NCT04246775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

February 10, 2015

Last Update Submit

January 28, 2020

Conditions

Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

  • SF12

    quality of life

    pre intervention and 6 months post

Secondary Outcomes (4)

  • EORTC

    pre intervention and 6 months post

  • Low anterior resection score

    pre intervention and 6 months post

  • St Marks Faecal incontinence score

    pre intervention and 6 months post

  • treatment acceptability questionnaire

    post training for treatment and 6 months post treatment

Other Outcomes (1)

  • qualitative interviews

    after 6 months treatment or drop out from treatment group

Study Arms (1)

Treatment

OTHER

Peristeen given

Device: Peristeen

Interventions

PeristeenDEVICE

rectal irrigation

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

January 29, 2020

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

January 29, 2020

Record last verified: 2015-02

Locations

GB(1)