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Randomized Clinical Trial on Transanal Irrigation

NCT04586634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-22

Study results available
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Summary

Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care.

The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter.

Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy.

The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site.

Primary endpoint and secondary endpoints

Primary endpoint:

• LARS score, obtained from the LARS score questionnaire\*

Secondary endpoints:

* Number of subjects with Major LARS\*
* FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\*
* FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\*
* FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\*
* FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\*
* EQ-5D-5L - utility score\*
* EQ-5D-5L - VAS score (scale 0-10 cm)\*
* Satisfaction with treatment (scale 0-10 cm)\*
* Number of adverse events\* \*All endpoints are measured per subject at study completion

Conditions

  • Low Anterior Resection Syndrome

Interventions

DEVICE

Peristeen cone catheter

The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Guillaume Meurette, MD · CHU Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2021-12-10
Completion
2021-12-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586634 on ClinicalTrials.gov