SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Faecal Incontinence Clinical Trial

Official title:

SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664868
• Other study ID #: 2338/2019
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 1, 2020
• Est. primary completion date: November 1, 2019
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	six months
Secondary	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)	six months
Secondary	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)	six months