Assessing the effectiveness of low volume transanal irrigation for patients with Low Anterior Resection Syndrome
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
This study is testing if a new low-volume irrigation method can help adults with Low Anterior Resection Syndrome feel better after rectal cancer surgery compared to standard treatment alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qufora A/S Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Amiens and 8 other locations) |
| Trial ID | NCT06923150 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the efficacy of low volume transanal irrigation using the Qufora® IrriSedo MiniGo device in patients suffering from Low Anterior Resection Syndrome (LARS) following rectal cancer surgery. The study compares the outcomes of this irrigation method combined with conservative treatment against conservative treatment alone over a period of three months. Eligible participants include adults who have undergone elective surgery for rectal cancer and have experienced LARS symptoms for at least one month. The study will assess clinical symptoms and quality of life improvements in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone low anterior resection for rectal cancer and have a LARS score of 25 or higher.
Not a fit: Patients who have contraindications to transanal irrigation or have previously used this method after colorectal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of LARS symptoms and enhance the quality of life for affected patients.
How similar studies have performed: While this approach is relatively novel, similar studies assessing transanal irrigation for LARS have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens and 8 other locations
- CHU Amiens-Picardie — Amiens, France (Recruiting)
- CHU Besançon — Besançon, France (Recruiting)
- Clinique Tivoli-Ducos — Bordeaux, France (Recruiting)
- CHU Grenoble — La Tronche, France (Recruiting)
- CHU Timone — Marseille, France (Not_yet_recruiting)
- CHU de NANTES, Hôtel Dieu — Nantes, France (Recruiting)
- CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE — Pessac, France (Not_yet_recruiting)
- CH Lyon Sud — Pierre-Bénite, France (Not_yet_recruiting)
- CHU Charles Nicolle - Rouen — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Rogini Balachandran
- Email: rob@qufora.com
- Phone: + 45 42 40 06 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.