ClinicalTrials.gov
ClinicalTrials.gov Menu

Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00164879
Recruitment Status : Unknown
Verified September 2005 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : August 7, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Bowel Obstruction Procedure: Endoscopic stenting followed by elective laparoscopic resection Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial
Study Start Date : January 2000

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The success rate of relieving obstruction after stent insertion
  2. The stoma rate in the two groups of patients

Secondary Outcome Measures :
  1. Morbidity and mortality rates in the two groups
  2. Hospital stay


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164879


Contacts
Contact: James YW Lau, MD, FRCS(Edin) (852)26322627 laujyw@netvigator.com
Contact: Simon SM Ng, FRCS Ed (Gen) (852)26322625 simonng@surgery.cuhk.edu.hk

Locations
China
Endoscopy Centre, Prince of Wales Hospital Recruiting
Hong Kong SAR, China
Contact: James YW Lau, MD, FRCS(Edin)    (852)26322627    laujyw@netvigator.com   
Contact: Simon SM Ng, FRCS Ed (Gen)    (852)26322625    simonng@surgery.cuhk.edu.hk   
Sub-Investigator: Simon SM Ng, FRCS Ed (Gen)         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: James YW Lau, MD, FRCS(Edin) Chinese University of Hong Kong

ClinicalTrials.gov Identifier: NCT00164879     History of Changes
Other Study ID Numbers: CRE-2002.445-T
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: August 7, 2007
Last Verified: September 2005

Keywords provided by Chinese University of Hong Kong:
Obstructing
Left-sided
Colorectal neoplasms
Obstructing left-sided colorectal cancers

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Obstruction
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases