|- candidate number||2294|
|- NTR Number||NTR809|
|- 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|
|- 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.|
|- 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|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- 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|