Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis (Ladies)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
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: March 20, 2014
Last verified: March 2014
  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.


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: 283
Study Start Date: April 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Purulent peritonitis

Patients with purulent peritonitis are randomised at a 2:1:1 ratio between

  1. Laparoscopic lavage and drainage
  2. Sigmoidectomy with primary anastomosis
  3. Sigmoidectomy with end-colostomy
Procedure: Laparoscopic lavage and drainage

[CLOSED] 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.

***This part of the study was closed in 2013 on advice of the data and safety monitoring board due to safety issues

Procedure: Sigmoidectomy with primary anastomosis
[OPEN] 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.
Other Name: Sigmoid resection
Procedure: Sigmoidectomy with end-colostomy
[OPEN] 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
Experimental: Fecal peritonitis or overt perforation

Patients with fecal peritonitis or an overt perforation are randomised between

  1. Sigmoidectomy with primary anastomosis
  2. Sigmoidectomy with end-colostomy
Procedure: Sigmoidectomy with primary anastomosis
[OPEN] 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.
Other Name: Sigmoid resection
Procedure: Sigmoidectomy with end-colostomy
[OPEN] 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

Detailed Description:

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.

After closure of the LOLA-arm due to safety concerns for laparoscopic lavage, the protocol and sample size has for the DIVA-arm been adjusted to 118 patients per study arm (faecal or purulent peritonitis).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 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 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 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 20, 2014
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):
end-colostomy
diverticulitis
perforation
sigmoidectomy
sigmoid resection
lavage
laparoscopic
wash-out
rinsing
hartmann
primary anastomosis

Additional relevant MeSH terms:
Diverticulitis
Peritonitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on August 20, 2014