Low Anterior Resection Syndrome and Rectal Irrigation Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04246775

Acronym

LARRIS

Enrollment

Registered

2020-01-29

Start date

2015-04-30

Completion date

2016-07-31

Last updated

2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Resection Syndrome

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.

Interventions

DEVICEPeristeen

rectal irrigation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026