Randomized Trial of Colonic Stents as a Bridge to Surgery

Phase 3

Completed

• Conditions: Colorectal Cancer; Intestinal Obstruction
• Interventions: Procedure: Emergency endoscopic colonic stenting; Procedure: Emergency surgery

• Registration Number: NCT00758186
• Lead Sponsor: Singapore General Hospital

Brief Summary

The objective of this randomized controlled trial was to evaluate the role colonic self-expanding metal stent (SEMS) placement as a bridge to surgery in patients with acute malignant left-sided colonic obstruction. The study was designed to test the hypothesis that SEMS placement could be effectively and safely used in this group of patients to relieve colonic obstruction thereby allowing safe recovery and medical stabilization before proceeding to elective surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2008-02
• Study Completion: 2008-06
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Acute intestinal obstruction secondary to left-sided colonic cancer

Exclusion Criteria

• Distal rectal cancers
• Patients with signs of peritonitis suggestive of bowel perforation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonic-stenting	Emergency endoscopic colonic stenting	Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction.
Emergency surgery	Emergency surgery	Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.

Primary Outcome Measures

Name	Time	Method
The primary endpoint was postoperative complication rates.	30 days

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes evaluated included type of surgery performed, bowel preservation, presence of a stoma, postoperative bowel function, length of hospital stay, and hospitalization costs.	3 months

Trial Locations

Locations (1)

Department of Colorectal Surgery, Singapore General Hospital; 🇸🇬 Singapore, Singapore