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

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    128
  • sponsor
    Jewish General Hospital
Updated on 4 October 2022
cancer
rectal carcinoma
low anterior resection
proctectomy

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.

Details
Condition Rectal Cancer, Surgery, Patient Activation, Low Anterior Resection, Low Anterior Resection Syndrome
Treatment Patient Activation Booklet and nursing support for patients with LARS
Clinical Study IdentifierNCT03828318
SponsorJewish General Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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