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
| NCT ID | NCT06923150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qufora A/S |
| Condition | Gastroenterology |
| Study Type | OBSERVATIONAL |
| Enrollment | 78 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 78 participants in total. It began in 2024-06-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06923150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroenterology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06923150 currently recruiting?
Yes, NCT06923150 is actively recruiting participants. Contact the research team at rob@qufora.com for enrollment information.
Where is the NCT06923150 trial being conducted?
This trial is being conducted at Amiens, France, Besançon, France, Bordeaux, France, La Tronche, France and 5 additional locations.
Who is sponsoring the NCT06923150 clinical trial?
NCT06923150 is sponsored by Qufora A/S. The trial plans to enroll 78 participants.