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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
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2. Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial

Author

Breugom, A.J., Gijn, W. van, Muller, E.W., Berglund, A., Broek, C.B.M. van den, Fokstuen, T., Gelderblom, H., Kapiteijn, E., Leer, J.W.H., Marijnen, C.A.M., Martijn, H., Kranenbarg, E.M.K., Nagtegaal, I.D., Pahlman, L., Punt, C.J.A., Putter, H., Roodvoets, A.G.H., Rutten, H.J.T., Steup, W.H., Glimelius, B., Velde, C.J.H. van de, Dutch Colorectal Canc Grp, Nordic Gastrointestinal Tumour Adj, CCA -Cancer Center Amsterdam, Oncology, Surgery, RS: GROW - Oncology, and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy

Subjects
Male, rectal adenocarcinoma, medicine.medical_specialty, Colorectal cancer, preoperative radiotherapy, medicine.medical_treatment, Leucovorin, Adenocarcinoma, Preoperative care, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Antineoplastic Combined Chemotherapy Protocols, medicine, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14], Humans, Cumulative incidence, Survival rate, Capecitabine, Digestive System Surgical Procedures, Neoplasm Staging, Netherlands, business.industry, Rectal Neoplasms, total mesorectal excision, Incidence, Hematology, Middle Aged, medicine.disease, Prognosis, Total mesorectal excision, Chemotherapy regimen, Combined Modality Therapy, Surgery, Radiation therapy, Survival Rate, adjuvant chemotherapy, Oncology, Chemotherapy, Adjuvant, preoperative chemoradiotherapy, Female, Radiotherapy, Adjuvant, Fluorouracil, Neoplasm Recurrence, Local, business, Chemoradiotherapy, Follow-Up Studies
Abstract

The discussion on the role of adjuvant chemotherapy for rectal cancer patients treated according to current guidelines is still ongoing. A multicentre, randomized phase III trial, PROCTOR-SCRIPT, was conducted to compare adjuvant chemotherapy with observation for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision (TME).The PROCTOR-SCRIPT trial recruited patients from 52 hospitals. Patients with histologically proven stage II or III rectal adenocarcinoma were randomly assigned (1:1) to observation or adjuvant chemotherapy after preoperative (chemo)radiotherapy and TME. Radiotherapy consisted of 5 ? 5 Gy. Chemoradiotherapy consisted of 25 ? 1.8-2 Gy combined with 5-FU-based chemotherapy. Adjuvant chemotherapy consisted of 5-FU/LV (PROCTOR) or eight courses capecitabine (SCRIPT). Randomization was based on permuted blocks of six, stratified according to centre, residual tumour, time between last irradiation and surgery, and preoperative treatment. The primary end point was overall survival.Of 470 enrolled patients, 437 were eligible. The trial closed prematurely because of slow patient accrual. Patients were randomly assigned to observation (n = 221) or adjuvant chemotherapy (n = 216). After a median follow-up of 5.0 years, 5-year overall survival was 79.2% in the observation group and 80.4% in the chemotherapy group [hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.62-1.39; P = 0.73]. The HR for disease-free survival was 0.80 (95% CI 0.60-1.07; P = 0.13). Five-year cumulative incidence for locoregional recurrences was 7.8% in both groups. Five-year cumulative incidence for distant recurrences was 38.5% and 34.7%, respectively (P = 0.39).The PROCTOR-SCRIPT trial could not demonstrate a significant benefit of adjuvant chemotherapy with fluoropyrimidine monotherapy after preoperative (chemo)radiotherapy and TME on overall survival, disease-free survival, and recurrence rate. However, this trial did not complete planned accrual.Dutch Colorectal Cancer group, CKTO 2003-16, ISRCTN36266738.? The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Published
2015
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3. 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
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4. 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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