Observational Recruiting
NCT06923150 on ClinicalTrials.gov
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
- Sponsor: Qufora A/S
- Collaborators: EVAMED
- Enrollment: 78 (Estimated)
- Study start: 2024-06-18 (Actual)
- Primary completion: 2026-12-01 (Estimated)
- Study completion: 2026-12-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief Summary
The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.
Conditions
- Gastroenterology
- LARS - Low Anterior Resection Syndrome
- Rectal Cancer
Primary Outcome Measures
-
LARS score difference
(3-month follow-up)
The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.
Countries
France
Locations and Investigators
- CHU Amiens-Picardie, Amiens, France (Recruiting)
- CHU Besançon, Besançon, France (Recruiting)
- Clinique Tivoli-Ducos, Bordeaux, France (Recruiting)
- CHU Grenoble, La Tronche, France (Recruiting)
- CHU Timone, Marseille, France (Not yet recruiting)
- CHU de NANTES, Hôtel Dieu, Nantes, France (Recruiting)
-
CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE, Pessac, France (Not yet recruiting)
- Benjamin FERNANDEZ
- CH Lyon Sud, Pierre-benite, France (Not yet recruiting)
- CHU Charles Nicolle - Rouen, Rouen, France (Recruiting)