Do Prostheses of SphinkeeperTM Migrate After Operation?

Completed

• Conditions: Fecal Incontinence

• Registration Number: NCT04992429
• Lead Sponsor: Medical University of Vienna

Brief Summary

32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.

Detailed Description

The SphinkeeperTM is a new surgical procedure in order to treat refractory fecal incontinence, which includes up to ten self-expandable prostheses. These get implanted into the intersphincteric space and due to constriction of the anal canal and better contractibility continence should be improved. Because this is a new technique, there is only limited data about its clinical efficacy.

In this study, patients, aged 18-90 years, who met the inclusion criteria and have received a SphinkeeperTM operation, were enrolled. Functional outcomes and quality of life got measured by standard questionnaires before surgery and 1, 2, 3 and 6 months after surgery. Furthermore, in routine check ups patients received endoanal anorectal manometry for pressure measurement and endoanal ultrasound to determine the position of the prostheses.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-01
• Study First Posted: 2021-08-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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
Migration of prostheses	6 months	The migration got analysed by using endoanal ultrasound one, two, three and six months after surgery. The prostheses will be categorized by their position in relation to the anal canal axis.

Secondary Outcome Measures

Name	Time	Method
Morphology of the anal sphincter after operation	6 months	Differences of the morphology before and after the operation got examined by endoanal ultrasound.
Influence of migration of the prostheses in functionality	6 months	Episodes of fecal incontinence and bowel habits were assessed using the Vaizey incontinence score (range 0-22, higher number means severe incontinence). It gets explored if there is a relation between migration of prostheses and worsening of incontinence.
Psychological and physical well-being	6 months	The psychological and physical well-being before and after operation was assessed using the SF-12 standardized questionnaire. (range 0-100; higher scores= Better quality of life)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria