Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

August 8, 2007 updated by: University Hospital, Montpellier

Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial

To evaluate wether colorectal stenting carry a significant clinical advantage

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obstructive stenosis due to left colorectal cancer

Exclusion Criteria:

  • previous colorectal cancer
  • other colorectal location

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
primary surgery group
Procedure: stent
stent placement for colorectal cancer obstruction
Other Names:
  • self-expending metallic stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of stoma in each group
Time Frame: within the first 6 month(plus or minus 1 month) after surgery
within the first 6 month(plus or minus 1 month) after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality in each group
Time Frame: within the first 6 month (plus or minus 1 month) after surgery
within the first 6 month (plus or minus 1 month) after surgery
complications
Time Frame: within the first 6 month (plus or minus 1 month) after surgery
within the first 6 month (plus or minus 1 month) after surgery
number of procedures
Time Frame: within the first 6 month (plus or minus 1 month) after surgery
within the first 6 month (plus or minus 1 month) after surgery
length of stay
Time Frame: within the first 6 month (plus or minus 1 month) after surgery
within the first 6 month (plus or minus 1 month) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

University Hospital, Angers
University Hospital, Rouen
University Hospital, Bordeaux
University Hospital, Grenoble
Rennes University Hospital
University Hospital, Toulouse
University Hospital, Lille

Investigators

  • Principal Investigator: Bertrand L MILLAT, MD-PhD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 9, 2007

Last Update Submitted That Met QC Criteria

August 8, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF7683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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