Low Anterior Resection Syndrome and Rectal Irrigation Study

Not Applicable

Completed

• Conditions: Anterior Resection Syndrome
• Interventions: Device: Peristeen

• Registration Number: NCT04246775
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-02
• Study First Submitted: 2015-02-10
• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Study First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Study First Posted: 2020-01-29
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Peristeen	Peristeen given

Primary Outcome Measures

Name	Time	Method
SF12	pre intervention and 6 months post	quality of life

Secondary Outcome Measures

Name	Time	Method
treatment acceptability questionnaire	post training for treatment and 6 months post treatment
EORTC	pre intervention and 6 months post	quality of life
St Marks Faecal incontinence score	pre intervention and 6 months post	bowel function
Low anterior resection score	pre intervention and 6 months post	bowel function

Trial Locations

Locations (1)

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom