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

ConditionsGastroenterology LARS - Low Anterior Resection Syndrome Rectal Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorQufora A/S

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Contra-indication to use TAI

Former use of TAI (post colo-rectal surgery)

Clinically relevant stenosis

Current metastatic disease or local recurrence

Trial design

Treatments tested in this trial

Not listed

Trial groups

78 Participants

are grouped into 2 trial groups

Sponsors and collaborators

Qufora A/S

Lead sponsor

EVAMED

Collaborator

Source ClinicalTrials.gov