Low Anterior Resection Syndrome and Rectal Irrigation Study | NCT04246775

Studies
Low Anterior Resection Syndrome and Rectal Irrigation Study

NCT04246775

Sponsor

Cardiff and Vale University Health Board

Status

Completed

Last Update Posted

Jan 29, 2020Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Anterior Resection Syndrome

Interventions

Peristeen

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2020

Last Update Posted Date

Jan 29, 2020Actual

Name	Class
South East Wales Trials Unit (SEWTU)	UNKNOWN
Tenovus	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Other	Peristeen given	Device: Peristeen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peristeen	Device	rectal irrigation	Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
EORTC	quality of life	pre intervention and 6 months post
Low anterior resection score	bowel function	pre intervention and 6 months post

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Wales		Cardiff		CF14 4XW	United Kingdom