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1. In-hospital Delay of Appendectomy in Acute, Complicated Appendicitis

Author

Bolmers, M.D.M., de Jonge, J., Bom, W.J., van Rossem, C.C., van Geloven, A.A.W., Bemelman, W.A., Van Acker, G.J., Akkermans, B., Akkersdijk, G.J., Algie, G.D., Allema, J.H., Andeweg, C.S., Appeldoorn, N., van Baal, J.G., Bakker, C.M.den, Bartels, S.A., van den Berg, C., Boekestijn, B., Boer, F.C.den, Boerma, D., van den Boom, A.L., Boute, M.C., Bouwense, S.A., Bransen, J., van Brussel, F.A., Busch, O.R., de Castro, S.M., Cense, H.A., Croese, C., van dalen, T., Dawson, I., van Dessel, E., Dettmers, R., Dhar, N., Dohmen, F.Y., van Dongen, K.W., van Duijvendijk, P., Dulfer, R.R., Dwars, B.J., Eerenberg, J.P., van der Elst, M., van den Ende, E., Fassaert, L.M., Fikkers, J.T., Foppen, J.W., Furnee, E.J., Garssen, F.P., Gerhards, M.F., van Goor, H., de Graaf, J.S., Graat, L.J., Grootr, J., van der Ham, A.C., Hamming, J.F., Hamminga, J.T., van der Harst, E., Heemskerk, J., Heijne, A., Heikens, J.T., Heineman, E., Hertogs, R., van Heurn, E., van den Hil, L.C., Hooftwijk, A.G., Hulsker, C.C., Hunen, D.R., Ibelings, M.S., Klaase, J.M., Klicks, R., Knaapen, L., Kortekaas, R.T., Kruyt, F., Kwant, S., Lases, S.S., Lettinga, T., Loupatty, A., Matthijsen, R.A., Minnee, R.C., Mirck, B., Mitalas, L., Moes, D., Moorman, A.M., Nieuwenhuijs, V.B., Nieuwenhuizen, G.A., Nijk, P.D., Omloo, J.M., Ottenhof, A.G., Palamba, H.W., van der Peet, D.L., Pereboom, I.T., Plaisier, P.W., van der Ploeg, A.P., Raber, M.H., Reijen, M.M., Rijna, H., Rosman, C., Roumen, R.M., Scmitz, R.F., Schouten van der Velden, A.P., Scheurs, W.H., Sigterman, T.A., Smeets, H.J., Sonnevled, D.J., Sosef, M.N., Spoor, S.F., Stassen, L.P., van Steensel, L., Stortelder, E., Straatman, J., van Susante, H.J., Suykerbuyk de Hoog, D.E., Terwisscha van Scheltinga, C., Toorenvliet, B.R., Verbeek, P.C., Verseveld, M., Volders, J.H., Vriens, M.R., Vriens, P.W., Vrouenraets, B.C., van de wall, B.J., Wegdam, J.A., Westerduin, E., Wever, J.J., Wijfels, N.A., Wijnhoven, B.P., Winkel, T.A., van der Zee, D.C., Zeillemaker, A.M., and Zietse, C.

Published
2022
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2. Discrepancies between Intraoperative and Histological Evaluation of the Appendix in Acute Appendicitis

Author

Bolmers, Matthijs D.M., de Jonge, Joske, van Rossem, Charles C., van Geloven, Anna A.W., Bemelman, Willem A., Van Acker, G.J., Akkermans, B., Akkersdijk, G.J., Algie, G.D., Allema, J.H., Andeweg, C.S., Appeldoorn, N., van Baal, J.G., den Bakker, C.M., Bartels, S.A., van den Berg, C., Boekestijn, B., den Boer, F.C., Boerma, D., van den Boom, A.L., Boute, M.C., Bouwense, S.A., Bransen, J., van Brussel, F.A., Busch, O.R., de Castro, S.M., Cense, H.A., Croese, C., van dalen, T., Dawson, I., van Dessel, E., Dettmers, R., Dhar, N., Dohmen, F.Y., van Dongen, K.W., van Duijvendijk, P., Dulfer, R.R., Dwars, B.J., Eerenberg, J.P., van der Elst, M., van den Ende, E., Fassaert, L.M., Fikkers, J.T., Foppen, J.W., Furnee, E.J., Garssen, F.P., Gerhards, M.F., van Goor, H., de Graaf, J.S., Graat, L.J., Grootr, J., van der Ham, A.C., Hamming, J.F., Hamminga, J.T., van der Harst, E., Heemskerk, J., Heijne, A., Heikens, J.T., Heineman, E., Hertogs, R., van Heurn, E., van den Hil, L.C., Hooftwijk, A.G., Hulsker, C.C., Hunen, D.R., Ibelings, M.S., Klaase, J.M., Klicks, R., Knaapen, L., Kortekaas, R.T., Kruyt, F., Kwant, S., Lases, S.S., Lettinga, T., Loupatty, A., Matthijsen, R.A., Minnee, R.C., Mirck, B., Mitalas, L., Moes, D., Moorman, A.M., Nieuwenhuijs, V.B., Nieuwenhuizen, G.A., Nijk, P.D., Omloo, J.M., Ottenhof, A.G., Palamba, H.W., van der Peet, D.L., Pereboom, I.T., Plaisier, P.W., van der Ploeg, A.P., Raber, M.H., Reijen, M.M., Rijna, H., Rosman, C., Roumen, R.M., Scmitz, R.F., van der Velden, A.P.Schouten, Scheurs, W.H., Sigterman, T.A., Smeets, H.J., Sonnevled, D.J., Sosef, M.N., Spoor, S.F., Stassen, L.P., van Steensel, L., Stortelder, E., Straatman, J., van Susante, H.J., de Hoog, D.E.Suykerbuyk, Te van Scheltinga, C.rwisscha, Toorenvliet, B.R., Verbeek, P.C., Verseveld, M., Volders, J.H., Vriens, M.R., Vriens, P.W., Vrouenraets, B.C., van de wall, B.J., Wegdam, J.A., Westerduin, E., Wever, J.J., Wijfels, N.A., Wijnhoven, B.P., Winkel, T.A., van der Zee, D.C., Zeillemaker, A.M., and Zietse, C.

Published
2020
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3. Volume of surgery for benign colorectal polyps in the last 11 years

Author

Beaumont, H., Tuynman, J., de Bruin, G., Van Geloven, A.A.W., Bruins Slot, W., van der Hulst, R.W.M., Vuylsteke, R., Cahen, D., Baan, A.H., Dekkers, P., den Boer, F.C., Depla, A.T.C.M., Bruin, S., Jansen, J.M., Gerhards, M.F., Stokkers, P., van Tets, W.F., Mundt, M.W., van de Ven, A.W.H., Peters, J., Cense, H.A., van der Spek, B.W., Dunker, M.S., van Leerdam, M.E., Aalbers, A.G., Vlug, M., Sonneveld, D.J.A., Bronzwaer, Maxime E.S., Koens, Lianne, Bemelman, Willem A., Dekker, Evelien, and Fockens, Paul

Published
2018
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5. Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development

Author

Bakker, C.M., Schaafsma, F.G., Meij, E. van der, Meijerink, W.J.H.J., Heuvel, B. van den, Baan, A.H., Davids, P.H., Scholten, P.C., Meij, S. van der, Baal, W.M. van, Dalsen, A.D. van, Lips, D.J., Steeg, J.W. van der, Leclercq, W.K., Geomini, P.M., Consten, E.C., Koops, S.E. Schraffordt, Castro, S.M. de, Kesteren, P.J. van, Cense, H.A., Stockmann, H.B., Cate, A.D. Ten, Bonjer, H.J., Huirne, J.A., Anema, J.R., Bakker, C.M., Schaafsma, F.G., Meij, E. van der, Meijerink, W.J.H.J., Heuvel, B. van den, Baan, A.H., Davids, P.H., Scholten, P.C., Meij, S. van der, Baal, W.M. van, Dalsen, A.D. van, Lips, D.J., Steeg, J.W. van der, Leclercq, W.K., Geomini, P.M., Consten, E.C., Koops, S.E. Schraffordt, Castro, S.M. de, Kesteren, P.J. van, Cense, H.A., Stockmann, H.B., Cate, A.D. Ten, Bonjer, H.J., Huirne, J.A., and Anema, J.R.

