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

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT04359498
• Lead Sponsor: Safeheal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Status Verified: 2021-05
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

1. Adults, 18 years of age or older at the time the LAR surgery was performed.
2. 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.
3. Availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the LAR surgery.

Exclusion Criteria

1. 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).
2. Having a documented medical history of inflammatory bowel disease prior to the LAR surgery.
3. Having a concomitant major surgical procedure performed in combination with the LAR surgery (e.g., colorectal resection with hepatectomy).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical complications	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.

Trial Locations

Locations (8)

Northwell Health, Inc.; 🇺🇸 New Hyde Park, New York, United States

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UMASS Memorial; 🇺🇸 Worcester, Massachusetts, United States

Icahn School of Medicine; 🇺🇸 New York, New York, United States

Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada

University of South Florida; 🇺🇸 Tampa, Florida, United States