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

Colorectal Obstruction Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00514332
• Other study ID #: UF7683
• Status: Terminated
• Phase: N/A
• First received: August 8, 2007
• Last updated: August 8, 2007
• Start date: December 2002
• Est. completion date: October 2006

Study information

• Verified date: August 2007
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate wether colorectal stenting carry a significant clinical advantage

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• obstructive stenosis due to left colorectal cancer

Exclusion Criteria:

• previous colorectal cancer

• other colorectal location

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Obstruction
• Left Colonic Adenocarcinoma

Intervention

Procedure:
• stent
stent placement for colorectal cancer obstruction

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Rennes University Hospital, University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Rouen, University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of stoma in each group		within the first 6 month(plus or minus 1 month) after surgery
Secondary	mortality in each group		within the first 6 month (plus or minus 1 month) after surgery
Secondary	complications		within the first 6 month (plus or minus 1 month) after surgery
Secondary	number of procedures		within the first 6 month (plus or minus 1 month) after surgery
Secondary	length of stay		within the first 6 month (plus or minus 1 month) after surgery