Abstract

Contains fulltext : 215610.pdf (publisher's version ) (Open Access), BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multi

Published
2019

6. Volume of surgery for benign colorectal polyps in the last 11 years

Author

Bronzwaer, Maxime E.S., primary, Koens, Lianne, additional, Bemelman, Willem A., additional, Dekker, Evelien, additional, Fockens, Paul, additional, Beaumont, H., additional, Tuynman, J., additional, de Bruin, G., additional, Van Geloven, A.A.W., additional, Bruins Slot, W., additional, van der Hulst, R.W.M., additional, Vuylsteke, R., additional, Cahen, D., additional, Baan, A.H., additional, Dekkers, P., additional, den Boer, F.C., additional, Depla, A.T.C.M., additional, Bruin, S., additional, Jansen, J.M., additional, Gerhards, M.F., additional, Stokkers, P., additional, van Tets, W.F., additional, Mundt, M.W., additional, van de Ven, A.W.H., additional, Peters, J., additional, Cense, H.A., additional, van der Spek, B.W., additional, Dunker, M.S., additional, van Leerdam, M.E., additional, Aalbers, A.G., additional, Vlug, M., additional, and Sonneveld, D.J.A., additional

Published
2018
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7. Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study

Author

Gorter, R.R., Lee, J.H. van der, Cense, H.A., Kneepkens, C.M., Wijnen, M.H.W.A., Hof, K.H. In 't, Offringa, M., Heij, H.A., Gorter, R.R., Lee, J.H. van der, Cense, H.A., Kneepkens, C.M., Wijnen, M.H.W.A., Hof, K.H. In 't, Offringa, M., and Heij, H.A.

Abstract

Item does not contain fulltext, BACKGROUND: Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults; so far, not much is known about the safety and efficacy of this treatment in children. The aims of this study were to investigate the feasibility of a randomized controlled trial (RCT) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and to evaluate the safety of this approach. METHODS: In a multicenter, prospective cohort study patients aged 7-17 years with a radiologically confirmed simple appendicitis were eligible. Intravenous antibiotics (amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily) were administered for 48-72 hours. Clinical reevaluation every 6 hours, daily blood samples, and ultrasound follow-up after 48 hours was performed. In case of improvement after 48 hours, oral antibiotics were given for a total of 7 days. At any time, in case of clinical deterioration or non-improvement after 72 hours, an appendectomy could be performed. Follow-up continued until 8 weeks after discharge. Adverse events were defined as major complications of antibiotic treatment, such as allergic reactions, perforated appendicitis, and recurrent appendicitis. RESULTS: Of 44 eligible patients, 25 participated (inclusion rate, 57%; 95% CI, 42%-70%). Delayed appendectomy was performed in 2, and the other 23 were without symptoms at the 8 weeks follow-up. Minor complications occurred in three patients. None of the patients suffered from an adverse event or a recurrent appendicitis. CONCLUSION: Our study shows that an RCT comparing initial antibiotic treatment strategy with urgent appendectomy is feasible in children; the intervention seems to be safe.

Published
2015

8. The Ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037)

Author

Swank, H.A., Vermeulen, J., Lange, J.F., Mulder, I.M., Hoeven, J.A.B. van der, Stassen, L.P.S., Crolla, R.M.P.H., Sosef, M.N., Nienhuijs, S.W., Bosker, R.J.I., Boom, M.J., Kruyt, P.M., Swank, D.J., Steup, W.H., Graaf, E.J.R. de, Weidema, W.F., Pierik, R.E.G.J.M., Prins, H.A., Stockmann, H.B.A.C., Tollenaar, R.A.E.M., Wagensveld, B.A. van, Coene, P.P.L.O., Slooter, G.D., Consten, E.C.J., Duijn, E.B. van, Gerhards, M.F., Hoofwijk, A.G.M., Karsten, T.M., Neijenhuis, P.A., Blanken-Peeters, C.F.J.M., Cense, H.A., Mannaerts, G.H.H., Bruin, S.C., Eijsbouts, Q.A.J., Wiezer, M.J., Hazebroek, E.J., Geloven, A.A.W. van, Maring, J.K., D'Hoore, A.J.L., Kartheuser, A., Remue, C., Grevenstein, H.M.U. van, Konsten, J.L.M., Peet, D.L. van der, Govaert, M.J.P.M., Engel, A.F., Reitsma, J.B., Bemelman, W.A., Dutch Diverticular Dis 3D, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Surgery, APH - Amsterdam Public Health, Epidemiology and Data Science, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service de chirurgie et transplantation abdominale, Pediatrics, Radiology & Nuclear Medicine, Nutrition and Movement Sciences, and RS: NUTRIM - R2 - Gut-liver homeostasis

Subjects
Adult, medicine.medical_specialty, Adolescent, medicine.medical_treatment, lcsh:Surgery, Peritonitis, Anastomosis, Diverticulitis - complications, Study Protocol, Sigmoidectomy, Colostomy, medicine, Clinical endpoint, Humans, Peritoneal Lavage, Laparoscopy, Colectomy, Diverticulitis, Aged, Aged, 80 and over, medicine.diagnostic_test, business.industry, General surgery, Peritoneal Lavage - methods, Anastomosis, Surgical, General Medicine, lcsh:RD1-811, Middle Aged, medicine.disease, Surgery, Treatment Outcome, Intestinal Perforation, Peritonitis - etiology, surgery, Female, business, Intestinal Perforation - etiology, surgery
Abstract

Background Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. Discussion The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis. Trial registration Nederlands Trial Register NTR2037

Published
2010
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10. Appendicitis in children: an ongoing debate.

Author

Gorter, R.R., Lee, J.H., Go, P.M.N.Y.H., Wijnen, M.H.W.A., Meijer, R.W., Cense, H.A., Kneepkens, C.M., Heij, H.A., Gorter, R.R., Lee, J.H., Go, P.M.N.Y.H., Wijnen, M.H.W.A., Meijer, R.W., Cense, H.A., Kneepkens, C.M., and Heij, H.A.

Abstract

1 juli 2013, Item does not contain fulltext

Published
2013

11. A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions

Author

Harlaar, J.J. (Joris Jan), Deerenberg, E.B. (Eva), Ramshorst, G.H. (Gabrielle) van, Lont, H.E. (Harold), Borst, E.C.M.H. (Ed) van der, Schouten, W.R. (Willem), Heisterkamp, J. (Joos), Doorn, H.C. (Lena) van, Cense, H.A. (Huib), Berends, F.J. (Frits), Stockmann, H.B.A.C. (Hein), Vrijland, W.W. (Wietske), Consten, E.C. (Esther), Ottow, R.T. (Reyer), Go, P.M.N.Y.H. (Peter), Hermans, J.J. (John), Steyerberg, E.W. (Ewout), Lange, J.F. (Johan), Harlaar, J.J. (Joris Jan), Deerenberg, E.B. (Eva), Ramshorst, G.H. (Gabrielle) van, Lont, H.E. (Harold), Borst, E.C.M.H. (Ed) van der, Schouten, W.R. (Willem), Heisterkamp, J. (Joos), Doorn, H.C. (Lena) van, Cense, H.A. (Huib), Berends, F.J. (Frits), Stockmann, H.B.A.C. (Hein), Vrijland, W.W. (Wietske), Consten, E.C. (Esther), Ottow, R.T. (Reyer), Go, P.M.N.Y.H. (Peter), Hermans, J.J. (John), Steyerberg, E.W. (Ewout), and Lange, J.F. (Johan)

Abstract

Background: The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure. Methods/Design. The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life. A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure. Conclusion: The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or fo

Published
2011
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12. A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions

Author

Harlaar, J.J., Deerenberg, E.B., Ramshorst, G.H. van, Lont, H.E., Borst, E.C. van der, Schouten, W.R., Heisterkamp, J., Doorn, H.C. van, Cense, H.A., Berends, F., Stockmann, H.B., Vrijland, W.W., Consten, E.C., Ottow, R.T., Go, P.M.N.Y.H., Hermans, J.J., Steyerberg, E.W., Lange, J.F., Harlaar, J.J., Deerenberg, E.B., Ramshorst, G.H. van, Lont, H.E., Borst, E.C. van der, Schouten, W.R., Heisterkamp, J., Doorn, H.C. van, Cense, H.A., Berends, F., Stockmann, H.B., Vrijland, W.W., Consten, E.C., Ottow, R.T., Go, P.M.N.Y.H., Hermans, J.J., Steyerberg, E.W., and Lange, J.F.

