Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial

After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlates with worse perceived global health status and quality of life (QoL). Among patients undergoing rectal resection with a permanent ostomy, there is evidence that supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and knowledge. However, evidence regarding the impact of such interventions in patients who undergo restorative proctectomy is lacking, despite the latter operation being far more frequently performed.

The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy for rectal cancer.

This is a randomized-controlled muticenter trial that will include patients who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure.

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Key information

Conditions

Rectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Intestinal Diseases Intestinal Neoplasms Low Anterior Resection Low Anterior Resection Syndrome Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Activation Patient Participation Postoperative Complications Rectal Diseases Rectal Neoplasms Surgery Treatment Adherence and Compliance

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence Healthcare, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients (>=18 years-old) who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure

Exclusion criteria

Patients from whom clear and informed consent cannot be obtained
Patients unable to read and comprehend English or French
Patients who cannot be contacted by telephone
Patients who have undergone major colonic resection in addition to their proctectomy
Patients on active chemotherapy or radiotherapy treatment

Treatment and study plan

Patient Activation Booklet and nursing support for patients with LARS

Other

The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.

Primary outcomes

Global quality of life (QoL)

Time frame: 12 months

Measured by EORTC QLQ-C30

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Collaborators

Centre Hospitalier du Quebec
McGill University Health Centre/Research Institute of the McGill University Health Centre
Providence Healthcare
University of Manitoba

Registry information

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Feb 4, 2019
Registry last updated: Nov 29, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed