Clinical trial · Observational
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
NCT06923150CI-TRIAL-00088480MINIGOrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenterology | — | UNRESOLVED | — |
| LARS - Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- TAI + SOC
- description
- Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments
- label
- SOC
- description
- Standard of Care (SOC) conservative treatments: dietary management, counselling, medication: anti-diarrheic or constipation treatment according to the prescription following usual practice, and food supplement excluding: suppository, ano-rectal stimulation, physiotherapy small enemas, etc…
Primary outcomes (1)
- measure
- LARS score difference
- timeFrame
- 3-month follow-up
- description
- The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.
Secondary outcomes (15)
- measure
- efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.