Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound (PROMONOTECHO)

April 10, 2020 updated by: Poitiers University Hospital

Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.

These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86021
        • CHU de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age ≥ 18 years of female sex
  • Patient with double laparoscopic promontofixation without associated hysterectomy

Exclusion Criteria:

  • History of hysterectomy
  • Anterior cure (before index intervention) of prolapse with placement of prosthetic material.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perineal ultrasound to visualize the strips and their position
Other: perineal ultrasound
Ultrasound measurement of the size and position of the prostheses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
Time Frame: 10 minutes
10 minutes
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
Time Frame: 20 minutes
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Collect the position of the strips
Time Frame: 20 minutes
20 minutes
Collect the symptoms of the patients
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Xaviar FRITEL, Poitiers university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMONTECHO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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