search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial.


- candidate number2294
- NTR NumberNTR809
- ISRCTNISRCTN46462267
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR20-okt-2006
- Secondary IDsN/A 
- Public TitleColonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial.
- Scientific TitleColonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial.
- ACRONYMStent-in 2 study
- hypothesisWhich 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) studiedColonic obstruction, Colorectal surgery
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-jan-2010
- Target number of participants120
- InterventionsPatients will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery.
- Primary outcomeEffectiveness of both strategies in terms of quality of life, morbidity and mortality.
- Secondary outcomeCosts of both strategies.
- Timepoints
- Trial web sitehttp://www.stent-in.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Ilja Peute
- CONTACT for SCIENTIFIC QUERIESDr. P. Fockens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/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)
- RECORD20-okt-2006 - 5-apr-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl