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1. European Society of Coloproctology: guidelines for the management of diverticular disease of the colon

Author

Schultz, J.K. (J. K.), Azhar, N. (N.), Binda, G.A. (G. A.), Barbara, G. (G.), Biondo, S. (S.), Boermester, M.A. (M. A.), Chabok, A. (A.), Consten, E.C. (Esther), Dijk, S.M. (Sven) van, Johanssen, A. (A.), Kruis, W. (W.), Lambrichts, D.P.V. (Daniël), Post, S. (S.), Ris, F. (F.), Rockall, T.A. (T. A.), Samuelsson, A. (A.), Di Saverio, S. (Salomone), Tartaglia, D. (D.), Thorisson, A. (A.), Winter, D.C. (D. C.), Bemelman, W.A., Angenete, E. (E.), Schultz, J.K. (J. K.), Azhar, N. (N.), Binda, G.A. (G. A.), Barbara, G. (G.), Biondo, S. (S.), Boermester, M.A. (M. A.), Chabok, A. (A.), Consten, E.C. (Esther), Dijk, S.M. (Sven) van, Johanssen, A. (A.), Kruis, W. (W.), Lambrichts, D.P.V. (Daniël), Post, S. (S.), Ris, F. (F.), Rockall, T.A. (T. A.), Samuelsson, A. (A.), Di Saverio, S. (Salomone), Tartaglia, D. (D.), Thorisson, A. (A.), Winter, D.C. (D. C.), Bemelman, W.A., and Angenete, E. (E.)

Abstract

Aim: The goal of this European Society of Coloproctology (ESCP) guideline project is to give an overview of the existing evidence on the management of diverticular disease, primarily as a guidance to surgeons. Methods: The guideline was developed during several working phases including three voting rounds and one consensus meeting. The two project leads (JKS and EA) appointed by the ESCP guideline committee together with one member of the guideline committee (WB) agreed on the methodology, decided on six themes for working groups (WGs) and drafted a list of research questions. Senior WG members, mostly colorectal surgeons within the ESCP, were invited based on publication records and geographical aspects. Other specialties were included in the WGs where relevant. In addition, one trainee or PhD fellow was invited in each WG. All six WGs revised the research questions if necessary, did a literature search, created evidence tables where feasible, and drafted supporting text to each research question and statement. The text and statement proposals from each WG were arranged as one document by the first and last authors before online voting by all authors in two rounds. For the second voting ESCP national representatives were also invited. More than 90% agreement was considered a consensus. The final phrasing of the statements with < 90% agreement was discussed in a consensus meeting at the ESCP annual meeting in Vienna in September 2019. Thereafter, the first and the last author drafted the final text of the guideline and circulated it for final approval and for a third and final online voting of rephrased statements. Results: This guideline contains 38 evidence based consensus statements on the management of diverticular disease. Conclusion: This international, multidisciplinary guideline provides an up to date summary of the current knowledge of the management of diverticular disease as a guidance for clinicians and patients.

Published
2020
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2. Volume–outcome relationship of liver surgery: a nationwide analysis

