Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Alessio Pigazzi, MD

Description

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.

Official Title

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

Keywords

Rectal Cancer Low Anterior Resection Rectal Neoplasms LAR for rectal cancer

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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).

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States
  • Keck School of Medicine of USC accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Irvine

  • Alessio Pigazzi, MD
    Clinical Professor, Surgery. Authored (or co-authored) 154 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Safeheal
ID
NCT04359498
Study Type
Observational
Last Updated