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

NCT04359498 | Completed

• 1 other identifier: SH-001
• Study Type: observational
• Target: 372
• Locations: 2 countries
• Sites: 8

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.

Conditions

Rectal Cancer

Keywords

Low Anterior Resection

Outcome Measures

Primary Outcomes (1)

• Surgical complications

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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).

Sponsors & Collaborators

• Safeheal: lead
• Clinical Research Consultants, Inc.: collaborator

Study Sites (8)

University of California, Irvine

Irvine, California, 92697, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

UMASS Memorial

Worcester, Massachusetts, 01605, United States

Location

Northwell Health, Inc.

New Hyde Park, New York, 11042, United States

Location

Icahn School of Medicine

New York, New York, 10029, United States

Location

Lawson Health Research Institute

London, Ontario, N6C 2R5, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: April 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (7)