Status:
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
Lead Sponsor:
Qufora A/S
Collaborating Sponsors:
EVAMED
Conditions:
Gastroenterology
LARS - Low Anterior Resection Syndrome
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Adult aged from 18 years
- Patients electively treated for rectal cancer with a low anterior resection
- Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
- LARS score \>= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
- Adult for whom previous conservative treatments were started for at least a month
- Mental and physical capability of the patient to handle the MiniGo by himself.
- Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice
- Patient affiliated to the health social security system
Exclusion
- Contra-indication to use TAI
- Former use of TAI (post colo-rectal surgery)
- Clinically relevant stenosis
- Current metastatic disease or local recurrence
- Ongoing chemotherapy
- Postoperative radiotherapy for rectal cancer
- History of diarrhoeal disease
- Inflammatory bowel disease
- Dementia
- Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
- Patient with cancer recurrence
- Patient with a life expectancy \< 1 year
- Participating to another clinical trial for the treatment of LARS symptom
- Ongoing pelvic floor rehabilitation/biofeedback
- Pregnancy or intention to become pregnant during the trial period
- Inability and unwillingness to give informed consent
Key Trial Info
Start Date :
June 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06923150
Start Date
June 18 2024
End Date
December 1 2026
Last Update
April 11 2025
Active Locations (9)
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1
CHU Amiens-Picardie
Amiens, France, 80054
2
CHU Besançon
Besançon, France, 25030
3
Clinique Tivoli-Ducos
Bordeaux, France, 33000
4
CHU Grenoble
La Tronche, France, 38700