Clinical trial NCT00164879: Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
Official title: Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Bowel Obstruction
Keywords: Obstructing
Left-sided
Colorectal neoplasms
Obstructing left-sided colorectal cancers
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The success rate of relieving obstruction after stent insertion
measure: The stoma rate in the two groups of patients
Secondary outcomes:
measure: Morbidity and mortality rates in the two groups
measure: Hospital stay
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Endoscopy Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: James YW Lau, MD, FRCS(Edin)
role: PRINCIPAL_INVESTIGATOR
References: