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 (MINIGO)

Qufora

Status: Enrolling

Conditions: LARS - Low Anterior Resection Syndrome; Gastroenterology; Rectal Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06923150

2023-A02656-39

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

78 participants in 2 patient groups

TAI + SOC

Description:

Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments

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...