Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis (Ladies)
This study is currently recruiting participants.
Verified April 2010 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01317485
First received: March 16, 2011
Last updated: NA
Last verified: April 2010
History: No changes posted
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Purpose
The first objective (LOLA) of this integrated trial is to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis or sigmoidectomy with end-colostomy is the superior approach in patients with perforated diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival. The study is designed as a multicenter and randomised trial. Patients diagnosed as having perforated diverticulitis with free air on plain abdominal X-ray or CT scan fulfilling the in- and exclusion criteria are randomised during laparoscopy via a central computer. In case of purulent diverticulitis patients are randomised to three arms: (a) laparoscopic lavage, (b) sigmoidectomy with colostomy or (c) sigmoidectomy with anastomosis in ratio of 2:1:1. In case of faecal peritonitis or an overt perforation of the sigmoid, the patient will be randomised 1:1 to sigmoidectomy with colostomy or sigmoidectomy with primary anastomosis. The first primary outcome parameter consists of a combined endpoint consisting of mortality and major morbidity (LOLA). The second primary endpoint consists of stoma-free survival one year after initial surgery (DIVA). Secondary endpoints are number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. A sample size of 132:66:66 patients per treatment arm will be able to detect a difference in the combined endpoint of serious complications and mortality from 25% in the two sigmoidectomy groups compared to 10% in the lavage group (two-side alpha of 5% and a power of 90%. In the DIVA analysis 2x132 patients are needed to significantly demonstrate a difference of 30% in stoma-free survival between both treatment arms (log rank test two-sided alpha of 5% and power of 90%) in favour of the patients with primary anastomosis. More than 35 hospitals will participate in this study with an estimated total inclusion of 100 patients per year. Patients will be followed for one year.
The study will be executed in concordance with the protocol, the Good Clinical Practice guidelines and regulatory requirements.
| Condition | Intervention | Phase |
|---|---|---|
|
Perforated Diverticulitis |
Procedure: Laparoscopic lavage and drainage Procedure: Sigmoidectomy with primary anastomosis Procedure: Sigmoidectomy with end-colostomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis: a Nationwide Multicenter Randomised Trial |
Resource links provided by NLM:
Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Primary Outcome Measures:
- Mortality and major morbidity (combined) [ Time Frame: One-year ] [ Designated as safety issue: Yes ]The primary outcome in the lavage vs. resectional intervention comparison (LOLA), will be poor clinical outcome, defined as a combined endpoint consisting of mortality and major morbidity one year after initial surgery. Major morbidity includes any of the following events or conditions: reintervention, wound dehiscence, incisional hernia, abscess needing percutaneous drainage, urosepsis, myocardial infarction, renal failure and respiratory insufficiency.
- Stoma-free survival [ Time Frame: One year ] [ Designated as safety issue: Yes ]Stoma-free survival one year after initial surgery, is the primary outcome for the comparison of the resectional strategies (DIVA).
Secondary Outcome Measures:
- Operating time [ Time Frame: - (day 1) ] [ Designated as safety issue: No ]
- Hospital stay [ Time Frame: - (day one until discharge from hospital) ] [ Designated as safety issue: No ]
- Number of days alive and outside the hospital [ Time Frame: One year ] [ Designated as safety issue: No ]
- Incisional hernia [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Reinterventions [ Time Frame: One year ] [ Designated as safety issue: Yes ]All reinterventions within a one year time frame, including percutaneous abscess drainage.
- Health related quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]SF-36, EQ-5D, GIQLI measured at 2, 4, 13 and 26 weeks after primary surgery.
- Health care utilisation and associated costs [ Time Frame: One year ] [ Designated as safety issue: No ]SF-HLQ measured at 4, 13, 26, 39 and 52 weeks after primary surgery
| Estimated Enrollment: | 396 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PURULENT: laparoscopic lavage and drainage
Purulent peritonitis: laparoscopic lavage and drainage
|
Procedure: Laparoscopic lavage and drainage
The abdominal cavity is irrigated with six litres of warm saline in all four quadrants. At the end of the procedure a Douglas drain is inserted via the right lateral port.
|
|
Active Comparator: PURULENT: sigmoidectomy with primary anastomosis
Purulent peritonitis: sigmoidectomy with primary anastomosis, with or without protective loop-ileostomy
|
Procedure: Sigmoidectomy with primary anastomosis
Sigmoidectomy is done according to the guidelines of the American Society of Colon and Rectal Surgeons. The distal transsection margin has to be on the proximal rectum, the proximal margin is determined by the absence of wall thickening due to diverticulitis. The type of anastomosis is done according to the preference of the operating surgeon. A loop ileostomy can be fashioned in order to ensure faecal deviation to the discretion of the surgeon.
|
|
Active Comparator: PURULENT: sigmoidectomy with end-colostomy
Purulent peritonitis: sigmoidectomy with end-colostomy
|
Procedure: Sigmoidectomy with end-colostomy
This is a two-stage procedure with the intention to close the colostomy in a second stage. During the primary surgery, only the perforated diseased part must be resected. There is no need of having the distal transsection line on the proximal rectum.
Other Name: Hartmann procedure
|
|
Active Comparator: FAECAL: sigmoidectomy with primary anastomosis
Faecal peritonitis or overt perforation: sigmoidectomy with primary anastomosis, with or without protective loop-ileostomy
|
Procedure: Sigmoidectomy with primary anastomosis
Sigmoidectomy is done according to the guidelines of the American Society of Colon and Rectal Surgeons. The distal transsection margin has to be on the proximal rectum, the proximal margin is determined by the absence of wall thickening due to diverticulitis. The type of anastomosis is done according to the preference of the operating surgeon. A loop ileostomy can be fashioned in order to ensure faecal deviation to the discretion of the surgeon.
|
|
Active Comparator: FAECAL: sigmoidectomy with end-colostomy
Faecal peritonitis or overt perforation: sigmoidectomy with end-colostomy
|
Procedure: Sigmoidectomy with end-colostomy
This is a two-stage procedure with the intention to close the colostomy in a second stage. During the primary surgery, only the perforated diseased part must be resected. There is no need of having the distal transsection line on the proximal rectum.
Other Name: Hartmann procedure
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
patients suspected of diverticulitis
- age in between 18 and 85 years old
- with written informed consent
- with free air on plain abdominal or thoracic X-ray or CT-scan OR with peritonitis and diffuse gas or fluid on CT-scan
Exclusion Criteria:
- dementia
- prior sigmoidectomy
- steroid treatment > 20 mg daily
- prior pelvic irradiation
- preoperative shock: requirement of inotropics due to circulatory insufficiency
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317485
Contacts
| Contact: W.A. Bemelman, Professor | w.a.bemelman@amc.uva.nl | |
| Contact: J.F. Lange, Professor | j.f.lange@erasmusmc.nl |
Locations
| Belgium | |
| University Clinic St. Luc | Not yet recruiting |
| Brussels, Belgium | |
| Contact: A. Kartheuser | |
| Sub-Investigator: C. Remue | |
| University Hospital Leuven | Not yet recruiting |
| Leuven, Belgium | |
| Contact: A. d'Hoore | |
| Netherlands | |
| Jeroen Bosch Hospital | Recruiting |
| 's-Hertogenbosch, Netherlands | |
| Contact: H. Prins | |
| Flevo Hospital | Recruiting |
| Almere, Netherlands | |
| Contact: M. Boom | |
| Rijnland Hospital | Not yet recruiting |
| Alphen aan de Rijn and Leiderdorp, Netherlands | |
| Contact: P.A. Neijenhuis | |
| Meander Medical Centre | Recruiting |
| Amersfoort, Netherlands | |
| Contact: E.C.J. Consten | |
| Academic Medical Centre | Recruiting |
| Amsterdam, Netherlands | |
| Contact: W.A. Bemelman | |
| Free University Medical Centre | Recruiting |
| Amsterdam, Netherlands | |
| Contact: D.L. van der Peet | |
| Slotervaart Hospital | Recruiting |
| Amsterdam, Netherlands | |
| Contact: S.C. Bruin | |
| Onze Lieve Vrouwe Hospital | Recruiting |
| Amsterdam, Netherlands | |
| Contact: M.F. Gerhards | |
| St. Lucas Andreas Hospital | Recruiting |
| Amsterdam, Netherlands | |
| Contact: B.A. van Wagensveld | |
| Alysis Medical Centre | Recruiting |
| Arnhem, Netherlands | |
| Contact: C.F.J.M. Blanken-Peeters | |
| Rode Kruis Hospital | Recruiting |
| Beverwijk, Netherlands | |
| Contact: H.A. Cense | |
| Amphia Hospital | Recruiting |
| Breda, Netherlands | |
| Contact: R.M.P.M. Crolla | |
| IJsselland Hospital | Recruiting |
| Capelle aan de IJssel, Netherlands | |
| Contact: E.J.R. de Graaf | |
| Reinier de Graaf Hospital | Recruiting |
| Delft, Netherlands | |
| Contact: T.M. Karsten | |
| Deventer Hospital | Not yet recruiting |
| Deventer, Netherlands | |
| Contact: R.J.I. Bosker | |
| Albert Schweitzer Hospital | Recruiting |
| Dordrecht and Zwijndrecht, Netherlands | |
| Contact: J.A.B. van der Hoeven | |
| Gelderse Vallei Hospital | Recruiting |
| Ede, Netherlands | |
| Contact: Ph.M. Kruyt | |
| Catharina Hospital | Recruiting |
| Eindhoven, Netherlands | |
| Contact: S.W. Nienhuijs | |
| Medical Spectrum Twente | Recruiting |
| Enschede, Netherlands | |
| Contact: E.B. van Duyn | |
| Groene Hart Hospital | Recruiting |
| Gouda, Netherlands | |
| Contact: D.J. Swank | |
| Kennemer Hospital | Recruiting |
| Haarlem, Netherlands | |
| Contact: H.B.A.C. Stockmann | |
| Atrium Medical Centre | Not yet recruiting |
| Heerlen and Brunssum, Netherlands | |
| Contact: M.N. Sosef | |
| Tergooi Hospitals | Recruiting |
| Hilversum and Blaricum, Netherlands | |
| Contact: A.A.W. van Geloven | |
| Spaarne Hospital | Recruiting |
| Hoofddorp, Netherlands | |
| Contact: Q.A.J. Eijsbouts | |
| Westfries Hospital | Recruiting |
| Hoorn, Netherlands | |
| Contact: M.J.P.M. Govaert | |
| Leiden University Medical Centre | Not yet recruiting |
| Leiden, Netherlands | |
| Contact: R.A.E.M. Tollenaar | |
| Maastricht University Medical Centre | Not yet recruiting |
| Maastricht, Netherlands | |
| Contact: L.P.S. Stassen | |
| St. Antonius Hospital | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: M.J. Wiezer | |
| Erasmus Medical Centre | Recruiting |
| Rotterdam, Netherlands | |
| Contact: J.F. Lange | |
| St. Franciscus Hospital | Recruiting |
| Rotterdam, Netherlands | |
| Contact: G.H.H. Mannaerts | |
| Maasstad Hospital | Recruiting |
| Rotterdam, Netherlands | |
| Contact: P.P.L.O. Coene | |
| Ikazia Hospital | Not yet recruiting |
| Rotterdam, Netherlands | |
| Contact: W.F. Weidema | |
| Orbis Medical Centre | Recruiting |
| Sittard, Netherlands | |
| Contact: A.G.M. Hoofwijk | |
| Haga Hospital | Recruiting |
| The Hague, Netherlands | |
| Contact: W.H. Steup | |
| Twee Steden Hospital | Recruiting |
| Tilburg and Waalwijk, Netherlands | |
| Contact: J.K. Maring | |
| University Medical Centre Utrecht | Recruiting |
| Utrecht, Netherlands | |
| Contact: W.M.U. van Grevenstein | |
| Máxima Medical Centre | Recruiting |
| Veldhoven, Netherlands | |
| Contact: G.D. Slooter | |
| Zaans Medical Centre | Recruiting |
| Zaandam, Netherlands | |
| Contact: A.F. Engel | |
| Isala Hospitals | Recruiting |
| Zwolle, Netherlands | |
| Contact: E.G.J.M. Pierik | |
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | J.F. Lange, Professor | Erasmus Medical Centre, Rotterdam |
| Principal Investigator: | W.A. Bemelman, Professor | Academic Medical Centre, Amsterdam |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof. dr. W.A. Bemelman / Prof. dr. J.F. Lange, Academic Medical Centre Amsterdam / Erasmus Medical Centre Rotterdam |
| ClinicalTrials.gov Identifier: | NCT01317485 History of Changes |
| Other Study ID Numbers: | NTR2037 |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 16, 2011 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: ZonMw, Netherlands Organisation for Health Research and Development Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
diverticulitis perforation sigmoidectomy sigmoid resection lavage laparoscopic |
wash-out rinsing hartmann end-colostomy primary anastomosis |
Additional relevant MeSH terms:
|
Diverticulitis Peritonitis Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Peritoneal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013