Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
Primary Purpose
Colorectal Cancer, Bowel Obstruction
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Endoscopic stenting followed by elective laparoscopic resection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Obstructing, Left-sided, Colorectal neoplasms, Obstructing left-sided colorectal cancers
Eligibility 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
Sites / Locations
- Endoscopy Centre, Prince of Wales HospitalRecruiting
Outcomes
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
Full Information
NCT ID
NCT00164879
First Posted
September 12, 2005
Last Updated
August 6, 2007
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164879
Brief Title
Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
Official Title
Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Bowel Obstruction
Keywords
Obstructing, Left-sided, Colorectal neoplasms, Obstructing left-sided colorectal cancers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Endoscopic stenting followed by elective laparoscopic resection
Primary Outcome Measure Information:
Title
The success rate of relieving obstruction after stent insertion
Title
The stoma rate in the two groups of patients
Secondary Outcome Measure Information:
Title
Morbidity and mortality rates in the two groups
Title
Hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James YW Lau, MD, FRCS(Edin)
Phone
(852)26322627
Email
laujyw@netvigator.com
First Name & Middle Initial & Last Name or Official Title & Degree
Simon SM Ng, FRCS Ed (Gen)
Phone
(852)26322625
Email
simonng@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James YW Lau, MD, FRCS(Edin)
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Centre, Prince of Wales Hospital
City
Hong Kong SAR
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James YW Lau, MD, FRCS(Edin)
Phone
(852)26322627
Email
laujyw@netvigator.com
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, FRCS Ed (Gen)
Phone
(852)26322625
Email
simonng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Simon SM Ng, FRCS Ed (Gen)
12. IPD Sharing Statement
Learn more about this trial
Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
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