghi, G, Farguell, J, Lacy, A, Atienza, P, van Kessel, C, Parc, Y, Voron, T, Collard, M, Muriel, J, Cholewa, H, Mattioni, L, Frontali, A, Polle, S, Polat, F, Obihara, N, Vailati, B, Kusters, M, Tuynmann, J, Hazen, S, Gruter, A, Amano, T, Fujiwara, H, Salomon, M, Ruiz, H, Gonzalez, R, Estefania, D, Avellaneda, N, Carrie, A, Santillan, M, Pachajoa, D, Parodi, M, Gielis, M, Binder, A, Gurtler, T, Riedl, P, Badiani, S, Berney, C, Morgan, M, Hollington, P, da Silva, N, Nair, G, Ho, Y, Lamparelli, M, Kapadia, R, Kroon, H, Dudi-Venkata, N, Liu, J, Sammour, T, Flamey, N, Pattyn, P, Chaoui, A, Vansteenbrugge, L, van den Broek, N, Vanclooster, P, de Gheldere, C, Pletinckx, P, Defoort, B, Dewulf, M, Slavchev, M, Belev, N, Atanasov, B, Krastev, P, Sokolov, M, Maslyankov, S, Gribnev, P, Pavlov, V, Ivanov, T, Karamanliev, M, Filipov, E, Tonchev, P, Aigner, F, Mitteregger, M, Allmer, C, Seitinger, G, Colucci, N, Buchs, N, Ris, F, Toso, C, Gialamas, E, Vuagniaux, A, Chautems, R, Sauvain, M, Daester, S, von Flue, M, Guenin, M, Taha-Mehlitz, S, Hess, G, Martinek, L, Skrovina, M, Machackova, M, Bencurik, V, Uluk, D, Pratschke, J, Dittrich, L, Guel-Klein, S, Perez, D, Grass, J, Melling, N, Mueller, S, Iversen, L, Eriksen, J, Baatrup, G, Al-Najami, I, Bjorsum-Meyer, T, Teras, J, Teras, R, Monib, F, Ahmed, N, Alkady, E, Ali, A, Khedr, G, Abdelaal, A, Ashoush, F, Ewedah, M, Elshennawy, E, Hussein, M, Fernandez-Martinez, D, Garcia-Florez, L, Fernandez-Hevia, M, Suarez-Sanchez, A, Aretxabala, I, Docampo, I, Zabala, J, Tejedor, P, Morales Bernaldo de Quiros, J, Quiroga, I, Navarro-Sanchez, A, Darias, I, Fernandez, C, de La Cruz Cuadrado, C, Sanchez-Guillen, L, Lopez-Rodriguez-Arias, F, Soler-Silva, A, Arroyo, A, Bernal-Sprekelsen, J, Gomez-Abril, S, Gonzalvez, P, Torres, M, Sanchez, T, Antona, F, Lara, J, Montero, J, Mendoza-Moreno, F, Diez-Alonso, M, Matias-Garcia, B, Quiroga-Valcarcel, A, Colas-Ruiz, E, Tasende-Presedo, M, Fernandez-Hurtado, I, Cifuentes-Rodenas, J, Suarez, M, Losada, M, Hernandez, M, Alonso, A, Dieguez, B, Serralta, D, Quintana, R, Lopez, J, Pinto, F, Nieto-Moreno, E, Bonito, A, Santacruz, C, Marcos, E, Septiem, J, Calero-Lillo, A, Alanez-Saavedra, J, Munoz-Collado, S, Lopez-Lara, M, Martinez, M, Herrero, E, Borda, F, Villar, O, Escartin, J, Blas, J, Ferrer, R, Egea, J, Rodriguez-Infante, A, Minguez-Ruiz, G, Carreno-Villarreal, G, Pire-Abaitua, G, Dziakova, J, Rodriguez, C, Aranda, M, Huguet, J, Borda-Arrizabalaga, N, Enriquez-Navascues, J, Echaniz, G, Ansorena, Y, Estaire-Gomez, M, Martinez-Pinedo, C, Barbero-Valenzuela, A, Ruiz-Garcia, P, Kraft, M, Gomez-Jurado, M, Pellino, G, Espin-Basany, E, Cotte, E, Panel, N, Goutard, C, de Angelis, N, Lauka, L, Shaikh, S, Osborne, L, Ramsay, G, Nichita, V, Bhandari, S, Sarmah, P, Bethune, R, Pringle, H, Massey, L, Fowler, G, Hamid, H, de Simone, B, Kynaston, J, Bradley, N, Stienstra, R, Gurjar, S, Mukherjee, T, Chandio, A, Ahmed, S, Singh, B, Runau, F, Chaudhri, S, Siaw, O, Sarveswaran, J, Miu, V, Ashmore, D, Darwich, H, Singh-Ranger, D, Singh, N, Shaban, M, Gareb, F, Petropolou, T, Polydorou, A, Dattani, M, Afzal, A, Bavikatte, A, Sebastian, B, Ward, N, Mishra, A, Manatakis, D, Agalianos, C, Tasis, N, Antonopoulou, M, Karavokyros, I, Charalabopoulos, A, Schizas, D, Baili, E, Syllaios, A, Karydakis, L, Vailas, M, Balalis, D, Korkolis, D, Plastiras, A, Rompou, A, Xenaki, S, Xynos, E, Chrysos, E, Venianaki, M, Christodoulidis, G, Perivoliotis, K, Tzovaras, G, Baloyiannis, I, Ho, M, Ng, S, Mak, T, Futaba, K, Santak, G, Simlesa, D, Cosic, J, Zukanovic, G, Kelly, M, Larkin, J, Mccormick, P, Mehigan, B, Connelly, T, Neary, P, Ryan, J, Mccullough, P, Al-Juaifari, M, Hammoodi, H, Abbood, A, Calabro, M, Muratore, A, La Terra, A, Farnesi, F, Feo, C, Fabbri, N, Pesce, A, Fazzin, M, Roscio, F, Clerici, F, Lucchi, A, Vittori, L, Agostinelli, L, Ripoli, M, Sambucci, D, Porta, A, Sinibaldi, G, Crescentini, G, Larcinese, A, Picone, E, Persiani, R, Biondi, A, Pezzuto, R, Lorenzon, L, Rizzo, G, Coco, C, D'Agostino, L, Spinelli, A, Sacchi, M, Carvello, M, Foppa, C, Maroli, A, Palini, G, Garulli, G, Zanini, N, Delrio, P, Rega, D, Carbone, F, Aversano, A, Pirozzolo, G, Recordare, A, D'Alimonte, L, Vignotto, C, Corbellini, C, Sampietro, G, Lorusso, L, Manzo, C, Ghignone, F, Ugolini, G, Montroni, I, Pasini, F, Ballabio, M, Bisagni, P, Armao, F, Longhi, M, Ghazouani, O, Galleano, R, Tamini, N, Oldani, M, Nespoli, L, Picciariello, A, Altomare, D, Tomasicchio, G, Lantone, G, Catena, F, Giuffrida, M, Annicchiarico, A, Perrone, G, Grossi, U, Santoro, G, Zanus, G, Iacomino, A, Novello, S, Passuello, N, Zucchella, M, Puca, L, Degiuli, M, Reddavid, R, Scabini, S, Aprile, A, Soriero, D, Fioravanti, E, Rottoli, M, Romano, A, Tanzanu, M, Belvedere, A, Mariani, N, Ceretti, A, Opocher, E, Gallo, G, Sammarco, G, de