Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection for Rectal Cancer

Safeheal8 sites in 2 countries372 target enrollmentApril 1, 2020

ConditionsRectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Safeheal
Enrollment: 372
Locations: 8
Primary Endpoint: Surgical complications
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer. The data from this retrospective study will be analyzed by the study Sponsor to aid in designing a prospective clinical trial for a new technology that offers a treatment alternative to standard of care defunctioning stoma in patients undergoing LAR for rectal cancer.

Registry

clinicaltrials.gov

Start Date

April 1, 2020

End Date

May 1, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Safeheal

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults, 18 years of age or older at the time the LAR surgery was performed.
•Having an open or minimally invasive colorectal resection with diverting loop ileostomy surgical procedure performed between January 15, 2015 and January 15, 2019 for treatment of a known or suspected malignant condition.
•Availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the LAR surgery.

Exclusion Criteria

•Planned surgical procedure is a Hartmann's procedure (surgical resection of the rectosigmoid colon with closure of the anorectal stump and formation of an end colostomy).
•Having a documented medical history of inflammatory bowel disease prior to the LAR surgery.
•Having a concomitant major surgical procedure performed in combination with the LAR surgery (e.g., colorectal resection with hepatectomy).

Outcomes

Primary Outcomes

Surgical complications

Time Frame: 12 Months

Characterize the type and incidence of surgical complications related to the LAR, the stoma creation and the stoma reversal after LAR for rectal cancer.