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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828318
• Other study ID #: MP-05-2019-1628
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Jewish General Hospital
• Contact: Aashiyan Singh, Msc(A)
• Phone: 514-340-8222
• Email: aashiyan.singh[@]ladydavis.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Anterior Resection
• Low Anterior Resection Syndrome
• Patient Activation
• Rectal Cancer
• Surgery
• Syndrome

Intervention

Other:
• Patient Activation Booklet and nursing support for patients with LARS
The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montréal	Quebec
Canada	CHU de Quebec	Québec	Quebec
Canada	Providence Healthcare	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Jewish General Hospital	Centre Hospitalier du Quebec, McGill University Health Centre/Research Institute of the McGill University Health Centre, Providence Healthcare, University of Manitoba

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global quality of life (QoL)	Measured by EORTC QLQ-C30	12 months