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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No