Actively Recruiting
Randomised Clinical Investigation 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
N/A
Total Duration
On this page
Sponsors
Q
Qufora A/S
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of low volume Transanal Irrigation (TAI) using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome (LARS). This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups: one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy; and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires (EORTC QLQ-C30 and QLQ-CR29), incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.
CONDITIONS
Brief 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 electively treated for rectal cancer with a 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 a consequence
- Previous conservative treatments started for at least one month
- Able mentally and physically to handle the MiniGo device independently
- No signs of leakage or clinically relevant stenosis at the anastomosis
- Affiliated with 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 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 contributing diseases
- Cancer recurrence
- Life expectancy less than one year
- Participation in another clinical trial for LARS treatment
- Ongoing pelvic floor rehabilitation or biofeedback
- Pregnancy or planning pregnancy 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants who undergo routine care are observed to assess the effects of low volume transanal irrigation compared to standard conservative treatments for Low Anterior Resection Syndrome.
Visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months
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
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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