NCT00514332

Brief Summary

To evaluate wether colorectal stenting carry a significant clinical advantage

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
Last Updated

August 9, 2007

Status Verified

August 1, 2007

First QC Date

August 8, 2007

Last Update Submit

August 8, 2007

Conditions

Colorectal ObstructionLeft Colonic Adenocarcinoma

Keywords

colorectal stentscolonic obstructioncolonic adenocarcinomacolorectal surgery

Outcome Measures

Primary Outcomes (1)

  • number of stoma in each group

    within the first 6 month(plus or minus 1 month) after surgery

Secondary Outcomes (4)

  • mortality in each group

    within the first 6 month (plus or minus 1 month) after surgery

  • complications

    within the first 6 month (plus or minus 1 month) after surgery

  • number of procedures

    within the first 6 month (plus or minus 1 month) after surgery

  • length of stay

    within the first 6 month (plus or minus 1 month) after surgery

Study Arms (1)

A

EXPERIMENTAL

primary surgery group

Procedure: stent

Interventions

stentPROCEDURE

stent placement for colorectal cancer obstruction

Also known as: self-expending metallic stents
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obstructive stenosis due to left colorectal cancer

You may not qualify if:

  • previous colorectal cancer
  • other colorectal location

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.

    PMID: 21170659DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Stents

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Bertrand L MILLAT, MD-PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

December 1, 2002

Study Completion

October 1, 2006

Last Updated

August 9, 2007

Record last verified: 2007-08