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Colonic Stenting With Elective Surgery Versus Emergency Surgery in the Management of Acute Malignant Colonic Obstruction

NCT01997684 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-11-20

No results posted yet for this study

Summary

The use of colonic stenting with elective surgery has been suggested as an alternative management for acute malignant colonic obstruction, as emergency surgery has a high risk of morbidity and mortality.

However, the available body of literature addressing their benefit in this setting is contradictory.

The purpose of this study is to determine the efficacy and safety of colonic stenting with elective surgery versus emergency surgery in the management of acute malignant colonic obstruction.

Conditions

Interventions

PROCEDURE

Colonic Stenting with Elective Surgery

After preparation of the distal colon with an enema, the colonoscope will be introduced up to the site of the obstruction. The colonic stent will be placed along a guide wire through the lesion under radiologic or endoscopic guidance. A colonic stent will be chosen which was at least 3 cm longer than the lesion (1.5 cm at either end). When the colonic stent did not cover the entire length of the lesion, a second overlapping stent will be placed. If the colonic stenting failed (technical failure) or symptoms of colonic obstruction did not resolve within 3 days (clinical failure), patients were indicated for emergency surgery. Candidates for elective surgery were preferably operated on 5-14 days after colonic stenting, and no later than 4 weeks. Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.

PROCEDURE

Emergency Surgery

Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Side Liu, M.D. · Department of Gastroenterology, Nanfang Hospital, Southern Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997684 on ClinicalTrials.gov