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Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Bowel Obstruction

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Trial Information

Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The success rate of relieving obstruction after stent insertion

Principal Investigator

James YW Lau, MD, FRCS(Edin)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong

Authority:

Hong Kong: Department of Health

Study ID:

CRE-2002.445-T

NCT ID:

NCT00164879

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Bowel Obstruction
  • Obstructing
  • Left-sided
  • Colorectal neoplasms
  • Obstructing left-sided colorectal cancers
  • Colorectal Neoplasms
  • Intestinal Obstruction

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