Randomized Trial of Colonic Stents as a Bridge to Surgery

Singapore Health Services (SingHealth)

Status and phase: Completed; Phase 3

Conditions: Intestinal Obstruction; Colorectal Cancer

Treatments: Procedure: Emergency surgery; Procedure: Emergency endoscopic colonic stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT00758186

Colonic-Stenting-001

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Colonic-stenting

Experimental group

Description:

Colonic-stenting and elective surgery: Emergency endoscopic colonic stenting followed by elective surgery at a later date for acute left-sided malignant colonic obstruction.

Treatment:

Procedure: Emergency endoscopic colonic stenting

Emergency surgery

Active Comparator group

Description:

Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.

Treatment:

Procedure: Emergency surgery