Abstract

Contains fulltext : 95575.pdf (publisher's version ) (Open Access), BACKGROUND: The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure. METHODS/DESIGN: The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life. A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure. CONCLUSION: The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or fo

Published
2011

13. The ladies trial: Laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037)

Author

Swank, D.J. (Dingeman), Vermeulen, J. (Jefrey), Lange, J.F. (Johan), Mulder, I.M. (Irene), Hoeven, J.A.B. (Joost) van der, Stassen, L.P. (Laurents), Crolla, R.M.P.H. (Rogier), Sosef, M.N. (Meindert), Nienhuijs, S.W. (Simon), Bosker, R.J.I. (Robbert), Boom, M.J. (Maarten), Kruyt, Ph.M. (Philip), Steup, W.H. (Willem Hans), Graaf, E.J.R. (Eelco) de, Weidema, W.F. (Wibo), Pierik, R.E.G.J.M. (Robert), Prins, H.A. (Hubert), Stockmann, H.B.A.C., Tollenaar, R.A.E.M. (Rob), Wagensveld, B.A. (Bart) van, Coene, P-P. (Peter Paul), Slooter, G.D. (Gerrit), Consten, E.C. (Esther), Duijn, E.B. (Eino) van, Gerhards, M.F. (Michael), Hoofwijk, A.G.M. (Anton), Karsten, T.M. (Thomas), Neijenhuis, P.A. (Peter), Blanken-Peeters, C.F.J.M. (Charlotte), Cense, H.A. (Huib), Mannaerts, G.H.H. (Guido), Bruin, S.C. (Sjoerd), Eijsbouts, Q.A. (Quirijn), Wiezer, M.J. (Marinus), Hazebroek, E.J. (Eric Jasper), Geloven, A.A. (Anna) van, Maring, J.K. (John), D'Hoore, A. (André), Kartheuser, A. (Alex), Remue, C. (Christophe), Grevenstein, H.M.U. (Helma) van, Konsten, J.L.M. (Joop), Peet, D.L. (Donald) van der, Govaert, M.J.P.M. (Marc), Engel, A.F. (Alexander), Reitsma, J.B. (Johannes), Bemelman, W.A. (Willem), Swank, D.J. (Dingeman), Vermeulen, J. (Jefrey), Lange, J.F. (Johan), Mulder, I.M. (Irene), Hoeven, J.A.B. (Joost) van der, Stassen, L.P. (Laurents), Crolla, R.M.P.H. (Rogier), Sosef, M.N. (Meindert), Nienhuijs, S.W. (Simon), Bosker, R.J.I. (Robbert), Boom, M.J. (Maarten), Kruyt, Ph.M. (Philip), Steup, W.H. (Willem Hans), Graaf, E.J.R. (Eelco) de, Weidema, W.F. (Wibo), Pierik, R.E.G.J.M. (Robert), Prins, H.A. (Hubert), Stockmann, H.B.A.C., Tollenaar, R.A.E.M. (Rob), Wagensveld, B.A. (Bart) van, Coene, P-P. (Peter Paul), Slooter, G.D. (Gerrit), Consten, E.C. (Esther), Duijn, E.B. (Eino) van, Gerhards, M.F. (Michael), Hoofwijk, A.G.M. (Anton), Karsten, T.M. (Thomas), Neijenhuis, P.A. (Peter), Blanken-Peeters, C.F.J.M. (Charlotte), Cense, H.A. (Huib), Mannaerts, G.H.H. (Guido), Bruin, S.C. (Sjoerd), Eijsbouts, Q.A. (Quirijn), Wiezer, M.J. (Marinus), Hazebroek, E.J. (Eric Jasper), Geloven, A.A. (Anna) van, Maring, J.K. (John), D'Hoore, A. (André), Kartheuser, A. (Alex), Remue, C. (Christophe), Grevenstein, H.M.U. (Helma) van, Konsten, J.L.M. (Joop), Peet, D.L. (Donald) van der, Govaert, M.J.P.M. (Marc), Engel, A.F. (Alexander), Reitsma, J.B. (Johannes), and Bemelman, W.A. (Willem)

Abstract

Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power

Published
2010
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14. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial)

Author

Ünlü, C.̧., Korte, N. (Niels) de, Daniels, L. (Lidewine), Consten, E.C. (Esther), Cuesta, M.A. (Miguel), Gerhards, M.F. (Michael), Geloven, A.A. (Anna) van, Zaag, E.S. (Edwin) van der, Hoeven, J.A.B. (Joost) van der, Klicks, R. (Rutger), Cense, H.A. (Huib), Roumen, R.M. (Rudi), Eijsbouts, Q.A. (Quirijn), Lange, J.F. (Johan), Fockens, P. (Paul), Borgie, C.A. (Corianne) de, Bemelman, W.A. (Willem), Reitsma, J.B. (Johannes), Stockmann, H.B.A.C., Vrouenraets, B.C. (Bart), Boermeester, M.A. (Marja), Ünlü, C.̧., Korte, N. (Niels) de, Daniels, L. (Lidewine), Consten, E.C. (Esther), Cuesta, M.A. (Miguel), Gerhards, M.F. (Michael), Geloven, A.A. (Anna) van, Zaag, E.S. (Edwin) van der, Hoeven, J.A.B. (Joost) van der, Klicks, R. (Rutger), Cense, H.A. (Huib), Roumen, R.M. (Rudi), Eijsbouts, Q.A. (Quirijn), Lange, J.F. (Johan), Fockens, P. (Paul), Borgie, C.A. (Corianne) de, Bemelman, W.A. (Willem), Reitsma, J.B. (Johannes), Stockmann, H.B.A.C., Vrouenraets, B.C. (Bart), and Boermeester, M.A. (Marja)

Abstract

Background. Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods. A randomized multicenter pragmatic clinical trial comparing

Published
2010
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15. Direct trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A Multicenter randomised clinical trial

Author

Wall, B.J.M. (Bryan) van de, Draaisma, W.A. (Werner), Consten, E.C. (Esther), Graaf, Y. (Yolanda) van der, Otten, M.H. (Marten Henk), Wit, G.A. (Ardine) de, Stel, H.F. (Henk) van, Gerhards, M.F. (Michael), Wiezer, M.J. (Marinus), Cense, H.A. (Huib), Stockmann, H.B.A.C. (Hein), Leijtens, J.W.A. (Jeroen), Zimmerman, D.D.E. (David), Belgers, E.H.J. (Eric), Wagensveld, B.A. (Bart) van, Sonneveld, E.D.J.A. (Eric), Prins, H.A. (Hubert), Coene, P-P. (Peter Paul), Karsten, T.M. (Thomas), Klaase, J.M. (Joost), Statius Muller, M.G. (Markwin), Crolla, R.M.P.H. (Rogier), Broeders, I.A.M.J. (Ivo), Wall, B.J.M. (Bryan) van de, Draaisma, W.A. (Werner), Consten, E.C. (Esther), Graaf, Y. (Yolanda) van der, Otten, M.H. (Marten Henk), Wit, G.A. (Ardine) de, Stel, H.F. (Henk) van, Gerhards, M.F. (Michael), Wiezer, M.J. (Marinus), Cense, H.A. (Huib), Stockmann, H.B.A.C. (Hein), Leijtens, J.W.A. (Jeroen), Zimmerman, D.D.E. (David), Belgers, E.H.J. (Eric), Wagensveld, B.A. (Bart) van, Sonneveld, E.D.J.A. (Eric), Prins, H.A. (Hubert), Coene, P-P. (Peter Paul), Karsten, T.M. (Thomas), Klaase, J.M. (Joost), Statius Muller, M.G. (Markwin), Crolla, R.M.P.H. (Rogier), and Broeders, I.A.M.J. (Ivo)

Abstract

Background: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design: The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up

Published
2010
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16. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial).

