Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

Phase 3

• Conditions: Bowel Obstruction; Colorectal Cancer

• Registration Number: NCT00164879
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The aim of this study is to compare the stoma rate, clinical efficacy, and safety of patients treated by endoscopic stenting followed by elective laparoscopic resection (the 'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided colorectal cancers.

Detailed Description

In patients who present with obstructing left-sided colorectal cancers, emergency surgery carries a significant morbidity and mortality. Traditionally, most of these patients would receive staged operations (Hartmann's procedure). Temporary stoma is often required due to the edematous bowel wall precluding primary anastomosis as a result of obstruction and the poor pre-morbid status. A second operation is subsequently required to restore bowel continuity. Apart from the expensive hospital costs of the staged operations, the patient's acceptance to the stoma is poor and the social inconvenience associated with the stoma is obvious. Thus, a significant portion of patients would not be suitable for the second operation due to poor health or advanced disease and having to bear the stoma for the remainder of life. Recently, self-expandable metal stents have been used with success in relieving the acute obstruction in patients with obstructing left-sided colorectal cancers. Endoscopic stenting may help to relieve the obstruction, avoid emergency surgery, and allows patients to undergo one-stage elective surgery without the necessity of making a stoma. We propose to evaluate the clinical benefits of using self-expandable metal stents in patients with obstructing left-sided colorectal cancers followed by elective laparoscopic resection and compare its use to immediate emergency surgery.

Study Timeline

• Study Start: 2000-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Last Update Submitted: 2007-08-06
• Last Update Posted: 2007-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Consecutive patients with obstructing colorectal cancers, confirmed on water-soluble contrast enema or computed tomography (CT) scan
• Consented patients

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Exclusion Criteria

• Patients with peritonitis that required immediate surgical intervention
• Patients with distal rectal cancers that are not suitable for stenting
• Moribund patients, unfit for surgery otherwise
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The stoma rate in the two groups of patients
The success rate of relieving obstruction after stent insertion

Secondary Outcome Measures

Name	Time	Method
Hospital stay
Morbidity and mortality rates in the two groups

Trial Locations

Locations (1)

Endoscopy Centre, Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China