Is There a Link Between Anatomical Markers of Surgical Difficulty and Incapacity to Reverse Stoma After Low Rectal Cancer Surgery?

NCT ID: NCT04006600

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-16
• Study Completion Date: 2020-01-15

Brief Summary

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.

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.

Conditions

Rectal Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Sphincter saving proctectomy

After rectal resection, when colorectal anastomosis is subperitoneal, it is currently recommended to perform a protective stoma to reduce the potential consequences of a fistula. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature.

The objective of the study is therefore to look for a statistical link between the persistence of a permanent stoma and the intraoperative difficulty represented by pelvic anatomical stress.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin BERTRAND

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Locations

Nimes University Hospital

Nîmes, , France

Countries

France

Other Identifiers

Local 2018/MB-02

Identifier Type: -

Identifier Source: org_study_id