Paola, G, Pucciarelli, S, Marchegiani, F, Spolverato, G, Buzzi, G, Di Saverio, S, Meroni, P, Parise, C, Bottazzoli, E, Lapolla, P, Brachini, G, Cirillo, B, Mingoli, A, Sica, G, Siragusa, L, Bellato, V, Cerbo, D, de Pasqual, C, de Manzoni, G, di Cosmo, M, Alrayes, B, Qandeel, M, Hani, M, Rabadi, A, el Muhtaseb, M, Abdeen, B, Karmi, F, Zilinskas, J, Latkauskas, T, Tamelis, A, Pikuniene, I, Slenfuktas, V, Poskus, T, Kryzauskas, M, Jakubauskas, M, Mikalauskas, S, Jakubauskiene, L, Hassan, S, Altrabulsi, A, Abdulwahed, E, Ghmagh, R, Deeknah, A, Alshareea, E, Elhadi, M, Abujamra, S, Msherghi, A, Tababa, O, Majbar, M, Souadka, A, Benkabbou, A, Mohsine, R, Echiguer, S, Moctezuma-Velazquez, P, Salgado-Nesme, N, Vergara-Fernandez, O, Sainz-Hernandez, J, Alvarez-Bautista, F, Zakaria, A, Zakaria, Z, Wong, M, Ismail, R, Ibrahim, A, Abdullah, N, Julaihi, R, Bhat, S, O'Grady, G, Bissett, I, Lamme, B, Musters, G, Dinaux, A, Grotenhuis, B, Steller, E, Aalbers, A, Leeuwenburgh, M, Rutten, H, Burger, J, Bloemen, J, Ketelaers, S, Waqar, U, Chawla, T, Rauf, H, Rani, P, Talsma, A, Scheurink, L, van Praagh, J, Segelman, J, Nygren, J, Anderin, K, Tiefenthal, M, de Andres, B, Beltran de Heredia, J, Vazquez, A, Gomez, T, Golshani, P, Kader, R, Mohamed, A, Westerterp, M, Marinelli, A, Niemer, Q, Doornebosch, P, Shapiro, J, Vermaas, M, de Graaf, E, van Westreenen, H, Zwakman, M, van Dalsen, A, Vles, W, Nonner, J, Toorenvliet, B, Janssen, P, Verdaasdonk, E, Amelung, F, Peeters, K, Bahadoer, R, Holman, F, Heemskerk, J, Vosbeek, N, Leijtens, J, Taverne, S, Heijnen, B, El-Massoudi, Y, de Groot-Van Veen, I, Hoff, C, Jou-Valencia, D, Consten, E, Burghgraef, T, Geitenbeek, R, Hulshof, L, Slooter, G, Reudink, M, Bouvy, N, Wildeboer, A, Verstappen, S, Pennings, A, van den Hengel, B, Wijma, A, de Haan, J, de Nes, L, Heesink, V, Karsten, T, Heidsma, C, Koemans, W, Dekker, J, van der Zijden, C, Roos, D, Demirkiran, A, van der Burg, S, Oosterling, S, Hoogteijling, T, Wiering, B, Smeeing, D, Havenga, K, Lutfi, H, Tsimogiannis, K, Skoldberg, F, Folkesson, J, den Boer, F, van Schaik, T, van Gerven, P, Sietses, C, Hol, J, Boerma, E, Creemers, D, Schultz, J, Frivold, T, Riis, R, Gregussen, H, Busund, S, Sjo, O, Gaard, M, Krohn, N, Ersryd, A, Leung, E, Sultan, H, Hajjaj, B, Alhisi, A, Khader, A, Mendes, A, Semiao, M, Faria, L, Azevedo, C, da Costa Devesa, H, Martins, S, Jarimba, A, Marques, S, Ferreira, R, Oliveira, A, Ferreira, C, Pereira, R, Surlin, V, Graure, G, Ramboiu, S, Negoi, I, Ciubotaru, C, Stoica, B, Tanase, I, Negoita, V, Florea, S, Macau, F, Vasile, M, Stefanescu, V, Dimofte, G, Lunca, S, Roata, C, Musina, A, Garmanova, T, Agapov, M, Markaryan, D, Eduard, G, Yanishev, A, Abelevich, A, Bazaev, A, Rodimov, S, Filimonov, V, Melnikov, A, Suchkov, I, Drozdov, E, Kostromitskiy, D, Sjostrom, O, Matthiessen, P, Baban, B, Gadan, S, Jadid, K, Staffan, M, Park, J, Rydbeck, D, Lydrup, M, Buchwald, P, Jutesten, H, Darlin, L, Lindqvist, E, Nilsson, K, Larsson, P, Jangmalm, S, Kosir, J, Tomazic, A, Grosek, J, Bozic, T, Zazo, A, Zazo, R, Fares, H, Ayoub, K, Niazi, A, Mansour, A, Abbas, A, Tantoura, M, Hamdan, A, Hassan, N, Hasan, B, Saad, A, Sebai, A, Haddad, A, Maghrebi, H, Kacem, M, Yalkin, O, Samsa, M, Atak, I, Balci, B, Haberal, E, Dogan, L, Gecim, I, Akyol, C, Koc, M, Sivrikoz, E, Piyadeoglu, D, Avanagh, D, Sokmen, S, Bisgin, T, Gunenc, E, Guzel, M, Leventoglu, S, Yuksel, O, Kozan, R, Gobut, H, Cengiz, F, Erdinc, K, Acar, N, Kamer, E, Ozgur, I, Aydin, O, Keskin, M, Bulut, M, Kulle, C, Kara, Y, Sibic, O, Ozata, I, Bugra, D, Balik, E, Cakir, M, Alhardan, A, Colak, E, Aybar, A, Sari, A, Atici, S, Kaya, T, Dursun, A, Calik, B, Ozkan, O, Ulgur, H, Duzgun, O, Monson, J, George, S, Woods, K, Al-Eryani, F, Albakry, R, Coetzee, E, Boutall, A, Herman, A, Warden, C, Mugla, N, Forgan, T, Mia, I, Lambrechts, A, Greijdanus N. G., Wienholts K., Ubels S., Talboom K., Hannink G., Wolthuis A., de Lacy F. B., Lefevre J. H., Solomon M., Frasson M., Rotholtz N., Denost Q., Perez R. O., Konishi T., Panis Y., Rutegard M., Hompes R., Rosman C., van Workum F., Tanis P. J., de Wilt J. H. W., Bremers A. J. A., Ferenschild F. T., de Vriendt S., D'Hoore A., Bislenghi G., Farguell J., Lacy A. M., Atienza P. G., van Kessel C. S., Parc Y., Voron T., Collard M. K., Muriel J. S., Cholewa H., Mattioni L. A., Frontali A., Polle S. W., Polat F., Obihara N. J., Vailati B. B., Kusters M., Tuynmann J. B., Hazen S. J. A., Gruter A. A. J., Amano T., Fujiwara H., Salomon M., Ruiz H., Gonzalez R., Estefania D., Avellaneda N., Carrie A., Santillan M., Pachajoa D. A. P., Parodi M., Gielis M., Binder A. -D., Gurtler T., Riedl P., Badiani S., Berney C., Morgan M., Hollington P., da Silva N., Nair G., Ho Y. M., Lamparelli M., Kapadia R., Kroon H. M., Dudi-Venkata N. N., Liu J., Sammour T., Flamey N., Pattyn P., Chaoui A., Vansteenbrugge L., van den Broek N. E. J., Vanclooster P., de Gheldere C., Pletinckx P., Defoort B., Dewulf M., Slavchev M., Belev N., Atanasov B., Krastev P., Sokolov M., Maslyankov S., Gribnev P., Pavlov V., Ivanov T., Karamanliev M., Filipov E., Tonchev P., Aigner F., Mitteregger M., Allmer C., Seitinger G., Colucci N., Buchs N., Ris F., Toso C., Gialamas E., Vuagniaux A., Chautems R., Sauvain M. -O., Daester S., von Flue M., Guenin M. -O., Taha-Mehlitz S., Hess G. F., Martinek L., Skrovina M., Machackova M., Bencurik V., Uluk D., Pratschke J., Dittrich L. S., Guel-Klein S., Perez D., Grass J. -K., Melling N., Mueller S., Iversen L. H., Eriksen J. D., Baatrup G., Al-Najami I., Bjorsum-Meyer T., Teras J., Teras R. M., Monib F. A., Ahmed N. E. A. E., Alkady E., Ali A. K., Khedr G. A. E., Abdelaal A. S., Ashoush F. M. B., Ewedah M., Elshennawy E. M., Hussein M., Fernandez-Martinez D., Garcia-Florez L. J., Fernandez-Hevia M., Suarez-Sanchez A., Aretxabala I. D. H., Docampo I. L., Zabala J. G., Tejedor P., Morales Bernaldo de Quiros J. T., Quiroga I. B., Navarro-Sanchez A., Darias I. S., Fernandez C. L., de La Cruz Cuadrado C., Sanchez-Guillen L., Lopez-Rodriguez-Arias F., Soler-Silva A., Arroyo A., Bernal-Sprekelsen J. C., Gomez-Abril S. A., Gonzalvez P., Torres M. T., Sanchez T. R., Antona F. B., Lara J. E. S., Montero J. A. A., Mendoza-Moreno F., Diez-Alonso M., Matias-Garcia B., Quiroga-Valcarcel A., Colas-Ruiz E., Tasende-Presedo M. M., Fernandez-Hurtado I., Cifuentes-Rodenas J. A., Suarez M. C., Losada M., Hernandez M., Alonso A., Dieguez B., Serralta D., Quintana R. E. M., Lopez J. M. G., Pinto F. L., Nieto-Moreno E., Bonito A. C., Santacruz C. C., Marcos E. B., Septiem J. G., Calero-Lillo A., Alanez-Saavedra J., Munoz-Collado S., Lopez-Lara M., Martinez M. L., Herrero E. F., Borda F. J. G., Villar O. G., Escartin J., Blas J. L., Ferrer R., Egea J. G., Rodriguez-Infante A., Minguez-Ruiz G., Carreno-Villarreal G., Pire-Abaitua G., Dziakova J., Rodriguez C. S. -C., Aranda M. J. P., Huguet J. M. M., Borda-Arrizabalaga N., Enriquez-Navascues J. M., Echaniz G. E., Ansorena Y. S., Estaire-Gomez M., Martinez-Pinedo C., Barbero-Valenzuela A., Ruiz-Garcia P., Kraft M., Gomez-Jurado M. J., Pellino G., Espin-Basany E., Cotte E., Panel N., Goutard C. -A., de Angelis N., Lauka L., Shaikh S., Osborne L., Ramsay G., Nichita V. -I., Bhandari S., Sarmah P., Bethune R. M., Pringle H. C. M., Massey L., Fowler G. E., Hamid H. K. S., de Simone B. D., Kynaston J., Bradley N., Stienstra R. M., Gurjar S., Mukherjee T., Chandio A., Ahmed S., Singh B., Runau F., Chaudhri S., Siaw O., Sarveswaran J., Miu V., Ashmore D., Darwich H., Singh-Ranger D., Singh N., Shaban M., Gareb F., Petropolou T., Polydorou A., Dattani M., Afzal A., Bavikatte A., Sebastian B., Ward N., Mishra A., Manatakis D., Agalianos C., Tasis N., Antonopoulou M. -I., Karavokyros I., Charalabopoulos A., Schizas D., Baili E., Syllaios A., Karydakis L., Vailas M., Balalis D., Korkolis D., Plastiras A., Rompou A., Xenaki S., Xynos E., Chrysos E., Venianaki M., Christodoulidis G., Perivoliotis K., Tzovaras G., Baloyiannis I., Ho M. -F., Ng S. S., Mak T. W. -C., Futaba K., Santak G., Simlesa D., Cosic J., Zukanovic G., Kelly M. E., Larkin J. O., McCormick P. H., Mehigan B. J., Connelly T. M., Neary P., Ryan J., McCullough P., Al-Juaifari M. A., Hammoodi H., Abbood A. H., Calabro M., Muratore A., La Terra A., Farnesi F., Feo C. V., Fabbri N., Pesce A., Fazzin M., Roscio F., Clerici F., Lucchi A., Vittori L., Agostinelli L., Ripoli M. C., Sambucci D., Porta A., Sinibaldi G., Crescentini G., Larcinese A., Picone E., Persiani R., Biondi A., Pezzuto R., Lorenzon L., Rizzo G., Coco C., D'Agostino L., Spinelli A., Sacchi M. M., Carvello M., Foppa C., Maroli A., Palini G. M., Garulli G., Zanini N., Delrio P., Rega D., Carbone F., Aversano A., Pirozzolo G., Recordare A., D'Alimonte L., Vignotto C., Corbellini C., Sampietro G. M., Lorusso L., Manzo C. A., Ghignone F., Ugolini G., Montroni I., Pasini F., Ballabio M., Bisagni P., Armao F. T., Longhi M., Ghazouani O., Galleano R., Tamini N., Oldani M., Nespoli L., Picciariello A., Altomare D. F., Tomasicchio G., Lantone G., Catena