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

This study has been terminated.

( enrolling participants stopped )

First Received: August 8, 2007 No Changes Posted

Sponsors and Collaborators:	University Hospital, Montpellier University Hospital, Rouen University Hospital, Toulouse University Hospital, Grenoble Rennes University Hospital University Hospital, Lille University Hospital, Angers University Hospital, Bordeaux
Information provided by:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT00514332

Purpose

To evaluate wether colorectal stenting carry a significant clinical advantage

Condition	Intervention
Colorectal Obstruction Left Colonic Adenocarcinoma	Procedure: stent

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:

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

Secondary Outcome Measures:

mortality in each group [ Time Frame: 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 ]
number of procedures [ Time Frame: 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 ]

Enrollment:	70
Study Start Date:	December 2002
Study Completion Date:	October 2006

Arms	Assigned Interventions
A: Experimental primary surgery group	Procedure: stent stent placement for colorectal cancer obstruction

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

obstructive stenosis due to left colorectal cancer

Exclusion Criteria:

previous colorectal cancer
other colorectal location

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514332

Sponsors and Collaborators

University Hospital, Montpellier

University Hospital, Rouen

University Hospital, Toulouse

University Hospital, Grenoble

Rennes University Hospital

University Hospital, Lille

University Hospital, Angers

University Hospital, Bordeaux

Investigators

Principal Investigator:

Bertrand L MILLAT, MD-PhD

University Hospital, Montpellier

More Information

No publications provided

Study ID Numbers:	UF7683
Study First Received:	August 8, 2007
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00514332 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Montpellier:

colorectal stents
colonic obstruction
colonic adenocarcinoma
colorectal surgery

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases

Adenocarcinoma
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Neoplasms
Carcinoma
Neoplasms

Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colonic Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 04, 2009