Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis
- Conditions
- Perforated Diverticulitis
- Interventions
- Procedure: Laparoscopic lavage and drainageProcedure: Sigmoidectomy with primary anastomosisProcedure: Sigmoidectomy with end-colostomy
- Registration Number
- NCT01317485
- Brief Summary
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.
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 283
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
- dementia
- prior sigmoidectomy
- steroid treatment > 20 mg daily
- prior pelvic irradiation
- preoperative shock: requirement of inotropics due to circulatory insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Purulent peritonitis Laparoscopic lavage and drainage 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 Purulent peritonitis Sigmoidectomy with primary anastomosis 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 Purulent peritonitis Sigmoidectomy with end-colostomy 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 Fecal peritonitis or overt perforation Sigmoidectomy with primary anastomosis Patients with fecal peritonitis or an overt perforation are randomised between 1. Sigmoidectomy with primary anastomosis 2. Sigmoidectomy with end-colostomy Fecal peritonitis or overt perforation Sigmoidectomy with end-colostomy Patients with fecal peritonitis or an overt perforation are randomised between 1. Sigmoidectomy with primary anastomosis 2. Sigmoidectomy with end-colostomy
- Primary Outcome Measures
Name Time Method Mortality and major morbidity (combined) One-year 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 One year Stoma-free survival one year after initial surgery, is the primary outcome for the comparison of the resectional strategies (DIVA).
- Secondary Outcome Measures
Name Time Method Operating time - (day 1) Hospital stay - (day one until discharge from hospital) Number of days alive and outside the hospital One year Incisional hernia One year Reinterventions One year All reinterventions within a one year time frame, including percutaneous abscess drainage.
Health related quality of life One year SF-36, EQ-5D, GIQLI measured at 2, 4, 13 and 26 weeks after primary surgery.
Health care utilisation and associated costs One year SF-HLQ measured at 4, 13, 26, 39 and 52 weeks after primary surgery
Trial Locations
- Locations (41)
Onze Lieve Vrouwe Hospital
🇳🇱Amsterdam, Netherlands
Alysis Medical Centre
🇳🇱Arnhem, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Medical Spectrum Twente
🇳🇱Enschede, Netherlands
Groene Hart Hospital
🇳🇱Gouda, Netherlands
Atrium Medical Centre
🇳🇱Heerlen and Brunssum, Netherlands
Tergooi Hospitals
🇳🇱Hilversum and Blaricum, Netherlands
Spaarne Hospital
🇳🇱Hoofddorp, Netherlands
Westfries Hospital
🇳🇱Hoorn, Netherlands
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
Orbis Medical Centre
🇳🇱Sittard, Netherlands
Zaans Medical Centre
🇳🇱Zaandam, Netherlands
University Hospital Leuven
🇧🇪Leuven, Belgium
Albert Schweitzer Hospital
🇳🇱Dordrecht and Zwijndrecht, Netherlands
Slotervaart Hospital
🇳🇱Amsterdam, Netherlands
Deventer Hospital
🇳🇱Deventer, Netherlands
Gelderse Vallei Hospital
🇳🇱Ede, Netherlands
University Clinic St. Luc
🇧🇪Brussels, Belgium
Flevo Hospital
🇳🇱Almere, Netherlands
Free University Medical Centre
🇳🇱Amsterdam, Netherlands
Rijnland Hospital
🇳🇱Alphen aan de Rijn and Leiderdorp, Netherlands
St. Lucas Andreas Hospital
🇳🇱Amsterdam, Netherlands
Rode Kruis Hospital
🇳🇱Beverwijk, Netherlands
Kennemer Hospital
🇳🇱Haarlem, Netherlands
Leiden University Medical Centre
🇳🇱Leiden, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
St. Franciscus Hospital
🇳🇱Rotterdam, Netherlands
University Medical Centre Utrecht
🇳🇱Utrecht, Netherlands
Erasmus Medical Centre
🇳🇱Rotterdam, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Ikazia Hospital
🇳🇱Rotterdam, Netherlands
Jeroen Bosch Hospital
🇳🇱's-Hertogenbosch, Netherlands
Meander Medical Centre
🇳🇱Amersfoort, Netherlands
Academic Medical Centre
🇳🇱Amsterdam, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Reinier de Graaf Hospital
🇳🇱Delft, Netherlands
IJsselland Hospital
🇳🇱Capelle aan de IJssel, Netherlands
Haga Hospital
🇳🇱The Hague, Netherlands
Twee Steden Hospital
🇳🇱Tilburg and Waalwijk, Netherlands
Máxima Medical Centre
🇳🇱Veldhoven, Netherlands
Isala Hospitals
🇳🇱Zwolle, Netherlands