- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04006600
Is There a Link Between Anatomical Markers of Surgical Difficulty and Incapacity to Reverse Stoma After Low Rectal Cancer Surgery? (persist stomie)
June 18, 2021 updated by: Centre Hospitalier Universitaire de Nīmes
Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers .
A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity.
This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature.
The main risk factor being anastomotic leakage.
Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers .
A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity.
This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature.
The main risk factor being anastomotic leakage.
Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Studies focused on surgical difficulties usually evaluated criteria such as, total surgery duration, blood loss or surgeon's subjective evaluation.
The investigators of this retrospective study hypothesize that when a stoma,primarily intended to be temporary, is not reversed after a long (2 years) post operative delay, it all comes to surgical difficulties and that these surgical difficulties are essentially represented by anatomical constraints.
Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France
- Nîmes University Hospital
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-
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
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients who underwent a cancer proctectomy with sphincter conservation
Description
Inclusion Criteria:
- Adult patients who underwent a sphincter saving resection for low rectal cancer between January 2019 and December 2017.
Exclusion Criteria:
- Minor patients.
- Patients who have undergone a cancer proctectomy with no restoration of continuity expected.
- Patients who did not have total Mesorectal excision
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistence of a stomy 2 years after rectal surgery when stoma was primarily intended to be temporary
Time Frame: 2 years
|
Number of patient with the persistence of a permanent stoma
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin BERTRAND, Nîmes University Hospital
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 (ACTUAL)
March 16, 2018
Primary Completion (ACTUAL)
January 15, 2020
Study Completion (ACTUAL)
January 15, 2020
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 2, 2019
First Posted (ACTUAL)
July 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2021
Last Update Submitted That Met QC Criteria
June 18, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Local 2018/MB-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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