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Recruiting NCT06923150

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

— Observational Gastroenterology LARS - Low Anterior Resection Syndrome Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastroenterology, LARS - Low Anterior Resection Syndrome, Rectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • LARS score difference [Time frame: 3-month follow-up]
Secondary outcome measures (12)
  • efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks [Time frame: 6-week follow-up]
  • QoL with the EORTC QLQ-C30 EORTC QLQ-CR29 [Time frame: 3-month follow- up]
  • change (reduction) of symptoms and consequences [Time frame: 6 weeks and 12 weeks]
  • patient satisfaction [Time frame: 6 weeks and 12 weeks]
  • compliance of the patient to the treatmen [Time frame: 6 weeks and 12 weeks]
  • incontinence anal score [Time frame: 12 weeks]
  • reduction of defecations per day and night [Time frame: 6 weeks and 12 weeks]
  • time spent on bowel management (in the toilets room) [Time frame: 12 weeks]
  • patient health organization and resources needed [Time frame: 12 weeks]
  • improving the LARS score [Time frame: 6, 9 and 12 months]
  • number of patients showing a change (reduction) of symptoms and consequences [Time frame: 6, 9 and 12 months]
  • Preference of the patient and reason for it [Time frame: 12 month follow-up]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Inability and unwillingness to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 9 centers
  • CHU Amiens-Picardie — Amiens
  • CHU Besançon — Besançon
  • Clinique Tivoli-Ducos — Bordeaux
  • CHU Grenoble — La Tronche
  • CHU Timone — Marseille
  • CHU de NANTES, Hôtel Dieu — Nantes
  • CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE — Pessac
  • CH Lyon Sud — Pierre-Bénite
  • … and 1 more center

Identifiers

NCT: NCT06923150 · 2023-A02656-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