Do Prostheses of SphinkeeperTM Migrate After Operation?

NCT ID: NCT04992429

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-06-18

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.

Conditions

Fecal Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SphinkeeperTM

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christopher Dawoud

Principal Investigator; Dr. med. univ.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Riss, Prof.MD

Role: STUDY_CHAIR

Medical University of Vienna, Head of Pelvic Floor Surgery

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

1814/2020

Identifier Type: -

Identifier Source: org_study_id