F., Giuffrida M., Annicchiarico A., Perrone G., Grossi U., Santoro G. A., Zanus G., Iacomino A., Novello S., Passuello N., Zucchella M., Puca L., deGiuli M., Reddavid R., Scabini S., Aprile A., Soriero D., Fioravanti E., Rottoli M., Romano A., Tanzanu M., Belvedere A., Mariani N. M., Ceretti A. P., Opocher E., Gallo G., Sammarco G., de Paola G., Pucciarelli S., Marchegiani F., Spolverato G., Buzzi G., Di Saverio S., Meroni P., Parise C., Bottazzoli E. I., Lapolla P., Brachini G., Cirillo B., Mingoli A., Sica G., Siragusa L., Bellato V., Cerbo D., de Pasqual C. A., de Manzoni G., di Cosmo M. A., Alrayes B. M. H., Qandeel M. W. M., Hani M. B., Rabadi A., el Muhtaseb M. S., Abdeen B., Karmi F., Zilinskas J., Latkauskas T., Tamelis A., Pikuniene I., Slenfuktas V., Poskus T., Kryzauskas M., Jakubauskas M., Mikalauskas S., Jakubauskiene L., Hassan S. Y., Altrabulsi A., Abdulwahed E., Ghmagh R., Deeknah A., Alshareea E., Elhadi M., Abujamra S., Msherghi A. A., Tababa O. W. E., Majbar M. A., Souadka A., Benkabbou A., Mohsine R., Echiguer S., Moctezuma-Velazquez P., Salgado-Nesme N., Vergara-Fernandez O., Sainz-Hernandez J. C., Alvarez-Bautista F. E., Zakaria A. D., Zakaria Z., Wong M. P. K., Ismail R., Ibrahim A. F., Abdullah N. A. N., Julaihi R., Bhat S., O'Grady G., Bissett I., Lamme B., Musters G. D., Dinaux A. M., Grotenhuis B. A., Steller E. J., Aalbers A. G. J., Leeuwenburgh M. M., Rutten H. J. T., Burger J. W. A., Bloemen J. G., Ketelaers S. H. J., Waqar U., Chawla T., Rauf H., Rani P., Talsma A. K., Scheurink L., van Praagh J. B., Segelman J., Nygren J., Anderin K., Tiefenthal M., de Andres B., Beltran de Heredia J. P., Vazquez A., Gomez T., Golshani P., Kader R., Mohamed A., Westerterp M., Marinelli A., Niemer Q., Doornebosch P. G., Shapiro J., Vermaas M., de Graaf E. J. R., van Westreenen H. L., Zwakman M., van Dalsen A. D., Vles W. J., Nonner J., Toorenvliet B. R., Janssen P. T. J., Verdaasdonk E. G. G., Amelung F. J., Peeters K. C. M. J., Bahadoer R. R., Holman F. A., Heemskerk J., Vosbeek N., Leijtens J. W. A., Taverne S. B. M., Heijnen B. H. M., El-Massoudi Y., de Groot-Van Veen I., Hoff C., Jou-Valencia D., Consten E. C. J., Burghgraef T. A., Geitenbeek R., Hulshof L. G. W. L., Slooter G. D., Reudink M., Bouvy N. D., Wildeboer A. C. L., Verstappen S., Pennings A. J., van den Hengel B., Wijma A. G., de Haan J., de Nes L. C. F., Heesink V., Karsten T., Heidsma C. M., Koemans W. J., Dekker J. -W. T., van der Zijden C. J., Roos D., Demirkiran A., van der Burg S., Oosterling S. J., Hoogteijling T. J., Wiering B., Smeeing D. P. J., Havenga K., Lutfi H., Tsimogiannis K., Skoldberg F., Folkesson J., den Boer F., van Schaik T. G., van Gerven P., Sietses C., Hol J. C., Boerma E. -J. G., Creemers D. M. J., Schultz J. K., Frivold T., Riis R., Gregussen H., Busund S., Sjo O. H., Gaard M., Krohn N., Ersryd A. L., Leung E., Sultan H., Hajjaj B. N., Alhisi A. J., Khader A. A. E., Mendes A. F. D., Semiao M., Faria L. Q., Azevedo C., da Costa Devesa H. M., Martins S. F., Jarimba A. M. R., Marques S. M. R., Ferreira R. M., Oliveira A., Ferreira C., Pereira R., Surlin V. M., Graure G. M., Ramboiu S. P. S. D., Negoi I., Ciubotaru C., Stoica B., Tanase I., Negoita V. M., Florea S., Macau F., Vasile M., Stefanescu V., Dimofte G. -M., Lunca S., Roata C. -E., Musina A. -M., Garmanova T., Agapov M. N., Markaryan D. G., Eduard G., Yanishev A., Abelevich A., Bazaev A., Rodimov S. V., Filimonov V. B., Melnikov A. A., Suchkov I. A., Drozdov E. S., Kostromitskiy D. N., Sjostrom O., Matthiessen P., Baban B., Gadan S., Jadid K. D., Staffan M., Park J. M., Rydbeck D., Lydrup M. -L., Buchwald P., Jutesten H., Darlin L., Lindqvist E., Nilsson K., Larsson P. -A., Jangmalm S., Kosir J. A., Tomazic A., Grosek J., Bozic T. K., Zazo A., Zazo R., Fares H., Ayoub K., Niazi A., Mansour A., Abbas A., Tantoura M., Hamdan A., Hassan N., Hasan B., Saad A., Sebai A., Haddad A., Maghrebi H., Kacem M., Yalkin O., Samsa M. V., Atak I., Balci B., Haberal E., Dogan L., Gecim I. E., Akyol C., Koc M. A., Sivrikoz E., Piyadeoglu D., Avanagh D. O., Sokmen S., Bisgin T., Gunenc E., Guzel M., Leventoglu S., Yuksel O., Kozan R., Gobut H., Cengiz F., Erdinc K., Acar N. C., Kamer E., Ozgur I., Aydin O., Keskin M., Bulut M. T., Kulle C. B., Kara Y., Sibic O., Ozata I. H., Bugra D., Balik E., Cakir M., Alhardan A., Colak E., Aybar A. B. C., Sari A. C., Atici S. D., Kaya T., Dursun A., Calik B., Ozkan O. F., Ulgur H. S., Duzgun O., Monson J., George S., Woods K., Al-Eryani F., Albakry R., Coetzee E., Boutall A., Herman A., Warden C., Mugla N., Forgan T., Mia I., and Lambrechts A.
- Abstract
Background: The optimal treatment of anastomotic leak after rectal cancer resection is unclear. This worldwide cohort study aimed to provide an overview of four treatment strategies applied. Methods: Patients from 216 centres and 45 countries with anastomotic leak after rectal cancer resection between 2014 and 2018 were included. Treatment was categorized as salvage surgery, faecal diversion with passive or active (vacuum) drainage, and no primary/secondary faecal diversion. The primary outcome was 1-year stoma-free survival. In addition, passive and active drainage were compared using propensity score matching (2: 1). Results: Of 2470 evaluable patients, 388 (16.0 per cent) underwent salvage surgery, 1524 (62.0 per cent) passive drainage, 278 (11.0 per cent) active drainage, and 280 (11.0 per cent) had no faecal diversion. One-year stoma-free survival rates were 13.7, 48.3, 48.2, and 65.4 per cent respectively. Propensity score matching resulted in 556 patients with passive and 278 with active drainage. There was no statistically significant difference between these groups in 1-year stoma-free survival (OR 0.95, 95 per cent c.i. 0.66 to 1.33), with a risk difference of -1.1 (95 per cent c.i. -9.0 to 7.0) per cent. After active drainage, more patients required secondary salvage surgery (OR 2.32, 1.49 to 3.59), prolonged hospital admission (an additional 6 (95 per cent c.i. 2 to 10) days), and ICU admission (OR 1.41, 1.02 to 1.94). Mean duration of leak healing did not differ significantly (an additional 12 (-28 to 52) days). Conclusion: Primary salvage surgery or omission of faecal diversion likely correspond to the most severe and least severe leaks respectively. In patients with diverted leaks, stoma-free survival did not differ statistically between passive and active drainage, although the increased risk of secondary salvage surgery and ICU admission suggests residual confounding.
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- 2023
5. C-reactive protein (CRP) trajectory as a predictor of anastomotic leakage after rectal cancer resection: A multicentre cohort study
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Hoek, V. T., Sparreboom, C. L., Wolthuis, A. M., Menon, A. G., Kleinrensink, G. J., D'Hoore, A., Komen, N., Lange, J. F., van Westreenen, H. L., Doornebosch, P. G., Dekker, J. W. T., Daams, F., Lips, D. J., van Grevenstein, W. M. U., Karsten, T. M., Hoek, V. T., Sparreboom, C. L., Wolthuis, A. M., Menon, A. G., Kleinrensink, G. J., D'Hoore, A., Komen, N., Lange, J. F., van Westreenen, H. L., Doornebosch, P. G., Dekker, J. W. T., Daams, F., Lips, D. J., van Grevenstein, W. M. U., and Karsten, T. M.
- Abstract
Aim: This study aimed to identify whether CRP-trajectory measurement, including increase in CRP-level of 50 mg/l per day, is an accurate predictor of anastomotic leakage (AL) in patients undergoing resection for rectal cancer. Methods: A prospective multicentre database was used. CRP was recorded on the first three postoperative days. Sensitivity, specificity, positive and negative predictive values, and area under the receiver operator characteristic (ROC) curve were used to analyse performances of CRP-trajectory measurements between postoperative day (POD) 1–2, 2–3, 1–3 and between any two days. Results: A total of 271 patients were included in the study. AL was observed in 12.5% (34/271). Increase in CRP-level of 50 mg/l between POD 1–2 had a negative predictive value of 0.92, specificity of 0.71 and sensitivity of 0.57. Changes in CRP-levels between POD 2–3 were associated with a negative predictive value, specificity and sensitivity of 0.89, 0.93 and 0.26, respectively. Changes in CRP-levels between POD 1–3 showed a negative predictive value of 0.94, specificity of 0.76 and sensitivity of 0.65. In addition, 50 mg/l changes between any two days showed a negative predictive value of 0.92, specificity of 0.66 and sensitivity of 0.62. The area under the ROC curve for all CRP-trajectory measurements ranged from 0.593–0.700. Conclusion: The present study showed that CRP-trajectory between postoperative days lacks predictive value to singularly rule out AL. Early and safe discharge in patients undergoing rectal surgery for adenocarcinoma cannot be guaranteed based on this parameter. High negative predictive values are mainly caused by the relatively low prevalence of AL.
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- 2022
6. Slowly resorbable biosynthetic mesh:2-year results in VHWG grade 3 hernia repair
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Van Rooijen, M. M. J., Tollens, T., Jorgensen, L. N., Reilingh, T. S. de Vries, Piessen, G., Koeckerling, F., Miserez, M., Windsor, A. C. J., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W. M., Koch, A., Jeekel, J., Van Rooijen, M. M. J., Tollens, T., Jorgensen, L. N., Reilingh, T. S. de Vries, Piessen, G., Koeckerling, F., Miserez, M., Windsor, A. C. J., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W. M., Koch, A., and Jeekel, J.
- Abstract
Introduction: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm 2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.
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- 2022
7. Changes in rectal cancer treatment after the introduction of a national screening program:Increasing use of less invasive strategies within a national cohort
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Giesen, L. J.X., Olthof, P. B., Elferink, M. A.G., van Westreenen, H. L., Beets, G. L., Verhoef, C., Dekker, J. W.T., Giesen, L. J.X., Olthof, P. B., Elferink, M. A.G., van Westreenen, H. L., Beets, G. L., Verhoef, C., and Dekker, J. W.T.
- Abstract
Aim: Organ preserving treatment strategies and the introduction of a colorectal cancer-screening program have likely influenced the resection rates of rectal cancer. The aim of this study is to assess the influence of these developments on rectal cancer treatment and resection rates in the Netherlands. Methods: Patients diagnosed with non-metastatic rectal cancer between 2013 and 2018, were selected from the Netherlands Cancer Registry. The distribution of surgical and neo-adjuvant treatment and resection rates were analyzed and compared over time. Results: Between 2013 and 2018 22640 patients were diagnosed with non-metastatic rectal cancer. The incidence of early stage (cT1) disease increased from 141 (4%) in 2013 to 448 (12%) in 2018. The use of neoadjuvant radiotherapy and chemo-radiotherapy dropped from 39% to 21% and 34%–25%, respectively. A decrease in surgical resection rates (including TEM) was observed from 85% to 73%. The proportion of patients who underwent endoscopic resections increased from 3% to 10%. The decrease in surgical resection rates was larger in patients treated with neo-adjuvant chemo-radiotherapy. Conclusion: An increase in stage I disease is noted after the introduction of the screening program. Surgical resection rates for rectal cancer have fallen over time. Endoscopic resections due to more early-stage disease probably accounts for a large part of this decline. Furthermore, a watch and wait approach after neo-adjuvant chemo-radiotherapy may play an important role as well.
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- 2022
8. Impact of the COVID-19 pandemic on surgical care in the Netherlands
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de Graaff, Michelle R., Hogenbirk, Rianne N. M., Janssen, Yester F., Elfrink, Arthur K. E., Liem, Ronald S. L., Nienhuijs, Simon W., de Vries, Jean-Paul P. M., Elshof, Jan-Willem, Verdaasdonk, Emiel, Melenhorst, Jarno, van Westreenen, H. L., Besselink, Marc G. H., Ruurda, Jelle P., Henegouwen, Mark I. van Berge, Klaase, Joost M., den Dulk, Marcel, van Heijl, Mark, Hegeman, Johannes H., Braun, Jerry, Voeten, Daan M., Wurdemann, Franka S., Warps, Anne-Loes K., Alberga, Anna J., Suurmeijer, J. Annelie, Akpinar, Erman O., Wolfhagen, Nienke, van den Boom, Anne Loes, Bolster-van Eenennaam, Marieke J., van Duijvendijk, Peter, Heineman, David J., Wouters, Michel W. J. M., Kruijff, Schelto, Waalboer, R.B., de Graaff, Michelle R., Hogenbirk, Rianne N. M., Janssen, Yester F., Elfrink, Arthur K. E., Liem, Ronald S. L., Nienhuijs, Simon W., de Vries, Jean-Paul P. M., Elshof, Jan-Willem, Verdaasdonk, Emiel, Melenhorst, Jarno, van Westreenen, H. L., Besselink, Marc G. H., Ruurda, Jelle P., Henegouwen, Mark I. van Berge, Klaase, Joost M., den Dulk, Marcel, van Heijl, Mark, Hegeman, Johannes H., Braun, Jerry, Voeten, Daan M., Wurdemann, Franka S., Warps, Anne-Loes K., Alberga, Anna J., Suurmeijer, J. Annelie, Akpinar, Erman O., Wolfhagen, Nienke, van den Boom, Anne Loes, Bolster-van Eenennaam, Marieke J., van Duijvendijk, Peter, Heineman, David J., Wouters, Michel W. J. M., Kruijff, Schelto, and Waalboer, R.B.
