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

Launched by QUFORA A/S · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people who have Low Anterior Resection Syndrome (LARS), a condition that can occur after surgery for rectal cancer. The trial compares a device called the Qufora® IrriSedo MiniGo, which helps with bowel management through a method called Transanal Irrigation, to standard conservative treatment. The goal is to see if using the MiniGo can improve symptoms of LARS within three months.

To participate, individuals must be at least 18 years old and have undergone surgery for rectal cancer, experiencing LARS symptoms for 3 to 18 months after their surgery. They should also have already tried other conservative treatments for at least a month. Participants will learn how to use the MiniGo and will be monitored for improvements in their symptoms. It's important to note that some people may not be eligible to join the trial, including those with certain medical conditions or treatments that could affect participation. This study is currently looking for volunteers, and those who join will play a key role in helping to evaluate this potential new treatment.

Gender

ALL

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