Do Prostheses of SphinkeeperTM Migrate After Operation?

Fecal Incontinence Clinical Trial

Official title:

Do Prostheses of SphinkeeperTM Migrate After Operation? - a Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992429
• Other study ID #: 1814/2020
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 18, 2021

Study information

• Verified date: January 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• 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

• Fecal Incontinence

Intervention

Procedure:
• SphinkeeperTM
The SphinkeeperTM includes up to 10 self-expandable prostheses, which get inserted into the intersphincteric place. They are made of inert Hyexpan (polyacrylonitrile)

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	Migration of prostheses	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.	6 months
Secondary	Influence of migration of the prostheses in functionality	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.	6 months
Secondary	Psychological and physical well-being	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)	6 months
Secondary	Morphology of the anal sphincter after operation	Differences of the morphology before and after the operation got examined by endoanal ultrasound.	6 months