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
About this study
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.
- Condition
- Gastroenterology, LARS - Low Anterior Resection Syndrome, Rectal Cancer
- Sponsor
- Qufora A/S
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Study condition: Gastroenterology, LARS - Low Anterior Resection Syndrome, Rectal Cancer
- 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 16
- 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
Where
9 sites, 9 recruiting
CHU Amiens-Picardie
Amiens, France
CHU Besançon
Besançon, France
Clinique Tivoli-Ducos
Bordeaux, France
CHU Grenoble
La Tronche, France
CHU de NANTES, Hôtel Dieu
Nantes, France
CHU Charles Nicolle - Rouen
Rouen, France
and 3 more sites on ClinicalTrials.gov
Contact
-
Rogini Balachandran
+ 45 42 40 06 20 rob@qufora.com
Potential match only. Final eligibility is determined by the study team.