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

efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks

LARS difference score between inclusion and 6-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals

Time frame: 6-week follow-up

QoL with the EORTC QLQ-C30 EORTC QLQ-CR29

EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 3-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences between inclusion and 3-month follow-up between interventional arm and control arm

Time frame: 3-month follow- up

change (reduction) of symptoms and consequences

To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6 and 12 weeks The number and the proportion of patients with each item of the LARS international consensus definition at 6 and 12 weeks will be calculated. Also, the proportion of patients who are considered as having no LARS at 6 and 12 weeks will be calculated with a confidence interval

Time frame: 6 weeks and 12 weeks

patient satisfaction

to assess the patient satisfaction at 6 and 12 weeks, The proportion of patients satisfied by the treatment evaluated with the 5-point Likert Scale at 6 and 12 weeks will be calculated with a confidence interval.

Time frame: 6 weeks and 12 weeks

compliance of the patient to the treatmen

to assess the compliance of the patient to the treatment at 6 and 12 weeks Compliance with the treatment during the 6 and 12 weeks of study with the number of days of MiniGo use per week will be calculated using descriptive statistics and confidence intervals

Time frame: 6 weeks and 12 weeks

incontinence anal score

To access the incontinence anal score at 12 weeks Wexner difference score between inclusion and 12-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-week follow-up between interventional arm and control arm.

Time frame: 12 weeks

reduction of defecations per day and night

To assess the reduction of defecations per day and night The mean number of defecations per day and per night during the week before the randomisation and the week before the follow-up visit at 6 and 12 weeks will be calculated.

Time frame: 6 weeks and 12 weeks

time spent on bowel management (in the toilets room)

To assess the time spent on bowel management (in the toilets room) Mean times spent in the toilets room per day the week before the randomisation and the week before the follow-up visit at 12 weeks will be calculated using descriptive statistics.

Time frame: 12 weeks

patient health organization and resources needed

To evaluate the patient health organization and resources needed at 12 weeks Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics.

Time frame: 12 weeks

improving the LARS score

to assess the efficacy on clinical symptom of Transanal Irrigation by MiniGo in improving the LARS score at 6, 9 and 12 months LARS difference score between inclusion and 6, 9 and 12-month follow-ups will be calculated using descriptive statistics and confidence intervals.

Time frame: 6, 9 and 12 months

number of patients showing a change (reduction) of symptoms and consequences

To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6, 9 and 12 months The number and the proportion of patients with each item of the LARS international consensus definition at 6, 9 and 12 months will be calculated. Also, the proportion of patients who are considered as having no LARS at 6, 9 and 12 months will be calculated with a confidence interval.

Time frame: 6, 9 and 12 months

Preference of the patient and reason for it

To assess the preference of the patient and reason for it Proportion of patients who stay on TAI treatment for TAI arm and proportion of patients from SOC arm whose tries and stay on TAI will be calculated using confidence intervals. Description of reasons will be also presented.

Time frame: 12 month follow-up

QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month

to assess the QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 12-month follow-ups will be calculated for each randomised arm using descriptive statistics and confidence intervals.

Time frame: 12-month follow-up

incontinence anal score at 12 months

Wexner difference score between inclusion and 12-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-month follow-up between interventional arm and control arm

Time frame: 12-month follow-up

patient health organization and resources needed at 6, 9 and 12 months

Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics

Time frame: 6, 9 and 12 months