Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

Colorectal Cancer Clinical Trial

Official title:

Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00164879
• Other study ID #: CRE-2002.445-T
• Status: Recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: August 6, 2007
• Start date: January 2000

Study information

• Verified date: September 2005
• Source: Chinese University of Hong Kong
• Contact: James YW Lau, MD, FRCS(Edin)
• Phone: (852)26322627
• Email: laujyw[@]netvigator.com
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Consented patients

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Obstruction
• Colorectal Cancer
• Colorectal Neoplasms
• Intestinal Obstruction

Intervention

Procedure:
• Endoscopic stenting followed by elective laparoscopic resection

Locations

Country	Name	City	State
China	Endoscopy Centre, Prince of Wales Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of relieving obstruction after stent insertion
Primary	The stoma rate in the two groups of patients
Secondary	Morbidity and mortality rates in the two groups
Secondary	Hospital stay