aparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial
Completed
- Conditions
- perforated diverticulitis1001353510017998
- Registration Number
- NL-OMON33349
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 345
Inclusion Criteria
Patient between 18 and 85 years of age
Free abdominal air on plain abdominal X-ray or CT-scan
Informed consent
Exclusion Criteria
Dementia
Prior sigmoidectomy
Pelvic irradiation
Steroid treatment >20mg daily
Requirement of inotropics due to circulatory insufficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The following main outcomes will be assessed in this trial to compare the<br /><br>various strategies: Poor clinical outcome defined as a combined endpoint<br /><br>consisting of mortality, and major morbidity. Major morbidity includes any of<br /><br>the following events or conditions: reintervention, wound dehiscence/incisional<br /><br>hernia, abscess needing percutaneous drainage, urosepsis, myocardial<br /><br>infarction, renal failure and respiratory insufficiency. This will be the<br /><br>primary outcome in the lavage vs. resectional intervention comparison (LOLA).<br /><br>Stoma-free survival one year after initial surgery, is the only relevant and<br /><br>primary outcome for the comparison of the resectional strategies (DIVA). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are operating time, hospital stay, number of days alive and<br /><br>outside the hospital, incisional hernia, reinterventions within twelve months,<br /><br>health related quality of life, health care utilization and associated costs.</p><br>