SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Completed

• Conditions: Faecal Incontinence

• Registration Number: NCT04664868
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed 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 Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-07-01
• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
• Ability and willingness to understand and comply with study interventions and restrictions.
• Voluntarily signed informed consent after full explanation of the study to the participant.

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Exclusion Criteria

• Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
• Inability to communicate well with the investigator due to language problems or reduced mental development
• Inability or unwillingness to give written informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Faecal incontinence assessment	six months	Episodes and number of faecal incomtinence and stool form with faecal incontinence were assessed using the Vaizey incontinence score (range 0-22, higher numbers mean severe incontinence forms)

Secondary Outcome Measures

Name	Time	Method
Migration of Sphinkeeper prostheses	six months	The Migration of Sphinkeeper prostheses were analyzed using endoanal ultrasound one and six months after implantation. The prostheses will be categorized by their position in relation to the anal canal axis. (Grade of rotation to the anal canal axis)
Psychological und physical well-being	six months	The Psychological und physical well-being before and after implantation of Sphinkeeper was assessed using the SF12 standardized questionnaire (range 0-100; higher scores= Better quality of life)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria