Actively Recruiting
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
Led by Qufora A/S · Updated on 2025-04-11
78
Participants Needed
9
Research Sites
128 weeks
Total Duration
On this page
Sponsors
Q
Qufora A/S
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients treated electively for rectal cancer with low anterior resection
- Between 3 and 18 months after colorectal surgery or stoma reversal
- LARS score of 25 or higher with at least one symptom causing one consequence
- Started previous conservative treatments for at least one month
- Mentally and physically capable of handling the MiniGo device independently
- No signs of anastomosis leakage or clinically relevant stenosis, and no local recurrence confirmed by exam
- Affiliated to a health social security system
You will not qualify if you...
- Contraindication to use Transanal Irrigation (TAI)
- Previous use of TAI after colorectal surgery
- Clinically relevant stenosis
- Current metastatic disease or local cancer recurrence
- Ongoing chemotherapy
- Postoperative radiotherapy for rectal cancer
- History of diarrheal disease
- Inflammatory bowel disease
- Dementia
- Spinal cord injury, multiple sclerosis, Parkinson's disease, or other significant diseases causing LARS symptoms
- Cancer recurrence
- Life expectancy less than 1 year
- Participation in another clinical trial for LARS treatment
- Ongoing pelvic floor rehabilitation or biofeedback
- Pregnancy or planning to become pregnant during the trial
- Unable or unwilling to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
CHU Amiens-Picardie
Amiens, France, 80054
Actively Recruiting
2
CHU Besançon
Besançon, France, 25030
Actively Recruiting
3
Clinique Tivoli-Ducos
Bordeaux, France, 33000
Actively Recruiting
4
CHU Grenoble
La Tronche, France, 38700
Actively Recruiting
5
CHU Timone
Marseille, France, 13005
Not Yet Recruiting
6
CHU de NANTES, Hôtel Dieu
Nantes, France, 44093
Actively Recruiting
7
CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
Pessac, France, 33604
Not Yet Recruiting
8
CH Lyon Sud
Pierre-Bénite, France, 69495
Not Yet Recruiting
9
CHU Charles Nicolle - Rouen
Rouen, France, 76 031
Actively Recruiting
Research Team
R
Rogini Balachandran
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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