SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

NCT04664868 | Completed

• 1 other identifier: 2338/2019
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Faecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychological und physical well-being

  six months

• Migration of Sphinkeeper prostheses

  six months

Interventions

Sphinkeeper™ PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Stefan Riss, Prof.MD

  Medical University of Vienna, Head of Pelvic Floor surgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.univ., Research Fellow

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 11, 2020
• Study Start: August 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)