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Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

NCT ID: NCT00164879

Last Updated: 2007-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Bowel Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Endoscopic stenting followed by elective laparoscopic resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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James YW Lau, MD, FRCS(Edin)

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Endoscopy Centre, Prince of Wales Hospital

Hong Kong SAR, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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James YW Lau, MD, FRCS(Edin)

Role: CONTACT

[email protected]
(852)26322627

Simon SM Ng, FRCS Ed (Gen)

Role: CONTACT

[email protected]
(852)26322625

Facility Contacts

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James YW Lau, MD, FRCS(Edin)

Role: primary

[email protected]
(852)26322627

Simon SM Ng, FRCS Ed (Gen)

Role: backup

[email protected]
(852)26322625

Other Identifiers

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CRE-2002.445-T

Identifier Type: -

Identifier Source: org_study_id