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NCT Number: NCT04359498

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lawson Health Research Institute, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Safeheal

Industry

Collaborators

  • Clinical Research Consultants, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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