| - candidate number | 2294 |
| - NTR Number | NTR809 |
| - ISRCTN | ISRCTN46462267 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 20-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial. |
| - Scientific Title | Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial. |
| - ACRONYM | Stent-in 2 study |
| - hypothesis | Which treatment strategy is the most effective for patients with acute left-sided malignant colonic obstruction: either colonic stenting followed by elective surgery or emergency surgery. |
| - Healt Condition(s) or Problem(s) studied | Colonic obstruction, Colorectal surgery |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-jan-2007 |
| - planned closingdate | 1-jan-2010 |
| - Target number of participants | 120 |
| - Interventions | Patients will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. |
| - Primary outcome | Effectiveness of both strategies in terms of quality of life, morbidity and mortality. |
| - Secondary outcome | Costs of both strategies. |
| - Timepoints | |
| - Trial web site | http://www.stent-in.nl |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Ilja Peute |
| - CONTACT for SCIENTIFIC QUERIES | Dr. P. Fockens |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Gastroenterology |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC) |
| - Publications | N/A |
| - Brief summary | Objective: To compare colonic stenting followed by surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in terms of health-related quality of life, morbidity and mortality. Study design: Prospective randomized multicenter trial. Study population: Patients with acute left-sided malignant colonic obstruction. Intervention: Patients will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements: Effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38 and EuroQol). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. Power/data analysis: Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Economic evaluation: The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Time schedule: Patient inclusion from January 2007 until the 31st of December 2009. Interim analysis will be done after inclusion of 60 patients. Final analysis and reporting April/October 2010. |
| - Main changes (audit trail) | |
| - RECORD | 20-okt-2006 - 5-apr-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl