A prospective double-blind multi-centre trial: Laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis (Sigma-trial).
Suspended
- Conditions
- 1. Diverticulitis<br />2. sigmoid resection.
- Registration Number
- NL-OMON25115
- Lead Sponsor
- VU medical center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 104
Inclusion Criteria
1. Patients who were admitted for a conservatively treated episode of diverticulitis, who will therefore undergo an elective resection of the sigmoid;
2. The indication for elective resection is in patients <50 years after one episode of conservatively treated diverticulitis and in patients older than 50 years after two episodes of diverticulitis or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits;
Exclusion Criteria
1. Signs of acute diverticulitis;
2. Previous infra umbilical laparotomy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Morbidity; <br /><br>2. Mortality;<br /><br>3. Hospital stay;<br /><br>4. Conversion rate.
- Secondary Outcome Measures
Name Time Method 1. Operating time;<br /><br>2. Blood loss;<br /><br>3. Painscore;<br /><br>4. Return to normal diet;<br /><br>5. Use of analgetics;<br /><br>6. General health (SF-36).