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.
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)
Contra-indication to use TAI
Former use of TAI (post colo-rectal surgery)
Clinically relevant stenosis
Current metastatic disease or local recurrence
minor and major LARS patients LARS score \>= 25
Other
Prospective
Not listed
LARS score difference
The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.
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
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
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
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.
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Qufora A/S
Lead sponsor
EVAMED
Collaborator
