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NCT06923150Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
78 (estimated)
First submitted
3 Apr 2025
Start date
18 Jun 2024
Primary completion date
Dec 2026
Lead sponsor
Qufora A/S
NCT number
NCT06923150

What you commit to

  • Study type: Observational
  • Planned participants: 78
  • From 18 Jun 2024 to the primary completion date, Dec 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Former use of TAI (post colo-rectal surgery)
  • Ongoing chemotherapy

Other illness

  • Current metastatic disease or local recurrence
  • 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

Other

  • Contra-indication to use TAI
  • Clinically relevant stenosis
  • 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
  • Inability and unwillingness to give informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Amiens Picardie
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AmiensFranceRecruiting
CHU Besançon
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BesançonFranceRecruiting
Clinique Tivoli-Ducos
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BordeauxFranceRecruiting
CHU Grenoble
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La TroncheFranceRecruiting
Chu Timone
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MarseilleFranceNot yet recruiting
CHU de Nantes - Hôtel Dieu
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NantesFranceRecruiting
CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
Coordinator of this site? Confirm its status
PessacFranceNot yet recruiting
CH Lyon Sud
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Pierre-BéniteFranceNot yet recruiting
CHU Charles Nicolle - Rouen
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RouenFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.