Author

Olthof, P.B. (P. B.), Elfrink, A.K.E. (A. K.E.), Marra, E. (E.), Belt, E.J.T. (Eric), Boezem, P.B. van den, Bosscha, K. (Koop), Consten, E.C. (Esther), den Dulk, M. (M.), Gobardhan, P.D. (Paul), Hagendoorn, J. (Jeroen), van Heek, T.N.T. (T. N.T.), IJzermans, J.N.M. (Jan), Klaase, J.M. (Joost), Kuhlmann, K.F.D. (K. F.D.), Leclercq, W.K.G. (W. K.G.), Liem, M. (Marieke), Manusama, E.R. (Eric), Marsman, H.A. (H. A.), Mieog, J.S.D. (Sven), Oosterling, S.J. (S.), Patijn, G.A. (Gijs A.), te Riele, W. (W.), Swijnenburg, R.-J. (R. J.), Torrenga, H. (H.), Duijvendijk, P. (Peter) van, Vermaas, M. (Maarten), Kok, N.F.M. (Niels), Grunhagen, D.J. (Dirk Jan), Besselink, M.G. (Marc), Boer, M.T. (Marieke) de, Buis, C.I. (Carlijn I.), Gulik, T.M. (Thomas) van, Hoogwater, F.J.H. (F. J.H.), Molenaar, I.Q. (I. Quintus), Dejong, C.H. (Cees), Verhoef, C. (Kees), Olthof, P.B. (P. B.), Elfrink, A.K.E. (A. K.E.), Marra, E. (E.), Belt, E.J.T. (Eric), Boezem, P.B. van den, Bosscha, K. (Koop), Consten, E.C. (Esther), den Dulk, M. (M.), Gobardhan, P.D. (Paul), Hagendoorn, J. (Jeroen), van Heek, T.N.T. (T. N.T.), IJzermans, J.N.M. (Jan), Klaase, J.M. (Joost), Kuhlmann, K.F.D. (K. F.D.), Leclercq, W.K.G. (W. K.G.), Liem, M. (Marieke), Manusama, E.R. (Eric), Marsman, H.A. (H. A.), Mieog, J.S.D. (Sven), Oosterling, S.J. (S.), Patijn, G.A. (Gijs A.), te Riele, W. (W.), Swijnenburg, R.-J. (R. J.), Torrenga, H. (H.), Duijvendijk, P. (Peter) van, Vermaas, M. (Maarten), Kok, N.F.M. (Niels), Grunhagen, D.J. (Dirk Jan), Besselink, M.G. (Marc), Boer, M.T. (Marieke) de, Buis, C.I. (Carlijn I.), Gulik, T.M. (Thomas) van, Hoogwater, F.J.H. (F. J.H.), Molenaar, I.Q. (I. Quintus), Dejong, C.H. (Cees), and Verhoef, C. (Kees)

Abstract

Background: Evidence for an association between hospital volume and outcomes for liver surgery is abundant. The current Dutch guideline requires a minimum volume of 20 annual procedures per centre. The aim of this study was to investigate the association between hospital volume and postoperative outcomes using data from the nationwide Dutch Hepato Biliary Audit. Methods: This was a nationwide study in the Netherlands. All liver resections reported in the Dutch Hepato Biliary Audit between 2014 and 2017 were included. Annual centre volume was calculated and classified in categories of 20 procedures per year. Main outcomes were major morbidity (Clavien–Dindo grade IIIA or higher) and 30-day or in-hospital mortality. Results: A total of 5590 liver resections were done across 34 centres with a median annual centre volume of 35 (i.q.r. 20–69) procedures. Overall major morbidity and mortality rates were 11·2 and 2·0 per cent respectively. The mortality rate was 1·9 per cent after resection for colorectal liver metastases (CRLMs), 1·2 per cent for non-CRLMs, 0·4 per cent for benign tumours, 4·9 per cent for hepatocellular carcinoma and 10·3 per cent for biliary tumours. Higher-volume centres performed more major liver resections, and more resections for hepatocellular carcinoma and biliary cancer. There was no association between hospital volume and either major morbidity or mortality in multivariable analysis, after adjustment for known risk factors for adverse events. Conclusion: Hospital volume and postoperative outcomes were not associated.

Published
2020
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3. Multicentre study of non-surgical management of diverticulitis with abscess formation

Author

Lambrichts, D.P.V. (Daniël), Bolkenstein, H.E., van der Does, D., Dieleman, D., Crolla, R.M.P.H. (Rogier), Dekker, J.W.T. (Jan Willem), Duijvendijk, P. (Peter) van, Gerhards, M.F. (Michael), Nienhuijs, S.W. (Simon), Menon, A.G. (Anand), Graaf, E.J.R. (Eelco) de, Consten, E.C. (Esther), Draaisma, W.A. (Werner), Broeders, I.A.M.J. (Ivo), Bemelman, W.A. (Willem), Lange, J.F. (Johan), Lambrichts, D.P.V. (Daniël), Bolkenstein, H.E., van der Does, D., Dieleman, D., Crolla, R.M.P.H. (Rogier), Dekker, J.W.T. (Jan Willem), Duijvendijk, P. (Peter) van, Gerhards, M.F. (Michael), Nienhuijs, S.W. (Simon), Menon, A.G. (Anand), Graaf, E.J.R. (Eelco) de, Consten, E.C. (Esther), Draaisma, W.A. (Werner), Broeders, I.A.M.J. (Ivo), Bemelman, W.A. (Willem), and Lange, J.F. (Johan)

