University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Completed
NCT Number: NCT04246775
Low Anterior Resection Syndrome and Rectal Irrigation Study
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Peristeen
Devicerectal irrigation
Primary outcomes
-
SF12
Time frame: pre intervention and 6 months post
quality of life
Secondary outcomes
-
EORTC
Time frame: pre intervention and 6 months post
quality of life
-
Low anterior resection score
Time frame: pre intervention and 6 months post
bowel function
-
St Marks Faecal incontinence score
Time frame: pre intervention and 6 months post
bowel function
-
treatment acceptability questionnaire
Time frame: post training for treatment and 6 months post treatment
Other outcomes
-
qualitative interviews
Time frame: after 6 months treatment or drop out from treatment group
Sponsors and collaborators
Lead sponsor
Cardiff and Vale University Health Board
Other Gov
Collaborators
- South East Wales Trials Unit (SEWTU)
- Tenovus
Registry information
Acronym: LARRIS
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jan 29, 2020
- Registry last updated
- Jan 29, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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