Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2018

Interventions

  • Other: perineal ultrasound
    • Ultrasound measurement of the size and position of the prostheses.

Arms, Groups and Cohorts

  • Experimental: Perineal ultrasound to visualize the strips and their position

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xaviar FRITEL, Principal Investigator, Poitiers University Hospital

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