NCT06923150Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 78 (estimated)
- First submitted
- 3 Apr 2025
- Start date
- 18 Jun 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Qufora A/S
- Diseases
- Colorectal cancer
- NCT number
- NCT06923150
What you commit to
- Study type: Observational
- Planned participants: 78
- From 18 Jun 2024 to the primary completion date, Dec 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Former use of TAI (post colo-rectal surgery)
- Ongoing chemotherapy
Other illness
- Current metastatic disease or local recurrence
- 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
Other
- Contra-indication to use TAI
- Clinically relevant stenosis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Grenoble Coordinator of this site? Confirm its status | La Tronche | France | Recruiting |
| Chu Timone Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| CH Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Not yet recruiting |
| CHU Charles Nicolle - Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.