SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

December 7, 2020 updated by: Dr. Christopher Dawoud, Medical University of Vienna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Candidates for sphinkeeper operations due to fecal incontinence will be enrolled in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faecal incontinence assessment
Time Frame: 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)
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological und physical well-being
Time Frame: 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)
six months
Migration of Sphinkeeper prostheses
Time Frame: 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)
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Chair: Stefan Riss, Prof.MD, Medical University of Vienna, Head of Pelvic Floor Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2338/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD can be shared just in anonymised form in case of an ethical agreement with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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