SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Status Completed

Clinical Trial Summary

Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

Clinical Trial Description

The Sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper™ surgery in patients with refractory FI. Patients with FI, who met the inclusion criteria were enrolled to our study and received Sphinkeeper™ implantation. Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery. In the routine check-up patients received endoanal ultrasound and anorectal manometry. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04664868
Study type	Observational
Source	Medical University of Vienna
Contact
Status	Completed
Phase
Start date	August 1, 2018
Completion date	July 1, 2020

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