Status:
COMPLETED
Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)
Lead Sponsor:
Safeheal
Collaborating Sponsors:
Clinical Research Consultants, Inc.
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
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 retrospec...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT04359498
Start Date
April 1 2020
End Date
May 1 2021
Last Update
May 10 2021
Active Locations (8)
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1
University of California, Irvine
Irvine, California, United States, 92697
2
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
University of South Florida
Tampa, Florida, United States, 33606