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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359498
• Other study ID #: SH-001
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Safeheal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario
United States	University of California, Irvine	Irvine	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck School of Medicine of USC	Los Angeles	California
United States	Northwell Health, Inc.	New Hyde Park	New York
United States	Icahn School of Medicine	New York	New York
United States	University of South Florida	Tampa	Florida
United States	UMASS Memorial	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Safeheal	Clinical Research Consultants, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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