Author

Eshuis, E.J.H.M., Bemelman, W.A., Bodegraven, A.A, Sprangers, M.A.G., Bossuyt, P.M., Milligen de Wit, A.W. van, Crolla, R.M., Cahen, D.H., Oostenbrug, L.E., Sosef, M.N., Voorburg, A.M., Davids, P.H., Woude, C.J. van der, Lange, J. de, Mallant, R.C., Boom, M.J., Lieverse, R.J., Zaag, E.S. van der, Houben, M.H., Vecht, J., Pierik, R.E., Ditzhuijsen, T.J. van, Prins, H.A., Marsman, W.A., Stockmann, H.B., Brink, M., Consten, E.C., Werf, S.D. van der, Marinelli, A.W., Jansen, J.M., Gerhards, M.F., Bolwerk, C.J., Stassen, L.P., Spanier, B.W., Bilgen, E.J., Berkel, A.M. van, Cense, H.A., Heukelem, H.A. van, Laar, A. van t, Slot, W.B., Eijsbouts, Q.A., Ooteghem, N.A. van, Wagensveld, B.A. van, Brande, J.M. van den, Geloven, A.A. van, Bruin, K.F., Maring, J.K., Oldenburg, B., Hillegersberg, R. van, Jong, D. de, Bleichrodt, R.P., Peet, D.L. van der, Dekkers, P.E., Goei, T.H., Stokkers, P.C., Eshuis, E.J.H.M., Bemelman, W.A., Bodegraven, A.A, Sprangers, M.A.G., Bossuyt, P.M., Milligen de Wit, A.W. van, Crolla, R.M., Cahen, D.H., Oostenbrug, L.E., Sosef, M.N., Voorburg, A.M., Davids, P.H., Woude, C.J. van der, Lange, J. de, Mallant, R.C., Boom, M.J., Lieverse, R.J., Zaag, E.S. van der, Houben, M.H., Vecht, J., Pierik, R.E., Ditzhuijsen, T.J. van, Prins, H.A., Marsman, W.A., Stockmann, H.B., Brink, M., Consten, E.C., Werf, S.D. van der, Marinelli, A.W., Jansen, J.M., Gerhards, M.F., Bolwerk, C.J., Stassen, L.P., Spanier, B.W., Bilgen, E.J., Berkel, A.M. van, Cense, H.A., Heukelem, H.A. van, Laar, A. van t, Slot, W.B., Eijsbouts, Q.A., Ooteghem, N.A. van, Wagensveld, B.A. van, Brande, J.M. van den, Geloven, A.A. van, Bruin, K.F., Maring, J.K., Oldenburg, B., Hillegersberg, R. van, Jong, D. de, Bleichrodt, R.P., Peet, D.L. van der, Dekkers, P.E., Goei, T.H., and Stokkers, P.C.

Abstract

Contains fulltext : 69534.pdf (publisher's version ) (Open Access), BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is th

Published
2008

17. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: A randomized multicenter trial (LIR!C-trial)

Author

Eshuis, E.J. (Emma), Bemelman, W.A. (Willem), Bodegraven, A.A. (Ad) van, Sprangers, M.A.G. (Mirjam), Bossuyt, P.M.M. (Patrick), Wit, A.W.M.V.M. de, Crolla, R.M.P.H. (Rogier), Cahen, D.L. (Djuna), Oostenbrug, L.E. (Liekele), Sosef, M.N. (Meindert), Voorburg, A.M.C.J. (Annet), Davids, P.H.P. (Paul), Woude, C.J. (Janneke) van der, Lange, J.F. (Johan), Mallant, R.C. (Rosalie), Boom, M.J. (Maarten), Lieverse, R.J. (Rob), Zaag, E.S. (Edwin) van der, Houben, M.H.M.G. (Martin), Vecht, C.J., Pierik, R.E.G.J.M. (Robert), Ditzhuijsen, T.J.M. (Theo) van, Prins, H.A. (Hubert), Marsman, W.A. (Willem), Stockmann, H.B. (Henricus), Brink, M.A. (Menno), Consten, E.C. (Esther), Werf, S.D.J. (Sjoerd) van der, Marinelli, A.W. (Andreas), Jansen, J.M. (Jeroen Michiel), Gerhards, M.F. (Michael), Bolwerk, C.L. (Clemens), Stassen, L.P. (Laurents), Spanier, B.W.M. (Marcel), Bilgen, E.J.S., Berkel, A.-M. (Anne-Marie) van, Cense, H.A. (Huib), Heukelem, H.A. (Henk) van, Laar, A. (Arnold) van de, Slot, W.B., Eijsbouts, Q.A. (Quirijn), Ooteghem, N.A. (Nancy), Wagensveld, B.A. (Bart) van, Brande, J.M.H. (Jan) van den, Geloven, A.A. (Anna) van, Bruin, K.F. (Karien), Maring, J.K. (John), Oldenburg, B. (Bas), Hillegersberg, R. (Richard) van, Jong, D.J. (Dirk) de, Bleichrodt, R. (Robert), Peet, D.L. (Donald) van der, Dekkers, P.E.P. (Pascal), Goei, T.H. (Hauwy), Stokkers, P.C.F. (Pieter), Eshuis, E.J. (Emma), Bemelman, W.A. (Willem), Bodegraven, A.A. (Ad) van, Sprangers, M.A.G. (Mirjam), Bossuyt, P.M.M. (Patrick), Wit, A.W.M.V.M. de, Crolla, R.M.P.H. (Rogier), Cahen, D.L. (Djuna), Oostenbrug, L.E. (Liekele), Sosef, M.N. (Meindert), Voorburg, A.M.C.J. (Annet), Davids, P.H.P. (Paul), Woude, C.J. (Janneke) van der, Lange, J.F. (Johan), Mallant, R.C. (Rosalie), Boom, M.J. (Maarten), Lieverse, R.J. (Rob), Zaag, E.S. (Edwin) van der, Houben, M.H.M.G. (Martin), Vecht, C.J., Pierik, R.E.G.J.M. (Robert), Ditzhuijsen, T.J.M. (Theo) van, Prins, H.A. (Hubert), Marsman, W.A. (Willem), Stockmann, H.B. (Henricus), Brink, M.A. (Menno), Consten, E.C. (Esther), Werf, S.D.J. (Sjoerd) van der, Marinelli, A.W. (Andreas), Jansen, J.M. (Jeroen Michiel), Gerhards, M.F. (Michael), Bolwerk, C.L. (Clemens), Stassen, L.P. (Laurents), Spanier, B.W.M. (Marcel), Bilgen, E.J.S., Berkel, A.-M. (Anne-Marie) van, Cense, H.A. (Huib), Heukelem, H.A. (Henk) van, Laar, A. (Arnold) van de, Slot, W.B., Eijsbouts, Q.A. (Quirijn), Ooteghem, N.A. (Nancy), Wagensveld, B.A. (Bart) van, Brande, J.M.H. (Jan) van den, Geloven, A.A. (Anna) van, Bruin, K.F. (Karien), Maring, J.K. (John), Oldenburg, B. (Bas), Hillegersberg, R. (Richard) van, Jong, D.J. (Dirk) de, Bleichrodt, R. (Robert), Peet, D.L. (Donald) van der, Dekkers, P.E.P. (Pascal), Goei, T.H. (Hauwy), and Stokkers, P.C.F. (Pieter)

Abstract

Background. With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to co

Published
2008
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20. Molecular evidence of field cancerization in a patient with 7 tumors of the aerodigestive tract

Author

van Rees, B.P., Cleton-Jansen, A.M., Cense, H.A., Polak, M.M., Clement, M.J., Drillenburg, P., van Lanschot, J.J.B., and Offerhaus, G.J.A.

Abstract

Exposure of the mucosa of the upper aerodigestive tract to carcinogens can induce genetic changes resulting in various independent clones of neoplastic growth, a concept defined as ''field cancerization.'' The risk of developing multiple tumors in this compartment of the body is well established. We studied 6 distinct tumors of the upper aerodigestive tract of a single patient for loss of heterozygosity (LOH), microsatellite instability (MSI), p53 mutations, and K-ras codon 12 point mutations. We detected a unique pattern of LOH and p53 mutations in all 6 tumors. No tumor showed a K-ras mutation or MSI. The results support the mechanism of ''field cancerization'' and illustrate the potential power of molecular techniques to elucidate pathogenesis.

Published
2000
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