Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in II study)
Phase 3
- Conditions
- malignant left-sided colonic obstructionmalignant obstruction of the left colon100180081001799110017998
- Registration Number
- NL-OMON29875
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Symptoms of left-sided malignant colonic obstruction existing less than one week defined as obstructive symptoms with dilation of the colon on plain abdominal X-ray and typical abnormalities on a gastrografin enema study compatible with a malignant colonic stricture
Exclusion Criteria
*Peritonitis, perforation, fever, sepsis or other serious complications
demanding urgent surgery
*ASA IV or V
*Obstruction due to non-colonic malignancies or from a benign origin
*Distal tumor margin less than 10 cm from the anal verge
*Incapable of completing self-report quality of life questionnaires
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>We will compare the effectiveness of both strategies. Effectiveness will be<br /><br>evaluated in terms of quality of life, morbidity and mortality. Quality of life<br /><br>will be measured with the following standardized questionnaires: EORTC QLQ-C30,<br /><br>the colorectal cancer specific EORTC QLQ-CR38 and the EuroQol. Morbidity is<br /><br>defined as every event leading to hospital admission or prolonging hospital<br /><br>stay. Mortality will be analyzed as total mortality as well as<br /><br>procedure-related mortality. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As secundary outcome parameters we will compare costs of both strategies.</p><br>