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

Last updated: April 3, 2025
Sponsor: Qufora A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT06923150
2023-A02656-39
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 monthsafter the stoma reversal if applicable

  4. LARS score >= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARSdefinition as consensus with at least one symptom that results in at least oneconsequence (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) andabsence of local recurrence by Rectal digital examination of the anastomosis, anyother exam used in the current practice

  8. Patient affiliated to the health social security system

Exclusion

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 significantdisease 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 Design

Total Participants: 78
Study Start date:
June 18, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • CHU Amiens-Picardie

    Amiens, 80054
    France

    Active - Recruiting

  • CHU Besançon

    Besançon, 25030
    France

    Active - Recruiting

  • Clinique Tivoli-Ducos

    Bordeaux, 33000
    France

    Active - Recruiting

  • CHU Grenoble

    La Tronche, 38700
    France

    Active - Recruiting

  • CHU Timone

    Marseille, 13005
    France

    Site Not Available

  • CHU de NANTES, Hôtel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE

    Pessac, 33604
    France

    Site Not Available

  • CH Lyon Sud

    Pierre-benite, 69495
    France

    Site Not Available

  • CHU Charles Nicolle - Rouen

    Rouen, 76 031
    France

    Active - Recruiting

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