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

Completed · Not applicable

Conditions studied: Rectal Cancer, Surgery, Patient Activation, Low Anterior Resection, Low Anterior Resection Syndrome

In brief

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.

Key facts

Study ID

NCT03828318

Run by

Jewish General Hospital

People needed

160

Starts

2019-09-01

Expected to finish

2024-01-31

Last updated by the study team

2024-11-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Providence Healthcare — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• CHU de Quebec — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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