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Clinical Trials/NCT03634878
NCT03634878
Completed
Not Applicable

Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Poitiers University Hospital1 site in 1 country50 target enrollmentStarted: April 2016Last updated:
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ConditionsProlapse of the Uterus

Overview

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Collect the position of the strips(20 minutes)
  • Collect the symptoms of the patients(20 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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