aparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).
Completed
- Conditions
- Diverticulitis, Diverticular disease, Divertikelziekte, Divertikels, Hartmann, Hartmann's procedure, Primary anastomosis, Primaire anastomose, Laparoscopic lavage, Laparoscopische lavage, Hinchey III, Hinchey IV, Purulent peritonitis, Faecal peritonitis, Purulente peritonitis, Faecale peritonitis
- Registration Number
- NL-OMON27671
- Lead Sponsor
- Academic Medical Center, AmsterdamInitiator: Prof. Dr. W.A. Bemelman Erasmus Medical Center, Rotterdam, Initiator: Prof. Dr. J.F Lange
- Brief Summary
Swank HA, Vermeulen J, Lange JF, et al. The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037). BMC Surg 2010; 10: 29. (Studie protocol)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 283
Inclusion Criteria
1. Clinical suspicion for perforated diverticulitis;
2. Free abdominal gas on CT-scan or plain abdominal X-ray OR peritonitis with diffuse gas or fluid on CT-scan;
Exclusion Criteria
1. Prior Sigmoidresection;
2. Dementia;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. (LOLA-arm) 1 year combined endpoint of major morbidity and mortality for patients randomised between laparoscopic lavage or open resection; <br /><br>2. (DIVA-arm) 1 year stoma free survival for patients randomised between Hartmann's procedure or sigmoidresection with primary anastomosis.
- Secondary Outcome Measures
Name Time Method 1. Operating time;<br /><br>2. Hospital Stay;<br /><br>3. Number of days alive and outside the hospital;<br /><br>4. Incisional hernia rate;<br /><br>5. Number of reinterventions;<br /><br>6. Quality of Life;<br /><br>7. Cost-effectiveness.