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Low Anterior Resection Syndrome and Rectal Irrigation Study (LARRIS)

C

Cardiff and Vale University Health Board

Status

Completed

Conditions

Anterior Resection Syndrome

Treatments

Device: Peristeen

Study type

Interventional

Funder types

Other

Identifiers

NCT04246775
NIHR/UKCRN Portfolio ID: 18113

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Treatment
Other group
Description:
Peristeen given
Treatment:
Device: Peristeen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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