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

NCT04006600 | Completed

• 1 other identifier: Local 2018/MB-02
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Surgery

Outcome Measures

Primary Outcomes (1)

• Persistence of a stomy 2 years after rectal surgery when stoma was primarily intended to be temporary

  Number of patient with the persistence of a permanent stoma

  2 years

Interventions

Sphincter saving proctectomy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who underwent a cancer proctectomy with sphincter conservation

You may qualify if:

• Adult patients who underwent a sphincter saving resection for low rectal cancer between January 2019 and December 2017.

You may not qualify if:

• Minor patients.
• Patients who have undergone a cancer proctectomy with no restoration of continuity expected.
• Patients who did not have total Mesorectal excision

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, France

Location

Study Officials

• Martin BERTRAND

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: March 16, 2018
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

FR (1)