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

Last updated: May 6, 2021
Sponsor: Safeheal
Overall Status: Completed

Phase

N/A

Condition

Rectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT04359498
SH-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 loopileostomy surgical procedure performed between January 15, 2015 and January 15, 2019for treatment of a known or suspected malignant condition.
  3. Availability of medical records for a postoperative visit occurring 12 months (± 3months) after the LAR surgery.

Exclusion

Exclusion Criteria:

  1. Planned surgical procedure is a Hartmann's procedure (surgical resection of therectosigmoid colon with closure of the anorectal stump and formation of an endcolostomy).
  2. Having a documented medical history of inflammatory bowel disease prior to the LARsurgery.
  3. Having a concomitant major surgical procedure performed in combination with the LARsurgery (e.g., colorectal resection with hepatectomy).

Study Design

Total Participants: 372
Study Start date:
April 01, 2020
Estimated Completion Date:
May 01, 2021

Connect with a study center

  • Lawson Health Research Institute

    London, Ontario N6C 2R5
    Canada

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • UMASS Memorial

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Northwell Health, Inc.

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Icahn School of Medicine

    New York, New York 10029
    United States

    Site Not Available

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