Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial.
Completed
- Conditions
- acute left-sided malignant colonic obstruction
- Registration Number
- NL-OMON28044
- Lead Sponsor
- P. Fockens, MD, PhD, professor of EndoscopyAcademic Medical CenterDept. of gastroenterology, C2PO Box 227001100 DE Amsterdamthe Netherlandstel: 0031 (0)20 5663534fax: 0031 (0)20 6917033e-mail: p.fockens@amc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Symptoms of left-sided (colon descendens, sigmoid or rectum) malignant colonic obstruction existing less than one week defined as obstructive symptoms with dilation of the colon on either plain abdominal X-ray and typical abnormalities on a gastrografin enema study or CT-abdomen with contrast, compatible with a malignant colonic stricture;
2. Age > 18 years;
3. Informed consent.
Exclusion Criteria
1. Peritonitis, perforation, fever, sepsis or other serious complications demanding urgent surgery;
2. ASA IV or V;
3. Obstruction due to non-colonic malignancies or from a benign origin;
4. Distal tumor margin less than 10 cm from the anal verge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of both strategies in terms of quality of life, morbidity and mortality.
- Secondary Outcome Measures
Name Time Method Costs of both strategies.