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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

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date August 7, 2007
Study Start Date  ICMJE January 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • The success rate of relieving obstruction after stent insertion
  • The stoma rate in the two groups of patients
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • The success rate of relieving obstruction after stent insertion.
  • The stoma rate in the two groups of patients.
Change History Complete list of historical versions of study NCT00164879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2007)
  • Morbidity and mortality rates in the two groups
  • Hospital stay
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Morbidity and mortality rates in the two groups.
  • Hospital stay.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
Official Title  ICMJE Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Bowel Obstruction
Intervention  ICMJE Procedure: Endoscopic stenting followed by elective laparoscopic resection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
70
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00164879
Other Study ID Numbers  ICMJE CRE-2002.445-T
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James YW Lau, MD, FRCS(Edin) Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP