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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28044
Enrollment
120
Registered
2006-10-20
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute left-sided malignant colonic obstruction

Interventions

Patients will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery.

Sponsors

P. Fockens, MD, PhD, professor of Endoscopy Academic Medical Center Dept. of gastroenterology, C2 PO Box 22700 1100 DE Amsterdam the Netherlands tel: 0031 (0)20 5663534 fax: 0031 (0)20 6917033 e-mail: p.fockens@amc.nl
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Effectiveness of both strategies in terms of quality of life, morbidity and mortality.

Secondary

MeasureTime frame
Costs of both strategies.

Contacts

Public ContactIlja Peute

Academic Medical Center (AMC), Department of gastroenterology, C2, P.O. Box 22760

info@stent-in.nl+31 (0)6 30023579

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)