- Abstract
BACKGROUND: The COVID-19 pandemic caused disruption of regular healthcare leading to reduced hospital attendances, repurposing of surgical facilities, and cancellation of cancer screening programmes. This study aimed to determine the impact of COVID-19 on surgical care in the Netherlands. METHODS: A nationwide study was conducted in collaboration with the Dutch Institute for Clinical Auditing. Eight surgical audits were expanded with items regarding alterations in scheduling and treatment plans. Data on procedures performed in 2020 were compared with those from a historical cohort (2018-2019). Endpoints included total numbers of procedures performed and altered treatment plans. Secondary endpoints included complication, readmission, and mortality rates. RESULTS: Some 12 154 procedures were performed in participating hospitals in 2020, representing a decrease of 13.6 per cent compared with 2018-2019. The largest reduction (29.2 per cent) was for non-cancer procedures during the first COVID-19 wave. Surgical treatment was postponed for 9.6 per cent of patients. Alterations in surgical treatment plans were observed in 1.7 per cent. Time from diagnosis to surgery decreased (to 28 days in 2020, from 34 days in 2019 and 36 days in 2018; P < 0.001). For cancer-related procedures, duration of hospital stay decreased (5 versus 6 days; P < 0.001). Audit-specific complications, readmission, and mortality rates were unchanged, but ICU admissions decreased (16.5 versus 16.8 per cent; P < 0.001). CONCLUSION: The reduction in the number of surgical operations was greatest for those without cancer. Where surgery was undertaken, it appeared to be delivered safely, with similar complication and mortality rates, fewer admissions to ICU, and a shorter hospital stay.
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- 2022
9. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk ('ugly') locally advanced rectal cancer:study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)
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van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van 't Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., Burger, J. W.A., van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van 't Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., and Burger, J. W.A.
- Abstract
BACKGROUND: The presence of mesorectal fascia (MRF) invasion, grade 4 extramural venous invasion (EMVI), tumour deposits (TD) or extensive or bilateral extramesorectal (lateral) lymph nodes (LLN) on MRI has been suggested to identify patients with indisputable, extensive locally advanced rectal cancer (LARC), at high risk of treatment failure. The aim of this study is to evaluate whether or not intensified chemotherapy prior to neoadjuvant chemoradiotherapy improves the complete response (CR) rate in these patients. METHODS: This multicentre, single-arm, open-label, phase II trial will include 128 patients with non-metastatic high-risk LARC (hr-LARC), fit for triplet chemotherapy. To ensure a study population with indisputable, unfavourable prognostic characteristics, hr-LARC is defined as LARC with on baseline MRI at least one of the following characteristics; MRF invasion, EMVI grade 4, enlarged bilateral or extensive LLN at high risk of an incomplete resection, or TD. Exclusion criteria are the presence of a homozygous DPD deficiency, distant metastases, any chemotherapy within the past 6 months, previous radiotherapy within the pelvic area precluding standard chemoradiotherapy, and any contraindication for the planned treatment. All patients will be planned for six two-weekly cycles of FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) prior to chemoradiotherapy (25 × 2 Gy or 28 × 1.8 Gy with concomitant capecitabine). A resection will be performed following radiological confirmation of resectable disease after the completion of chemoradiotherapy. A watch and wait strategy is allowed in case of a clinical complete response. The primary endpoint is the CR rate, described as a pathological CR or a sustained clinical CR one year after chemoradiotherapy. The main secondary objectives are long-term oncological outcomes, radiological and pathological response, the number of resections with clear margins, treatment-related toxicity, perioperative com
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- 2022
10. Slowly resorbable biosynthetic mesh:2-year results in VHWG grade 3 hernia repair
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Van Rooijen, M. M.J., Tollens, T., Jørgensen, L. N., de Vries Reilingh, T. S., Piessen, G., Köckerling, F., Miserez, M., Windsor, A. C.J., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W.M., Koch, A., Jeekel, J., Van Rooijen, M. M.J., Tollens, T., Jørgensen, L. N., de Vries Reilingh, T. S., Piessen, G., Köckerling, F., Miserez, M., Windsor, A. C.J., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W.M., Koch, A., and Jeekel, J.
- Abstract
Introduction: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.
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- 2022
11. Slowly resorbable biosynthetic mesh:2-year results in VHWG grade 3 hernia repair
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Van Rooijen, M. M.J., Tollens, T., Jørgensen, L. N., de Vries Reilingh, T. S., Piessen, G., Köckerling, F., Miserez, M., Windsor, A. C.J., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W.M., Koch, A., Jeekel, J., Van Rooijen, M. M.J., Tollens, T., Jørgensen, L. N., de Vries Reilingh, T. S., Piessen, G., Köckerling, F., Miserez, M., Windsor, A. C.J., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W.M., Koch, A., and Jeekel, J.
- Abstract
Introduction: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.
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- 2022
12. Neoadjuvant FOLFOXIRI prior to chemoradiotherapy for high-risk (“ugly”) locally advanced rectal cancer: study protocol of a single-arm, multicentre, open-label, phase II trial (MEND-IT)
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MS Medische Oncologie, Cancer, van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van ‘t Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., Burger, J. W.A., MS Medische Oncologie, Cancer, van den Berg, K., Schaap, D. P., Voogt, E. L.K., Buffart, T. E., Verheul, H. M.W., de Groot, J. W.B., Verhoef, C., Melenhorst, J., Roodhart, J. M.L., de Wilt, J. H.W., van Westreenen, H. L., Aalbers, A. G.J., van ‘t Veer, M., Marijnen, C. A.M., Vincent, J., Simkens, L. H.J., Peters, N. A.J.B., Berbée, M., Werter, I. M., Snaebjornsson, P., Peulen, H. M.U., van Lijnschoten, I. G., Roef, M. J., Nieuwenhuijzen, G. A.P., Bloemen, J. G., Willems, J. M.W.E., Creemers, G. J.M., Nederend, J., Rutten, H. J.T., and Burger, J. W.A.
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- 2022
13. Impact of the COVID-19 pandemic on surgical care in the Netherlands
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MS CGO, Cancer, de Graaff, Michelle R., Hogenbirk, Rianne N. M., Janssen, Yester F., Elfrink, Arthur K. E., Liem, Ronald S. L., Nienhuijs, Simon W., de Vries, Jean-Paul P. M., Elshof, Jan-Willem, Verdaasdonk, Emiel, Melenhorst, Jarno, van Westreenen, H. L., Besselink, Marc G. H., Ruurda, Jelle P., Henegouwen, Mark I. van Berge, Klaase, Joost M., den Dulk, Marcel, van Heijl, Mark, Hegeman, Johannes H., Braun, Jerry, Voeten, Daan M., Wurdemann, Franka S., Warps, Anne-Loes K., Alberga, Anna J., Suurmeijer, J. Annelie, Akpinar, Erman O., Wolfhagen, Nienke, van den Boom, Anne Loes, Bolster-van Eenennaam, Marieke J., van Duijvendijk, Peter, Heineman, David J., Wouters, Michel W. J. M., Kruijff, Schelto, MS CGO, Cancer, de Graaff, Michelle R., Hogenbirk, Rianne N. M., Janssen, Yester F., Elfrink, Arthur K. E., Liem, Ronald S. L., Nienhuijs, Simon W., de Vries, Jean-Paul P. M., Elshof, Jan-Willem, Verdaasdonk, Emiel, Melenhorst, Jarno, van Westreenen, H. L., Besselink, Marc G. H., Ruurda, Jelle P., Henegouwen, Mark I. van Berge, Klaase, Joost M., den Dulk, Marcel, van Heijl, Mark, Hegeman, Johannes H., Braun, Jerry, Voeten, Daan M., Wurdemann, Franka S., Warps, Anne-Loes K., Alberga, Anna J., Suurmeijer, J. Annelie, Akpinar, Erman O., Wolfhagen, Nienke, van den Boom, Anne Loes, Bolster-van Eenennaam, Marieke J., van Duijvendijk, Peter, Heineman, David J., Wouters, Michel W. J. M., and Kruijff, Schelto
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- 2022
14. A multicentre cohort study of serum and peritoneal biomarkers to predict anastomotic leakage after rectal cancer resection
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Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, Lange, J F, Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, and Lange, J F
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- 2020
15. Population-based study of morbidity risk associated with pathological complete response after chemoradiotherapy for rectal cancer
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van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, van Westreenen, H L, van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, and van Westreenen, H L
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- 2020
16. Population-based study of morbidity risk associated with pathological complete response after chemoradiotherapy for rectal cancer
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van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, van Westreenen, H L, van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, and van Westreenen, H L
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- 2020
17. A multicentre cohort study of serum and peritoneal biomarkers to predict anastomotic leakage after rectal cancer resection
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Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, Lange, J F, Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, and Lange, J F
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- 2020
18. A multicentre cohort study of serum and peritoneal biomarkers to predict anastomotic leakage after rectal cancer resection
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Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, Lange, J F, Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, and Lange, J F
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- 2020
19. Population-based study of morbidity risk associated with pathological complete response after chemoradiotherapy for rectal cancer
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van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, van Westreenen, H L, van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, and van Westreenen, H L
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- 2020
20. A multicentre cohort study of serum and peritoneal biomarkers to predict anastomotic leakage after rectal cancer resection
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MS CGO, Cancer, MS Gynaecologische Oncologie, Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, Lange, J F, MS CGO, Cancer, MS Gynaecologische Oncologie, Sparreboom, C L, Komen, N, Rizopoulos, D, Verhaar, A P, Dik, W A, Wu, Z, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Bayon, Y, Peppelenbosch, M P, Wolthuis, A M, D'Hoore, A, and Lange, J F
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- 2020
21. Population-based study of morbidity risk associated with pathological complete response after chemoradiotherapy for rectal cancer
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Cancer, MS Radiotherapie, van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, van Westreenen, H L, Cancer, MS Radiotherapie, van der Sluis, F J, Couwenberg, A M, de Bock, G H, Intven, M P W, Reerink, O, van Leeuwen, B L, and van Westreenen, H L
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- 2020
22. A multicentre cohort study of serum and peritoneal biomarkers to predict anastomotic leakage after rectal cancer resection
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Sparreboom, Cloë, Komen, NAP, Rizopoulos, Dimitris, Verhaar, Auke, Dik, Wim, Wu, Zhouqiao, van Westreenen, H L, Doornebosch, PG, Dekker, JW, Menon, AG, Daams, F, Lips, D, van Grevenstein, WMU, Karsten, TM, Bayon, Y, Peppelenbosch, Maikel, Wolthuis, AM, D'Hoore, A, Lange, Johan, Sparreboom, Cloë, Komen, NAP, Rizopoulos, Dimitris, Verhaar, Auke, Dik, Wim, Wu, Zhouqiao, van Westreenen, H L, Doornebosch, PG, Dekker, JW, Menon, AG, Daams, F, Lips, D, van Grevenstein, WMU, Karsten, TM, Bayon, Y, Peppelenbosch, Maikel, Wolthuis, AM, D'Hoore, A, and Lange, Johan
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- 2020
23. Transanal total mesorectal excision: how are we doing so far?
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Sparreboom, C.L. (Cloë), Komen, N.A.P. (Niels), Rizopoulos, D. (Dimitris), van Westreenen, H. L., Doornebosch, P. (Pascal), Dekker, J.W., Menon, A.G., Tuynman, J.B., Daams, F. (Freek), Lips, D., van Grevenstein, WMU, Karsten, T.M. (Thomas), Lange, J.F. (Johan), D'Hoore, A. (André), Wolthuis, A.M., Sparreboom, C.L. (Cloë), Komen, N.A.P. (Niels), Rizopoulos, D. (Dimitris), van Westreenen, H. L., Doornebosch, P. (Pascal), Dekker, J.W., Menon, A.G., Tuynman, J.B., Daams, F. (Freek), Lips, D., van Grevenstein, WMU, Karsten, T.M. (Thomas), Lange, J.F. (Johan), D'Hoore, A. (André), and Wolthuis, A.M.
- Abstract
Aim This subgroup analysis of a prospective multicentre cohort study aims to compare postoperative morbidity between transanal total mesorectal excision (TaTME) and laparoscopic total mesorectal excision (LaTME). Method The study was designed as a subgroup analysis of a prospective multicentre cohort study. Patients undergoing TaTME or LaTME for rectal cancer were selected. All patients were followed up until the first visit to the outpatient clinic after hospital discharge. Postoperative complications were classified according to the Clavien–Dindo classification and the comprehensive complication index (CCI). Propensity score matching was performed. Results In total, 220 patients were selected from the overall prospective multicentre cohort study. After propensity score matching, 48 patients from each group were compared. The median tumour height for TaTME was 10.0 cm (6.0–10.8) and for LaTME was 9.5 cm (7.0–12.0) (P = 0.459). The duration of surgery and anaesthesia were both significantly longer for TaTME (221 vs 180 min, P < 0.001, and 264 vs 217 min, P < 0.001). TaTME was not converted to laparotomy whilst surgery in five patients undergoing LaTME was converted to laparotomy (0.0% vs 10.4%, P = 0.056). No statistically significant differences were observed for Clavien–Dindo classification, CCI, readmissions, reoperations and mortality. Conclusion The study showed that TaTME is a safe and feasible approach for rectal cancer resection. This new technique obtained similar postoperative morbidity to LaTME.
