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OpenTrials
Completed

NCT Number: NCT03634878

Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

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

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Key information

Conditions

Prolapse of the Uterus

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

perineal ultrasound

Other

Ultrasound measurement of the size and position of the prostheses.

Primary outcomes

  1. Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses

    Time frame: 10 minutes

  2. Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses

    Time frame: 20 minutes

Secondary outcomes

  1. Collect the position of the strips

    Time frame: 20 minutes

  2. Collect the symptoms of the patients

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: PROMONOTECHO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2018
Registry last updated
Apr 13, 2020

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.