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Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study

NCT05319054 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2023-07-20

No results posted yet for this study

Summary

Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial.

Conditions

  • Low Anterior Resection Syndrome

Interventions

DEVICE

Sacral NeuroModulation

Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.

DEVICE

Trans-Anal Irrigation

Trans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference.

OTHER

Optimised Conservative Management

Optimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently.

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • Aneurin Bevan University Health Board

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Bowel Research UK

    collaborator UNKNOWN

  • The Leeds Teaching Hospitals NHS Trust

    collaborator OTHER

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Principal Investigators

  • Julie A Cornish · Cardiff and Vale University Health Board

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319054 on ClinicalTrials.gov