We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(enrolling participants stopped)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514332
First Posted: August 9, 2007
Last Update Posted: August 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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
Experimental: A
primary surgery group
Procedure: stent
stent placement for colorectal cancer obstruction
Other Name: self-expending metallic stents

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00514332     History of Changes
Other Study ID Numbers: UF7683
First Submitted: August 8, 2007
First Posted: August 9, 2007
Last Update Posted: August 9, 2007
Last Verified: August 2007

Keywords provided by University Hospital, Montpellier:
colorectal stents
colonic obstruction
colonic adenocarcinoma
colorectal surgery

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms