Skip to main content
OpenTrials
Completed

NCT Number: NCT04992429

Do Prostheses of SphinkeeperTM Migrate After Operation?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SphinkeeperTM

Procedure

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

Primary outcomes

  1. Migration of prostheses

    Time frame: 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 outcomes

  1. Influence of migration of the prostheses in functionality

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.