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Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Unknown
Phase 3

Conditions

Bowel Obstruction
Colorectal Cancer

Treatments

Procedure: Endoscopic stenting followed by elective laparoscopic resection

Study type

Interventional

Funder types

Other

Identifiers

NCT00164879
CRE-2002.445-T

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

James YW Lau, MD, FRCS(Edin); Simon SM Ng, FRCS Ed (Gen)

Data sourced from clinicaltrials.gov

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