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

Jewish General Hospital

Status: Completed

Conditions: Low Anterior Resection; Patient Activation; Surgery; Low Anterior Resection Syndrome; Rectal Cancer

Treatments: Other: Patient Activation Booklet and nursing support for patients with LARS

Study type: Interventional

Funder types: Other

Identifiers

NCT03828318

MP-05-2019-1628

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Patient Activation Arm

Experimental group

Treatment:

Other: Patient Activation Booklet and nursing support for patients with LARS

Standard Care Arm

No Intervention group