Assessing the effectiveness of low volume transanal irrigation for patients with Low Anterior Resection Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to evaluate the efficacy of low volume transanal irrigation using the Qufora® IrriSedo MiniGo device in patients suffering from Low Anterior Resection Syndrome (LARS) following rectal cancer surgery. The study compares the outcomes of this irrigation method combined with conservative treatment against conservative treatment alone over a period of three months. Eligible participants include adults who have undergone elective surgery for rectal cancer and have experienced LARS symptoms for at least one month. The study will assess clinical symptoms and quality of life improvements in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens-Picardie
  Amiens, France Recruiting
• CHU Besançon
  Besançon, France Recruiting
• Clinique Tivoli-Ducos
  Bordeaux, France Recruiting
• CHU Grenoble
  La Tronche, France Recruiting
• CHU de NANTES, Hôtel Dieu
  Nantes, France Recruiting
• CHU Charles Nicolle - Rouen
  Rouen, France Recruiting

Study contacts

• Study coordinator: Rogini Balachandran
• Email: rob@qufora.com
• Phone: + 45 42 40 06 20

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.