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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroenterology LARS - Low Anterior Resection Syndrome Rectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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TAI + SOC

Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments

No interventions assigned to this group

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…

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No