Randomized Trial of Colonic Stents as a Bridge to Surgery

Endoscopic Stenting and Elective Surgery Versus Emergency Surgery for Left-sided Malignant Colonic Obstruction: A Prospective Randomized Trial.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00758186

Enrollment

Registered

2008-09-25

Start date

2004-10-31

Completion date

2008-06-30

Last updated

2018-04-18

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

Conditions

Colorectal Cancer, Intestinal Obstruction

Keywords

Colorectal cancer, Endoscopic stent, Intestinal obstruction, Laparoscopy

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

Interventions

PROCEDUREEmergency 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. Patients who had successful stenting were discharged and re-admitted for elective surgery. Patients in whom stenting was unsuccessful underwent emergency surgery. The choice of surgery performed was up to the individual consultant colorectal surgeon.

PROCEDUREEmergency surgery

Patients underwent emergency surgery for acute left-sided malignant colonic obstruction. The choice of surgery performed was up to the individual consultant colorectal surgeon. Surgery included primary resection with or without defunctioning stoma and palliative diverting stoma only.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint was postoperative complication rates.	30 days

Secondary

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026