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)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 78

Contacts and Locations

• Study Contact: Name: Rogini Balachandran; Phone Number: + 45 42 40 06 20; Email: rob@qufora.com

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: Charles SABBAGH
  • Besançon, France, 25030
    • Recruiting
    • CHU Besançon
    • Contact: Zaher LAKKIS
  • Bordeaux, France, 33000
    • Recruiting
    • Clinique Tivoli-Ducos
    • Contact: Quentin DENOST
  • La Tronche, France, 38700
    • Recruiting
    • CHU Grenoble
    • Contact: Jean-Luc FAUCHERON
  • Marseille, France, 13005
    • Not yet recruiting
    • CHU Timone
    • Contact: Diane MEGE
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes, Hôtel Dieu
    • Contact: Emilie DUCHALAIS DASSONNEVILLE
  • Pessac, France, 33604
    • Not yet recruiting
    • CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
    • Contact: Benjamin FERNANDEZ
  • Pierre-benite, France, 69495
    • Not yet recruiting
    • CH Lyon Sud
    • Contact: Eddy COTTE
  • Rouen, France, 76 031
    • Recruiting
    • CHU Charles Nicolle - Rouen
    • Contact: Valérie BRIDOUX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

minor and major LARS patients LARS score >= 25

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
TAI + SOC; Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments
SOC; 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…

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS score difference	The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.	3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks	LARS difference score between inclusion and 6-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals	6-week follow-up
QoL with the EORTC QLQ-C30 EORTC QLQ-CR29	EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 3-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences between inclusion and 3-month follow-up between interventional arm and control arm	3-month follow- up
change (reduction) of symptoms and consequences	To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6 and 12 weeks The number and the proportion of patients with each item of the LARS international consensus definition at 6 and 12 weeks will be calculated. Also, the proportion of patients who are considered as having no LARS at 6 and 12 weeks will be calculated with a confidence interval	6 weeks and 12 weeks
patient satisfaction	to assess the patient satisfaction at 6 and 12 weeks, The proportion of patients satisfied by the treatment evaluated with the 5-point Likert Scale at 6 and 12 weeks will be calculated with a confidence interval.	6 weeks and 12 weeks
compliance of the patient to the treatmen	to assess the compliance of the patient to the treatment at 6 and 12 weeks Compliance with the treatment during the 6 and 12 weeks of study with the number of days of MiniGo use per week will be calculated using descriptive statistics and confidence intervals	6 weeks and 12 weeks
incontinence anal score	To access the incontinence anal score at 12 weeks Wexner difference score between inclusion and 12-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-week follow-up between interventional arm and control arm.	12 weeks
reduction of defecations per day and night	To assess the reduction of defecations per day and night The mean number of defecations per day and per night during the week before the randomisation and the week before the follow-up visit at 6 and 12 weeks will be calculated.	6 weeks and 12 weeks
time spent on bowel management (in the toilets room)	To assess the time spent on bowel management (in the toilets room) Mean times spent in the toilets room per day the week before the randomisation and the week before the follow-up visit at 12 weeks will be calculated using descriptive statistics.	12 weeks
patient health organization and resources needed	To evaluate the patient health organization and resources needed at 12 weeks Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics.	12 weeks
improving the LARS score	to assess the efficacy on clinical symptom of Transanal Irrigation by MiniGo in improving the LARS score at 6, 9 and 12 months LARS difference score between inclusion and 6, 9 and 12-month follow-ups will be calculated using descriptive statistics and confidence intervals.	6, 9 and 12 months
number of patients showing a change (reduction) of symptoms and consequences	To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6, 9 and 12 months The number and the proportion of patients with each item of the LARS international consensus definition at 6, 9 and 12 months will be calculated. Also, the proportion of patients who are considered as having no LARS at 6, 9 and 12 months will be calculated with a confidence interval.	6, 9 and 12 months
Preference of the patient and reason for it	To assess the preference of the patient and reason for it Proportion of patients who stay on TAI treatment for TAI arm and proportion of patients from SOC arm whose tries and stay on TAI will be calculated using confidence intervals. Description of reasons will be also presented.	12 month follow-up
QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month	to assess the QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 12-month follow-ups will be calculated for each randomised arm using descriptive statistics and confidence intervals.	12-month follow-up
incontinence anal score at 12 months	Wexner difference score between inclusion and 12-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-month follow-up between interventional arm and control arm	12-month follow-up
patient health organization and resources needed at 6, 9 and 12 months	Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics	6, 9 and 12 months

Collaborators and Investigators

• Sponsor: Qufora A/S
• Collaborators: EVAMED

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: rectal cancer; LARS; Transanal Irrigation; Minigo
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Low Anterior Resection Syndrome; Syndrome; Rectal Neoplasms
• Other Study ID Numbers: 2023-A02656-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No