Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00164879
First received: September 12, 2005
Last updated: August 6, 2007
Last verified: September 2005
  Purpose

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 Intervention Phase
Colorectal Cancer
Bowel Obstruction
Procedure: Endoscopic stenting followed by elective laparoscopic resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

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

Secondary Outcome Measures:
  • Morbidity and mortality rates in the two groups
  • Hospital stay

Estimated Enrollment: 70
Study Start Date: January 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164879     History of Changes
Other Study ID Numbers: CRE-2002.445-T
Study First Received: September 12, 2005
Last Updated: August 6, 2007
Health Authority: Hong Kong: Department of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014