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

NCT06923150 | Recruiting

• 1 other identifier: 2023-A02656-39
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Gastroenterology; LARS - Low Anterior Resection Syndrome; Rectal Cancer

Keywords

LARS; Transanal Irrigation; Minigo; rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks

  6-week follow-up

• QoL with the EORTC QLQ-C30 EORTC QLQ-CR29

  3-month follow- up

• change (reduction) of symptoms and consequences

  6 weeks and 12 weeks

• patient satisfaction

  6 weeks and 12 weeks

• compliance of the patient to the treatmen

  6 weeks and 12 weeks

Study Arms (2)

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…

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

minor and major LARS patients LARS score \>= 25

You may qualify if:

• 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

You may not qualify if:

• Contra-indication to use TAI
• Former use of TAI (post colo-rectal surgery)
• Clinically relevant stenosis
• Current metastatic disease or local recurrence
• Ongoing chemotherapy
• 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
• 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

Sponsors & Collaborators

• Qufora A/S: lead
• EVAMED: collaborator

Study Sites (9)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

CHU Besançon

Besançon, 25030, France

RECRUITING

Clinique Tivoli-Ducos

Bordeaux, 33000, France

RECRUITING

CHU Grenoble

La Tronche, 38700, France

RECRUITING

CHU Timone

Marseille, 13005, France

NOT YET RECRUITING

CHU de NANTES, Hôtel Dieu

Nantes, 44093, France

RECRUITING

CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE

Pessac, 33604, France

NOT YET RECRUITING

CH Lyon Sud

Pierre-Bénite, 69495, France

NOT YET RECRUITING

CHU Charles Nicolle - Rouen

Rouen, 76 031, France

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Rogini Balachandran

CONTACT

+ 45 42 40 06 20; rob@qufora.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start: June 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

FR (9)