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

May 6, 2021 updated by: Safeheal

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 2R5
        • Lawson Health Research Institute
  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of USC
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial
    • New York
      • New Hyde Park, New York, United States, 11042
        • Northwell Health, Inc.
      • New York, New York, United States, 10029
        • Icahn School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent LAR for rectal cancer and are 12 months or longer postoperative from the LAR surgery will be reviewed for eligibility.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
LAR for rectal cancer
Retrospective chart review for surgical complications related to the LAR surgery, the stoma (diverting loop ileostomy) creation and the stoma reversal procedure after LAR for rectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications
Time Frame: 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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Safeheal

Collaborators

Clinical Research Consultants, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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