Low Anterior Resection Syndrome and Rectal Irrigation Study

Anterior Resection Syndrome Clinical Trial

— LARRIS  

Official title:

Low Anterior Resection Syndrome and Rectal Irrigation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246775
• Other study ID #: NIHR/UKCRN Portfolio ID: 18113
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: February 2015
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Resection Syndrome
• Syndrome

Intervention

Device:
• Peristeen
rectal irrigation

Locations

Country	Name	City	State
United Kingdom	University Hospital of Wales	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	South East Wales Trials Unit (SEWTU), Tenovus

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	qualitative interviews		after 6 months treatment or drop out from treatment group
Primary	SF12	quality of life	pre intervention and 6 months post
Secondary	EORTC	quality of life	pre intervention and 6 months post
Secondary	Low anterior resection score	bowel function	pre intervention and 6 months post
Secondary	St Marks Faecal incontinence score	bowel function	pre intervention and 6 months post
Secondary	treatment acceptability questionnaire		post training for treatment and 6 months post treatment