SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Medical University of Vienna11 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Faecal Incontinence

Interventions

Sphinkeeper™PROCEDURE

Sphinkeeper™ prostheses are self-expandable solid prostheses, made of inert Hyexpan (polyacrylonitrile) and are inserted into the intersphincteric anal groove.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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. 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

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Faecal incontinence assessment

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)

Time frame: six months

Secondary Outcomes

Psychological und physical well-being

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)

Time frame: six months

Migration of Sphinkeeper prostheses

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)

Time frame: six months

Data from ClinicalTrials.gov

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