Do Prostheses of SphinkeeperTM Migrate After Operation?

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT04992429
Collaborator
(none)
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Study Details

Study Description

Brief Summary

10 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: SphinkeeperTM

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 Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Do Prostheses of SphinkeeperTM Migrate After Operation? - a Prospective Pilot Study
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jun 18, 2021
Actual Study Completion Date :
Jun 18, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

  3. Morphology of the anal sphincter after operation [6 months]

    Differences of the morphology before and after the operation got examined by endoanal ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Study Chair: Stefan Riss, Prof.MD, Medical University of Vienna, Head of Pelvic Floor Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Christopher Dawoud, Principal Investigator; Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04992429
Other Study ID Numbers:
  • 1814/2020
First Posted:
Aug 5, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021