Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Singapore General Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The primary endpoint was postoperative complication rates.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Emergency endoscopic colonic stenting (Procedure)
Emergency surgery
Emergency surgery: Patients underwent emergency surgery for acute left-sided malignant colonic obstruction.
Intervention: Emergency surgery (Procedure)
Outcomes
Primary Outcomes
The primary endpoint was postoperative complication rates.
Time Frame: 30 days
Secondary Outcomes
- 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)