Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

NCT ID: NCT03634878

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Prolapse of the Uterus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Perineal ultrasound to visualize the strips and their position

Group Type EXPERIMENTAL

perineal ultrasound

Intervention Type OTHER

Ultrasound measurement of the size and position of the prostheses.

Interventions

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perineal ultrasound

Ultrasound measurement of the size and position of the prostheses.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xaviar FRITEL

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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Chu de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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PROMONTECHO

Identifier Type: -

Identifier Source: org_study_id

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