Abstract

Background: Treatment strategies for diverticulitis with abscess formation have shifted from (emergency) surgical treatment to non-surgical management (antibiotics with or without percutaneous drainage (PCD)). The aim was to assess outcomes of non-surgical treatment and to identify risk factors for adverse outcomes. Methods: Patients with a first episode of CT-diagnosed diverticular abscess (modified Hinchey Ib or II) between January 2008 and January 2015 were included retrospectively, if initially treated non-surgically. Baseline characteristics, short-term (within 30 days) and long-term treatment outcomes were recorded. Treatment failure was a composite outcome of complications (perforation, colonic obstruction and fistula formation), readmissions, persistent diverticulitis, emergency surgery, death, or need for PCD in the no-PCD group. Regression analyses were used to analyse risk factors for treatment failure, recurrences and surgery. Results: Overall, 447 patients from ten hospitals were included (Hinchey Ib 215; Hinchey II 232), with a median follow-up of 72 (i.q.r. 55–93) months. Most patients were treated without PCD (332 of 447, 74⋅3 per cent). Univariable analyses, stratified by Hinchey grade, showed no differences between no PCD and PCD in short-term treatment failure (Hinchey I: 22⋅3 versus 33 per cent, P = 0⋅359; Hinchey II: 25⋅9 versus 36 per cent, P = 0⋅149) or emergency surgery (Hinchey I: 5⋅1 versus 6 per c

Published
2019
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4. Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial)

Author

Brunschot, S. (Sandra) van, Grinsven, J. (Janneke) van, Voermans, R.P. (Rogier), Bakker, O.J. (Olaf ), Besselink, M.G. (Marc), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bosscha, K. (Koop), Bouwense, S.A.W. (Stefan), Bruno, M.J. (Marco), Cappendijk, V.C., Consten, E.C. (Esther), Dejong, C.H. (Cees), Dijkgraaf, M.G.W. (Marcel), Eijck, C.H.J. (Casper) van, Erkelens, D.W. (Dirk Willem), Goor, H. (Harry) van, Hadithi, M. (Muhammed), Haveman, J.-W. (Jan-Willem), Hofker, S.H. (Sijbrand), Jansen, J.J.M. (Jeroen), Laméris, J.S. (Johan ), Lienden, K.P. (Krijn) van, Manusama, E.R. (Eric), Meijssen, M.A.C. (Maarten), Mulder, C.J.J. (Chris), Nieuwenhuis, V.B. (Vincent), Poley, J.-W. (Jan-Werner), Ridder, R. (Rogier) de, Rosman, C. (Camiel), Schaapherder, A.F.M. (Alexander), Scheepers, J.J. (Joris), Schoon, E.J. (Erik), Seerden, T.C.J. (Tom), Spanier, B.W.M. (Marcel), Straathof, J.W.A., Timmer, R. (Robin), Venneman, N.G. (Niels), Vleggaar, F.P. (Frank), Witteman, B.J.M. (Ben), Gooszen, H.G. (Hein), Santvoort, H.C. (Hjalmar) van, Fockens, P. (Paul), Brunschot, S. (Sandra) van, Grinsven, J. (Janneke) van, Voermans, R.P. (Rogier), Bakker, O.J. (Olaf ), Besselink, M.G. (Marc), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bosscha, K. (Koop), Bouwense, S.A.W. (Stefan), Bruno, M.J. (Marco), Cappendijk, V.C., Consten, E.C. (Esther), Dejong, C.H. (Cees), Dijkgraaf, M.G.W. (Marcel), Eijck, C.H.J. (Casper) van, Erkelens, D.W. (Dirk Willem), Goor, H. (Harry) van, Hadithi, M. (Muhammed), Haveman, J.-W. (Jan-Willem), Hofker, S.H. (Sijbrand), Jansen, J.J.M. (Jeroen), Laméris, J.S. (Johan ), Lienden, K.P. (Krijn) van, Manusama, E.R. (Eric), Meijssen, M.A.C. (Maarten), Mulder, C.J.J. (Chris), Nieuwenhuis, V.B. (Vincent), Poley, J.-W. (Jan-Werner), Ridder, R. (Rogier) de, Rosman, C. (Camiel), Schaapherder, A.F.M. (Alexander), Scheepers, J.J. (Joris), Schoon, E.J. (Erik), Seerden, T.C.J. (Tom), Spanier, B.W.M. (Marcel), Straathof, J.W.A., Timmer, R. (Robin), Venneman, N.G. (Niels), Vleggaar, F.P. (Frank), Witteman, B.J.M. (Ben), Gooszen, H.G. (Hein), Santvoort, H.C. (Hjalmar) van, and Fockens, P. (Paul)

