Clinical trial NCT06923150: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroenterology
LARS - Low Anterior Resection Syndrome
Rectal Cancer
Keywords: LARS
Transanal Irrigation
Minigo
rectal cancer
Lead sponsor: Qufora A/S
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2025-04-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: minor and major LARS patients LARS score \>= 25

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.


Eligibility criteria: Inclusion Criteria:

1. Adult aged from 18 years
2. Patients electively treated for rectal cancer with a low anterior resection
3. Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
4. 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)
5. Adult for whom previous conservative treatments were started for at least a month
6. Mental and physical capability of the patient to handle the MiniGo by himself.
7. 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
8. Patient affiliated to the health social security system

Exclusion Criteria:

1. Contra-indication to use TAI
2. Former use of TAI (post colo-rectal surgery)
3. Clinically relevant stenosis
4. Current metastatic disease or local recurrence
5. Ongoing chemotherapy
6. Postoperative radiotherapy for rectal cancer
7. History of diarrhoeal disease
8. Inflammatory bowel disease
9. Dementia
10. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
11. Patient with cancer recurrence
12. Patient with a life expectancy \< 1 year
13. Participating to another clinical trial for the treatment of LARS symptom
14. Ongoing pelvic floor rehabilitation/biofeedback
15. Pregnancy or intention to become pregnant during the trial period
16. Inability and unwillingness to give informed consent

Primary outcomes:
measure: LARS score difference
timeFrame: 3-month follow-up
Secondary outcomes:
measure: efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks
timeFrame: 6-week follow-up
measure: QoL with the EORTC QLQ-C30 EORTC QLQ-CR29
timeFrame: 3-month follow- up
measure: change (reduction) of symptoms and consequences
timeFrame: 6 weeks and 12 weeks
measure: patient satisfaction
timeFrame: 6 weeks and 12 weeks
measure: compliance of the patient to the treatmen
timeFrame: 6 weeks and 12 weeks
measure: incontinence anal score
timeFrame: 12 weeks
measure: reduction of defecations per day and night
timeFrame: 6 weeks and 12 weeks
measure: time spent on bowel management (in the toilets room)
timeFrame: 12 weeks
measure: patient health organization and resources needed
timeFrame: 12 weeks
measure: improving the LARS score
timeFrame: 6, 9 and 12 months
measure: number of patients showing a change (reduction) of symptoms and consequences
timeFrame: 6, 9 and 12 months
measure: Preference of the patient and reason for it
timeFrame: 12 month follow-up
measure: QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month
timeFrame: 12-month follow-up
measure: incontinence anal score at 12 months
timeFrame: 12-month follow-up
measure: patient health organization and resources needed at 6, 9 and 12 months
timeFrame: 6, 9 and 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: La Tronche
country: France
facility: CHU Grenoble
city: Marseille
country: France
facility: CHU Timone
city: Nantes
country: France
facility: CHU de NANTES, Hôtel Dieu
city: Pessac
country: France
facility: CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
city: Pierre-benite
country: France
facility: CH Lyon Sud
city: Rouen
country: France
facility: CHU Charles Nicolle - Rouen
Study officials:
References: