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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04359498

Enrollment

372

Registered

2020-04-24

Start date

2020-04-01

Completion date

2021-05-01

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Low Anterior Resection

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Surgical complications	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.

Countries

Canada, United States

Outcome results