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

Last updated: November 26, 2024
Sponsor: Jewish General Hospital
Overall Status: Completed

Phase

N/A

Condition

Surgery

Colon Cancer

Rectal Disorders

Treatment

Patient Activation Booklet and nursing support for patients with LARS

Clinical Study ID

NCT03828318
MP-05-2019-1628
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Patient Activation Booklet and nursing support for patients with LARS
Phase:
Study Start date:
September 01, 2019
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • Providence Healthcare

    Vancouver, British Columbia
    Canada

    Site Not Available

  • University of Manitoba

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • McGill University Health Centre

    Montréal, Quebec
    Canada

    Site Not Available

  • CHU de Quebec

    Québec, Quebec
    Canada

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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