Abstract

_Background:_ Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes. _Methods/Design:_ The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs. _Discussion:_ The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.

Published
2013
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5. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

Author

Bouwense, S.A.W. (Stefan), Besselink, M.G. (Marc), Brunschot, S. (Sandra) van, Bakker, O.J. (Olaf ), Santvoort, H.C. (Hjalmar) van, Schepers, N.J. (Nicolien), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bosscha, K. (Koop), Brink, M.A. (Menno), Bruno, M.J. (Marco), Consten, E.C. (Esther), Dejong, C.H. (Cees), Duijvendijk, P. (Peter) van, Eijck, C.H.J. (Casper) van, Gerritsen, J.J. (Jos), Goor, H. (Harry) van, Heisterkamp, J. (Joos), Hingh, I.H.J.T. (Ignace) de, Kruyt, Ph.M. (Philip), Molenaar, I.Q. (I. Quintus), Nieuwenhuijs, V.B. (Vincent), Rosman, C. (Camiel), Schaapherder, A.F.M. (Alexander), Scheepers, J.J. (Joris), Spanier, B.W.M. (Marcel), Timmer, R. (Robin), Weusten, B.L. (Bas), Witteman, B.J.M. (Ben), Ramshorst, B. (Bert) van, Gooszen, H.G. (Hein), Boerma, D. (Djamila), Bouwense, S.A.W. (Stefan), Besselink, M.G. (Marc), Brunschot, S. (Sandra) van, Bakker, O.J. (Olaf ), Santvoort, H.C. (Hjalmar) van, Schepers, N.J. (Nicolien), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Bosscha, K. (Koop), Brink, M.A. (Menno), Bruno, M.J. (Marco), Consten, E.C. (Esther), Dejong, C.H. (Cees), Duijvendijk, P. (Peter) van, Eijck, C.H.J. (Casper) van, Gerritsen, J.J. (Jos), Goor, H. (Harry) van, Heisterkamp, J. (Joos), Hingh, I.H.J.T. (Ignace) de, Kruyt, Ph.M. (Philip), Molenaar, I.Q. (I. Quintus), Nieuwenhuijs, V.B. (Vincent), Rosman, C. (Camiel), Schaapherder, A.F.M. (Alexander), Scheepers, J.J. (Joris), Spanier, B.W.M. (Marcel), Timmer, R. (Robin), Weusten, B.L. (Bas), Witteman, B.J.M. (Ben), Ramshorst, B. (Bert) van, Gooszen, H.G. (Hein), and Boerma, D. (Djamila)

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 (wit

Published
2012
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6. 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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7. 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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8. 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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9. 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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10. Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study)

Author

Broek, F.J.C. (Frank) van den, Graaf, E.J.R. (Eelco) de, Dijkgraaf, M.G.W. (Marcel), Reitsma, J.B. (Johannes), Haringsma, J. (Jelle), Timmer, R. (Robin), Weusten, B.L. (Bas), Gerhards, M.F. (Michael), Consten, E.C. (Esther), Schwartz, M.P. (Matthijs), Boom, M.J. (Maarten), Derksen, E.J. (Erik), Bijnen, A.B. (Bart), Davids, P.H.P. (Paul), Hoff, C. (Christiaan), Dullemen, H.M. (Hendrik) van, Heine, G.D.N. (Dimitri), Linde, K. (Klaas) van der, Jansen, J.M. (Jeroen Michiel), Mallant-Hent, R.C.H. (Rosalie), Breumelhof, R. (Ronald), Geldof, H. (Han), Hardwick, J.C. (James), Doornebosch, P. (Pascal), Depla, A.C.T.M. (Annekatrien), Ernst, M.F. (Miranda), Munster, I.P. (Ivo) van, Hingh, I.H.J.T. (Ignace) de, Schoon, E.J. (Erik), Bemelman, W.A. (Willem), Fockens, P. (Paul), Dekker, E. (Evelien), Broek, F.J.C. (Frank) van den, Graaf, E.J.R. (Eelco) de, Dijkgraaf, M.G.W. (Marcel), Reitsma, J.B. (Johannes), Haringsma, J. (Jelle), Timmer, R. (Robin), Weusten, B.L. (Bas), Gerhards, M.F. (Michael), Consten, E.C. (Esther), Schwartz, M.P. (Matthijs), Boom, M.J. (Maarten), Derksen, E.J. (Erik), Bijnen, A.B. (Bart), Davids, P.H.P. (Paul), Hoff, C. (Christiaan), Dullemen, H.M. (Hendrik) van, Heine, G.D.N. (Dimitri), Linde, K. (Klaas) van der, Jansen, J.M. (Jeroen Michiel), Mallant-Hent, R.C.H. (Rosalie), Breumelhof, R. (Ronald), Geldof, H. (Han), Hardwick, J.C. (James), Doornebosch, P. (Pascal), Depla, A.C.T.M. (Annekatrien), Ernst, M.F. (Miranda), Munster, I.P. (Ivo) van, Hingh, I.H.J.T. (Ignace) de, Schoon, E.J. (Erik), Bemelman, W.A. (Willem), Fockens, P. (Paul), and Dekker, E. (Evelien)

Abstract

Background: Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications. The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas. Methods/design. Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma 3 cm, located between 115 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in

Published
2009
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11. 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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12. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial)

Author

Besselink, M.G. (Marc), Santvoort, H.C. (Hjalmar) van, Nieuwenhuijs, V.B. (Vincent), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Buskens, E. (Erik), Dejong, C.H. (Cees), Eijck, C.H.J. (Casper) van, Goor, H. (Harry) van, Hofker, S. (Sijbrand), Laméris, J.S. (Johan ), Leeuwen, M.S. (Maarten), Ploeg, R.J. (Rutger), Ramshorst, B. (Bert) van, Schaapherder, A.F.M. (Alexander), Cuesta, M.A. (Miguel), Consten, E.C. (Esther), Gouma, D.J. (Dirk), Harst, E. (Erwin) van der, Hesselink, E.J. (Eric), Houdijk, L.P.J. (Lex P.), Karsten, T.M. (Thomas), Laarhoven, C.J. (Cees) van, Pierie, J.-P.E.N. (Jean-Pierre), Rosman, C. (Camiel), Bilgen, E.J.S., Timmer, R. (Robin), Tweel, I. (Ingeborg) van der, Wit, R.J. (Ralph ) de, Witteman, B.J.M. (Ben), Gooszen, H.G. (Hein), Besselink, M.G. (Marc), Santvoort, H.C. (Hjalmar) van, Nieuwenhuijs, V.B. (Vincent), Boermeester, M.A. (Marja), Bollen, T.L. (Thomas), Buskens, E. (Erik), Dejong, C.H. (Cees), Eijck, C.H.J. (Casper) van, Goor, H. (Harry) van, Hofker, S. (Sijbrand), Laméris, J.S. (Johan ), Leeuwen, M.S. (Maarten), Ploeg, R.J. (Rutger), Ramshorst, B. (Bert) van, Schaapherder, A.F.M. (Alexander), Cuesta, M.A. (Miguel), Consten, E.C. (Esther), Gouma, D.J. (Dirk), Harst, E. (Erwin) van der, Hesselink, E.J. (Eric), Houdijk, L.P.J. (Lex P.), Karsten, T.M. (Thomas), Laarhoven, C.J. (Cees) van, Pierie, J.-P.E.N. (Jean-Pierre), Rosman, C. (Camiel), Bilgen, E.J.S., Timmer, R. (Robin), Tweel, I. (Ingeborg) van der, Wit, R.J. (Ralph ) de, Witteman, B.J.M. (Ben), and Gooszen, H.G. (Hein)

Abstract

Background: The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. Methods/design: 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. Discussion: The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.

Published
2006
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