Low Anterior Resection Syndrome and Rectal Irrigation Study (LARRIS)

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.

Study Overview

• Status: Completed
• Conditions: Anterior Resection Syndrome
• Intervention / Treatment: Device: Peristeen

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; Peristeen given	Device: Peristeen; rectal irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF12	quality of life	pre intervention and 6 months post

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
qualitative interviews	after 6 months treatment or drop out from treatment group

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: South East Wales Trials Unit (SEWTU); Tenovus

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: NIHR/UKCRN Portfolio ID: 18113