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5 results on '"Kruyt, P.M."'

1. Cross-Sectional Study on MRI Restaging After Chemoradiotherapy and Interval to Surgery in Rectal Cancer: Influence on Short- and Long-Term Outcomes

Author

Detering, R., Borstlap, W.A.A., Broeders, L., Hermus, L., Marijnen, C.A.M., Beets-Tan, R.G.H., Bemelman, W.A., Westreenen, H.L. van, Tanis, P.J., Aalbers, A., Acherman, Y., Algie, G.D., Geusau, B.A. von, Amelung, F., Bartels, S.A., Basha, S., Bastiaansen, A.J.N.M., Belgers, E., Bleeker, W., Blok, J., Bosker, R.J.I., Bosmans, J.W., Boute, M.C., Bouvy, N.D., Bouwman, H., Brandt-Kerkhof, A., Brinkman, D.J., Bruin, S., Bruns, E.R.J., Burbach, J.P.M., Burger, J.W.A., Buskens, C.J., Clermonts, S., Coene, P.P.L.O., Compaan, C., Consten, E.C.J., Darbyshire, T., Mik, S.M.L. de, Graaf, E.J.R. de, Groot, I. de, Cappel, R.J.L.D.T.N., Wilt, J.H.W. de, Wolde, J. van der, Boer, F.C. den, Dekker, J.W.T., Demirkiran, A., Derkx-Hendriksen, M., Dijkstra, F.R., Duijvendijk, P. van, Dunker, M.S., Eijsbouts, Q.E., Fabry, H., Ferenschild, F., Foppen, J.W., Gerhards, M.F., Gerven, P., Gooszen, J.A.H., Govaert, J.A., Grevenstein, W.M.U. van, Haen, R., Harlaar, J.J., Harst, E., Havenga, K., Heemskerk, J., Heeren, J.F., Heijnen, B., Heres, P., Hoff, C., Hogendoorn, W., Hoogland, P., Huijbers, A., Janssen, P., Jongen, A.C., Jonker, F.H., Karthaus, E.G., Keijzer, A., Ketel, J.M.A., Klaase, J., Wit, F., Kloppenberg, H., Kool, M.E., Kortekaas, R., Kruyt, P.M., Kuiper, J.T., Lamme, B., Lange, J.F., Lettinga, T., Lips, D.J., Logeman, F., Holzik, M.F.L., Madsen, E., Mamound, A., Marres, C.C., Masselink, I., Meerdink, M., Menon, A.G., Mieog, J.S., Mierlo, D., Musters, G.D., Nieuwenhuijzen, G.A.P., Neijenhuis, P.A., Nonner, J., Oostdijk, M., Paul, P.M.P., Peeters, K.C.M.J., Pereboom, I.T.A., Polat, F., Poortman, P., Raber, M., Reiber, B.M.M., Renger, R.J., Rossem, C.C. van, Rutten, H.J., Rutten, A., Schaapman, R., Scheer, M., Schoonderwoerd, L., Schouten, N., Schreuder, A.M., Schreurs, W.H., Simkens, G.A., Slooter, G.D., Sluijmer, H.C.E., Smakman, N., Smeenk, R., Snijders, H.S., Sonneveld, D.J.A., Spaansen, B., Bilgen, E.J.S., Steller, E., Steup, W.H., Steur, C., Stortelder, E., Straatman, J., Swank, H.A., Sietses, C., Berge, H.A. ten, Hoeve, H.G. ten, Riele, W.W. ter, Thorensen, I.M., Tip-Pluijm, B., Toorenvliet, B.R., Tseng, L., Tuynman, J.B., Bastelaar, J. van, Beek, S.C. van, Ven, A.W.H. van de, Weijer, M.A.J. van de, Berg, C. van den, Bosch, I. van den, Bilt, J.D.W. van der, Hagen, S.J. van der, Hul, R. van der, Schelling, G. van der, Spek, A. van der, Wielen, N. van der, Duyn, E. van, Eekelen, C. van, Essen, J.A. van, Gangelt, K. van, Geloven, A.A.W. van, Kessel, C. van, Loon, Y.T. van, Rijswijk, A. van, Rooijen, S.J. van, Sprundel, T. van, Steensel, L. van, Tets, W.F. van, Veltkamp, S., Verhaak, T., Verheijen, P.M., Versluis-Ossenwaarde, L., Vijfhuize, S., Vles, W.J., Voeten, S.C., Vogelaar, F.J., Vrijland, W.W., Westerduin, E., Westerterp, M.E., Wetzel, M., Wevers, K.P., Wiering, B., Witjes, C.D.M., Wouters, M.W., Yauw, S.T.K., Zaag, E.S. van der, Zeestraten, E.C., Zimmerman, D.D., Zwieten, T., Dutch Snapshot Res Grp, Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), CCA - Cancer Treatment and quality of life, Surgery, Amsterdam Reproduction & Development (AR&D), and Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Male, IMPACT, medicine.medical_treatment, THERAPY, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], CHEMORADIATION, 0302 clinical medicine, ADJUVANT CHEMOTHERAPY, Interquartile range, Medicine, PATHOLOGICAL COMPLETE RESPONSE, Stage (cooking), Neoadjuvant therapy, Netherlands, Aged, 80 and over, medicine.diagnostic_test, Incidence, ASO Author Reflections, Chemoradiotherapy, Middle Aged, Magnetic Resonance Imaging, Neoadjuvant Therapy, Survival Rate, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Surgical Procedures, Operative, SURVIVAL, 030211 gastroenterology & hepatology, Female, TIME-INTERVAL, RADIOTHERAPY, medicine.medical_specialty, RESECTION, Preoperative care, Time-to-Treatment, 03 medical and health sciences, Preoperative Care, Humans, Survival rate, Aged, Neoplasm Staging, Retrospective Studies, business.industry, Rectal Neoplasms, Magnetic resonance imaging, Retrospective cohort study, NEOADJUVANT CHEMORADIOTHERAPY, Surgery, Cross-Sectional Studies, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

Contains fulltext : 215772.pdf (Publisher’s version ) (Open Access) BACKGROUND: The time interval between CRT and surgery in rectal cancer patients is still the subject of debate. The aim of this study was to first evaluate the nationwide use of restaging magnetic resonance imaging (MRI) and its impact on timing of surgery, and, second, to evaluate the impact of timing of surgery after chemoradiotherapy (CRT) on short- and long-term outcomes. METHODS: Patients were selected from a collaborative rectal cancer research project including 71 Dutch centres, and were subdivided into two groups according to time interval from the start of preoperative CRT to surgery (< 14 and >/= 14 weeks). RESULTS: From 2095 registered patients, 475 patients received preoperative CRT. MRI restaging was performed in 79.4% of patients, with a median CRT-MRI interval of 10 weeks (interquartile range [IQR] 8-11) and a median MRI-surgery interval of 4 weeks (IQR 2-5). The CRT-surgery interval groups consisted of 224 (< 14 weeks) and 251 patients (>/= 14 weeks), and the long-interval group included a higher proportion of cT4 stage and multivisceral resection patients. Pathological complete response rate (n = 34 [15.2%] vs. n = 47 [18.7%], p = 0.305) and CRM involvement (9.7% vs. 15.9%, p = 0.145) did not significantly differ. Thirty-day surgical complications were similar (20.1% vs. 23.1%, p = 0.943), however no significant differences were found for local and distant recurrence rates, disease-free survival, and overall survival. CONCLUSIONS: These real-life data, reflecting routine daily practice in The Netherlands, showed substantial variability in the use and timing of restaging MRI after preoperative CRT for rectal cancer, as well as time interval to surgery. Surgery before or after 14 weeks from the start of CRT resulted in similar short- and long-term outcomes.

Published
2019

2. Benchmarking recent national practice in rectal cancer treatment with landmark randomized controlled trials

Author

Borstlap, W.A., Deijen, C.L., Dulk, M. den, Bonjer, H.J., Velde, C.J. van de, Bemelman, W.A., Tanis, P.J., Aalbers, A., Acherman, Y., Algie, G.D., Geu-sau, B. von, Amelung, F., Aukema, T.S., Bakker, I.S., Bartels, S.A., Basha, S., Bastiaansen, A.J., Belgers, E.H.J., Bleeker, W., Blok, J., Bosker, R.J.I., Bosmans, J.W., Boute, M.C., Bouvy, N.D., Bouwman, H., Brandt-Kerkhof, A., Brinkman, D.J., Bruin, S., Bruns, E.R.J., Burbach, J.P.M., Burger, J.W., Buskens, C.J., Clermonts, S., Coene, P.P.L.O., Compaan, C., Consten, E.C., Darbyshire, T., Mik, S.M.L. de, Graaf, E.J. de, Groot, I de, Cappel de Vos Tot Nederveen, R.J.L., Wilt, J.H.W. de, Wolde, J. van der, Boer, F.C. den, Dekker, J.W.T., Demirkiran, A., Derkx-Hendriksen, M., Dijkstra, F.R., Duijvendijk, P. van, Dunker, M.S., Eijsbouts, Q.E., Fabry, H., Ferenschild, F.T.J., Foppen, J.W., Furnee, E.J.B., Gerhards, M.F., Gerven, P, Gooszen, J.A.H., Govaert, J.A., Grevenstein, W.M. van, Haen, R., Harlaar, J.J., Harst, E, Havenga, K., Heemskerk, J., Heeren, J.F., Heijnen, B., Heres, P., Hoff, C., Hogendoorn, W., Hoogland, P., Huijbers, A, Janssen, P., Jongen, A.C., Jonker, F.H., Karthaus, E.G., Keijzer, A, Ketel, J.M.A., Klaase, J., Kloppenberg, F.W.H., Kool, M.E., Kortekaas, R., Kruyt, P.M., Kuiper, J.T., Lamme, B., Lange, J.F., Lettinga, T., Lips, D.J., Logeman, F., Holzik, M.F., Madsen, E., Mamound, A., Marres, C.C., Masselink, I., Meerdink, M., Menon, A.G., Mieog, J.S., Mierlo, D. van, Musters, G.D., Neijenhuis, P.A., Nonner, J., Oostdijk, M, Oosterling, S.J., Paul, P.M.P., Peeters, K.C., Pereboom, I.T.A., Polat, F., Poortman, P., Raber, M., Reiber, B.M.M., Renger, R.J., Rossem, C.C. van, Rutten, H.J., Rutten, A., Schaapman, R., Scheer, M.G.W., Schoonderwoerd, L., Schouten, N., Schreuder, A.M., Schreurs, W.H., Simkens, G.A., Slooter, G.D., Sluijmer, H.C.E., Smakman, N., Smeenk, R., Snijders, H.S., Sonneveld, D.J.A., Spaansen, B., Spillenaar Bilgen, E.J., Steller, E., Steup, W.H., Steur, C., Stortelder, E., Straatman, J., Swank, H.A., Sietses, C., Berge, H.A. ten, Hoeve, H.G. ten, Riele, W.W. ter, Thorensen, I.M., Tip-Pluijm, B., Toorenvliet, B.R., Tseng, L., Tuynman, J.B., Bastelaar, J. van, Beek, S.V. van, Ven, A.W.H. van de, Weijer, M.A.J. van de, Berg, C. van den, Bosch, I. van den, Bilt, J.D.W. van der, Hagen, S.J. van der, Hul, R. van der, Schelling, G.P. van der, Spek, A van der, Wielen, N. van der, Duyn, E. van, Eekelen, C. van, Essen, J.A. van, Gangelt, K. van, Geloven, A.A. van, Kessel, C. Van, Loon, Y.T. van, Rijswijk, A. van, Rooijen, S.J. van, Sprundel, T. van, Steensel, L. van, Tets, W.F van, Westreenen, H.L. van, Veltkamp, S., Verhaak, T., Verheijen, P.M., Versluis-Ossenwaarde, L., Vijfhuize, S., Vles, W.J., Voeten, S., Vogelaar, F.J., Vrijland, W.W., Westerduin, E., Westerterp, M., Wetzel, M., Wevers, K., Wiering, B., Witjes, A.C., Wouters, M.W., Yauw, S.T.K., Zeestraten, E.C., Zimmerman, D., Zwieten, T., Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), Surgery, CCA - Cancer Treatment and quality of life, APH - Quality of Care, APH - Global Health, Anatomy and neurosciences, VU University medical center, AGEM - Re-generation and cancer of the digestive system, AGEM - Digestive immunity, Neurology, Internal medicine, ACS - Microcirculation, MUMC+: MA Heelkunde (9), RS: MHeNs - R2 - Mental Health, Psychiatrie & Neuropsychologie, Promovendi MHN, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, RS: NUTRIM - R1 - Metabolic Syndrome, RS: NUTRIM - R2 - Liver and digestive health, Revalidatie, RS: CARIM - R1.03 - Cell biochemistry of thrombosis and haemostasis, Biochemie, Promovendi CD, Ondersteunend personeel NTM, Promovendi NTM, Promovendi PHPC, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA AIOS Heelkunde (9), Promovendi ODB, MUMC+: MA AIOS Anesthesiologie (9), Pathologie, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA - Cancer Treatment and Quality of Life, Graduate School, and Other departments