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- 2019
- Full Text
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24. Transanal total mesorectal excision: how are we doing so far?
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Sparreboom, Cloë, Komen, NAP, Rizopoulos, Dimitris, van Westreenen, H L, Doornebosch, PG, Dekker, JW, Menon, AG, Tuynman, JB, Daams, F, Lips, D, van Grevenstein, WMU, Karsten, TM, Lange, Johan, D'Hoore, A, Wolthuis, AM, Sparreboom, Cloë, Komen, NAP, Rizopoulos, Dimitris, van Westreenen, H L, Doornebosch, PG, Dekker, JW, Menon, AG, Tuynman, JB, Daams, F, Lips, D, van Grevenstein, WMU, Karsten, TM, Lange, Johan, D'Hoore, A, and Wolthuis, AM
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- 2019
25. Transanal total mesorectal excision: how are we doing so far?
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Verpleegafd Vaatchirurgie D4 Oost, MS CGO, Cancer, Sparreboom, C L, Komen, N, Rizopoulos, D, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Tuynman, J B, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Lange, J F, D'Hoore, A, Wolthuis, A M, Verpleegafd Vaatchirurgie D4 Oost, MS CGO, Cancer, Sparreboom, C L, Komen, N, Rizopoulos, D, van Westreenen, H L, Doornebosch, P G, Dekker, J W T, Menon, A G, Tuynman, J B, Daams, F, Lips, D, van Grevenstein, W M U, Karsten, T M, Lange, J F, D'Hoore, A, and Wolthuis, A M
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- 2019
26. A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair:a research protocol
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van Rooijen, M M J, Jairam, A P, Tollens, T, Jørgensen, L N, de Vries Reilingh, T S, Piessen, G, Köckerling, F, Miserez, M, Windsor, A C J, Berrevoet, F, Fortelny, R H, Dousset, B, Woeste, G, van Westreenen, H L, Gossetti, F, Lange, J F, Tetteroo, G W M, Koch, A, Kroese, L F, Jeekel, J, van Rooijen, M M J, Jairam, A P, Tollens, T, Jørgensen, L N, de Vries Reilingh, T S, Piessen, G, Köckerling, F, Miserez, M, Windsor, A C J, Berrevoet, F, Fortelny, R H, Dousset, B, Woeste, G, van Westreenen, H L, Gossetti, F, Lange, J F, Tetteroo, G W M, Koch, A, Kroese, L F, and Jeekel, J
- Abstract
BACKGROUND: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients.METHODS: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery.CONCLUSION: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients.TRIAL REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .
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- 2018
27. A post-market, prospective, multi-center, single-arm clinical investigation of Phasix mesh for VHWG grade 3 midline incisional hernia repair: a research protocol
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van Rooijen, Machteld, Jairam, An, Tollens, T, Jorgensen, LN, Reilingh, TSD, Piessen, G, Kockerling, F, Miserez, M, Windsor, ACJ, Berrevoet, F, Fortelny, R H, Dousset, B, Woeste, G, van Westreenen, H L, Gossetti, F, Lange, Johan, Tetteroo, GWM, Koch, A, Kroese, Leonard, Jeekel, J (Hans), van Rooijen, Machteld, Jairam, An, Tollens, T, Jorgensen, LN, Reilingh, TSD, Piessen, G, Kockerling, F, Miserez, M, Windsor, ACJ, Berrevoet, F, Fortelny, R H, Dousset, B, Woeste, G, van Westreenen, H L, Gossetti, F, Lange, Johan, Tetteroo, GWM, Koch, A, Kroese, Leonard, and Jeekel, J (Hans)
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- 2018
28. A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair:a research protocol
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van Rooijen, M M J, Jairam, A P, Tollens, T, Jørgensen, L N, de Vries Reilingh, T S, Piessen, G, Köckerling, F, Miserez, M, Windsor, A C J, Berrevoet, F, Fortelny, R H, Dousset, B, Woeste, G, van Westreenen, H L, Gossetti, F, Lange, J F, Tetteroo, G W M, Koch, A, Kroese, L F, Jeekel, J, van Rooijen, M M J, Jairam, A P, Tollens, T, Jørgensen, L N, de Vries Reilingh, T S, Piessen, G, Köckerling, F, Miserez, M, Windsor, A C J, Berrevoet, F, Fortelny, R H, Dousset, B, Woeste, G, van Westreenen, H L, Gossetti, F, Lange, J F, Tetteroo, G W M, Koch, A, Kroese, L F, and Jeekel, J
- Abstract
BACKGROUND: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients.METHODS: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery.CONCLUSION: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients.TRIAL REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .
- Published
- 2018
29. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer
- Author
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Borstlap, W A A, Tanis, PJ, Koedam, T W A, Marijnen, CAM, Cunningham, C, Dekker, E, van Leerdam, ME, Meijer, G, van Grieken, N, Nagtegaal, ID, Punt, CJA, Dijkgraaf, MGW, de Wilt, JHW, Beets, G, de Graaf, EJ, van Geloven, AAW, Gerhards, MF, van Westreenen, H L, van de Ven, AWH, van Duijvendijk, P, de Hingh, IHJT, Leijtens, JWA, Sietses, C, Spillenaar-Bilgen, E J, Vuylsteke, RJCLM, Hoff, C, Burger, Pim, van Grevenstein, WMU, Pronk, A, Bosker, RJI, Prins, H, Smits, A B, Bruin, S, Zimmerman, DD, Stassen, LPS, Dunker, M S, Westerterp, M, Coene, PP, Stoot, J, Bemelman, WA, Tuynman, JB, Borstlap, W A A, Tanis, PJ, Koedam, T W A, Marijnen, CAM, Cunningham, C, Dekker, E, van Leerdam, ME, Meijer, G, van Grieken, N, Nagtegaal, ID, Punt, CJA, Dijkgraaf, MGW, de Wilt, JHW, Beets, G, de Graaf, EJ, van Geloven, AAW, Gerhards, MF, van Westreenen, H L, van de Ven, AWH, van Duijvendijk, P, de Hingh, IHJT, Leijtens, JWA, Sietses, C, Spillenaar-Bilgen, E J, Vuylsteke, RJCLM, Hoff, C, Burger, Pim, van Grevenstein, WMU, Pronk, A, Bosker, RJI, Prins, H, Smits, A B, Bruin, S, Zimmerman, DD, Stassen, LPS, Dunker, M S, Westerterp, M, Coene, PP, Stoot, J, Bemelman, WA, and Tuynman, JB
- Published
- 2016
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