Low Anterior Resection Syndrome and Rectal Irrigation Study

NCT ID: NCT04246775

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

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Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function.

Detailed Description

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Aims: To assess if rectal irrigation improves patient symptoms and quality of life in patients with LARS and to see if the treatment is acceptable to patients.

Methods: This is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between Jan 2009 and Jan 2014. Those patients deemed to have LARS who consent to participation in the study will be offered rectal irrigation.

Conditions

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Anterior Resection Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Peristeen given

Group Type OTHER

Peristeen

Intervention Type DEVICE

rectal irrigation

Interventions

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Peristeen

rectal irrigation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity
* LARS score of \>20 (defined LARS syndrome)
* patients \> 18 years of age.

Exclusion Criteria

* previous use of rectal irrigation
* patients who are unable to give informed consent
* patients who are not physically capable of performing the treatment in their home
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South East Wales Trials Unit (SEWTU)

UNKNOWN

Sponsor Role collaborator

Tenovus

UNKNOWN

Sponsor Role collaborator

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NIHR/UKCRN Portfolio ID: 18113

Identifier Type: -

Identifier Source: org_study_id

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