Subjects
Male, Transanal Endoscopic Microsurgery, Colorectal cancer, medicine.medical_treatment, NETHERLANDS, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, ADJUVANT CHEMOTHERAPY, Randomized controlled trial, law, Interquartile range, Prospective Studies, Registries, Rectal cancer, Intersectoral Collaboration, Randomized Controlled Trials as Topic, Aged, 80 and over, Medical Audit, Gastroenterology, Margins of Excision, Chemoradiotherapy, Benchmarking, Middle Aged, Total mesorectal excision, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, snapshot study, 030220 oncology & carcinogenesis, OPEN SURGERY, Cohort, Female, 030211 gastroenterology & hepatology, RADIOTHERAPY, medicine.medical_specialty, Disease-Free Survival, 03 medical and health sciences, ANTERIOR RESECTION, medicine, Humans, Aged, Retrospective Studies, oncologic outcomes, Rectal Neoplasms, business.industry, General surgery, TOTAL MESORECTAL EXCISION, medicine.disease, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Radiation therapy, Cross-Sectional Studies, Circumferential resection margin, Neoplasm Recurrence, Local, business
Abstract

Aim A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark.Method In this collaborative research project, the dataset of the Dutch Surgical Colorectal Audit was extended with additional treatment and long-term outcome data. All registered patients who underwent resection for rectal cancer in 2011 were eligible. Baseline characteristics and outcome were evaluated against the results of the Dutch TME trial and the COLOR II trial from which the original datasets were obtained.Results A total of 71 hospitals participated, and data were completed for 2102 out of the potential 2633 patients (79.8%). Median follow-up was 41 (interquartile range 25-47) months. Overall circumferential resection margin (CRM) involvement was 9.3% in the Snapshot cohort and 18.5% in the Dutch TME trial. CRM positivity after laparoscopic resection was 7.8% in the Snapshot and 9.5% in the COLOR II trial. Three-year overall local recurrence rate in the Snapshot was 5.9%, with a disease-free survival of 67.1% and overall survival of 79.5%. Benchmarking with the randomized controlled trials revealed an overall favourable long-term outcome of the Snapshot cohort.Conclusion This study showed that current rectal cancer care in a large unselected Dutch population is of high quality, with less positive CRM since the TME trial and oncologically safe implementation of minimally invasive surgery after the COLOR II trial.

Published
2017

3. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial)

Author

Bouwense, S.A.W., Besselink, M.G., Brunschot, S. van, Bakker, O.J., Santvoort, H.C. van, Schepers, N.J., Boermeester, M.A., Bollen, T.L., Bosscha, K., Brink, M.A., Bruno, M.J., Consten, E.C., Dejong, C.H., Duijvendijk, P. van, Eijck, C.H. van, Gerritsen, J.J., Goor, H. van, Heisterkamp, J., Hingh, I.H.J.T. de, Kruyt, P.M., Molenaar, I.Q., Nieuwenhuijs, V.B., Rosman, C., Schaapherder, A.F., Scheepers, J.J., Spanier, M.B., Timmer, R., Weusten, B.L., Witteman, B.J., van Ramshorst, B., Gooszen, H.G., Boerma, D., for the Dutch Pancreatitis Study, G., Verbeek, A.L., Surgery, Graduate School, AII - Amsterdam institute for Infection and Immunity, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Other departments, Gastroenterology and Hepatology, Gastroenterology & Hepatology, and RS: NUTRIM - R2 - Gut-liver homeostasis

Subjects
Time Factors, medicine.medical_treatment, Medicine (miscellaneous), Gallstones, GUIDELINES, Trial, Study Protocol, CONSERVATIVE TREATMENT, GALLSTONE PANCREATITIS, Evaluation of complex medical interventions Aetiology, screening and detection [NCEBP 2], Clinical endpoint, Secondary Prevention, Cholecystitis, Pharmacology (medical), LAPAROSCOPIC CHOLECYSTECTOMY, Netherlands, First episode, lcsh:R5-920, Endoscopic retrograde cholangiopancreatography, medicine.diagnostic_test, Health Care Costs, Treatment Outcome, Cholecystectomy, Laparoscopic, Research Design, ACID, Acute pancreatitis, Evaluation of complex medical interventions Tissue engineering and pathology [NCEBP 2], lcsh:Medicine (General), medicine.medical_specialty, Common bile duct, Patient Readmission, Time-to-Treatment, medicine, Humans, Cholecystectomy, Timing, Mortality, business.industry, General surgery, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, medicine.disease, Surgery, Endoscopic retrograde cholangiopancreaticography, Pancreatitis, SPHINCTEROTOMY, Evaluation of complex medical interventions [NCEBP 2], business
Abstract

Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis. Trial registration Current Controlled Trials: ISRCTN72764151

Published
2012

4. A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome

Author

Santvoort, H.C. van, Bakker, O.J., Bollen, T.L., Besselink, M.G., Ali, U.A., Schrijver, A.M., Boermeester, M.A., Goor, H. van, Dejong, C.H., Eijck, C.H. van, Ramshorst, B. van, Schaapherder, A.F., Harst, E. van der, Hofker, S., Nieuwenhuijs, V.B., Brink, M.A., Kruyt, P.M., Manusama, E.R., Schelling, G.P. van der, Karsten, T., Hesselink, E.J., Laarhoven, C.J. van, Rosman, C., Bosscha, K., Wit, R.J. de, Houdijk, A.P., Cuesta, M.A., Wahab, P.J., Gooszen, H.G., Dutch Pancreatitis Study Grp, Surgery, CCA - Innovative therapy, RS: NUTRIM - R2 - Gut-liver homeostasis, Graduate School, AII - Amsterdam institute for Infection and Immunity, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Radiology and Nuclear Medicine, Other departments, CCA -Cancer Center Amsterdam, and Gastroenterology and Hepatology

Subjects
Male, Time Factors, Abdominal compartment syndrome, medicine.medical_treatment, Single Center, GUIDELINES, Severity of Illness Index, Interquartile range, Risk Factors, Laparotomy, Odds Ratio, Prospective Studies, Prospective cohort study, Netherlands, Randomized Controlled Trials as Topic, APACHE II, Nutritional Support, Pancreatitis, Acute Necrotizing, NECROSIS, Gastroenterology, Middle Aged, NECROSECTOMY, Clinical Trial, Anti-Bacterial Agents, Treatment Outcome, SURGICAL-MANAGEMENT, Drainage, Female, ABDOMINAL COMPARTMENT SYNDROME, ORGAN FAILURE, Adult, medicine.medical_specialty, Multiple Organ Failure, Risk Assessment, Catheterization, RETROPERITONEAL APPROACH, Pancreatectomy, Severity of illness, medicine, Humans, Molecular gastro-enterology and hepatology [IGMD 2], Pancreas, Aged, Inflammation, Chi-Square Distribution, Hepatology, business.industry, Patient Selection, MORTALITY, Endoscopy, medicine.disease, Surgery, Treatment, Logistic Models, Debridement, Evaluation of complex medical interventions [NCEBP 2], Linear Models, Pancreatitis, EXPERIENCE, Emergencies, business, Tomography, X-Ray Computed, SINGLE-CENTER
Abstract

BACKGROUND & AIMS: Treatment of patients with necrotizing pancreatitis has become more conservative and less invasive, but there are few data from prospective studies to support the efficacy of this change. We performed a prospective multicenter study of treatment outcomes among patients with necrotizing pancreatitis. METHODS: We collected data from 639 consecutive patients with necrotizing pancreatitis, from 2004 to 2008, treated at 21 Dutch hospitals. Data were analyzed for disease severity, interventions (radiologic, endoscopic, surgical), and outcome. RESULTS: Overall mortality was 15% (n = 93). Organ failure occurred in 240 patients (38%), with 35% mortality. Treatment was conservative in 397 patients (62%), with 7% mortality. An intervention was performed in 242 patients (38%), with 27% mortality; this included early emergency laparotomy in 32 patients (5%), with 78% mortality. Patients with longer times between admission and intervention had lower mortality: 0 to 14 days, 56%; 14 to 29 days, 26%; and >29 days, 15% (P

Published
2011

5. 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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