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Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00164879
Enrollment
70
Registered
2005-09-14
Start date
2000-01-31
Completion date
Unknown
Last updated
2007-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Obstruction, Colorectal Cancer

Keywords

Obstructing, Left-sided, Colorectal neoplasms, Obstructing left-sided colorectal cancers

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.

Interventions

PROCEDUREEndoscopic stenting followed by elective laparoscopic resection

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The success rate of relieving obstruction after stent insertion
The stoma rate in the two groups of patients

Secondary

MeasureTime frame
Morbidity and mortality rates in the two groups
Hospital stay

Countries

China

Contacts

Primary ContactJames YW Lau, MD, FRCS(Edin)
laujyw@netvigator.com(852)26322627
Backup ContactSimon SM Ng, FRCS Ed (Gen)
simonng@surgery.cuhk.edu.hk(852)26322625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026