Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)

Completed

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT04359498

Run by

Safeheal

People needed

372

Starts

2020-04-01

Expected to finish

2021-05-01

Last updated by the study team

2021-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of California, Irvine — Irvine, California, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of South Florida — Tampa, Florida, United States
• UMASS Memorial — Worcester, Massachusetts, United States
• Northwell Health, Inc. — New Hyde Park, New York, United States
• Icahn School of Medicine — New York, New York, United States
• Lawson Health Research Institute — London, Ontario, Canada

Full record on ClinicalTrials.gov

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