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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
Chinese University of Hong Kong
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
August 6, 2007
Sponsor
Chinese University of Hong Kong
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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

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Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

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