Back to resultsEvaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound (PROMONOTECHO)
Primary Purpose
Prolapse of the Uterus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
perineal ultrasound
Sponsored by
About this trial
This is an interventional other trial for Prolapse of the Uterus
Eligibility Criteria
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.
Sites / Locations
- Chu de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perineal ultrasound to visualize the strips and their position
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
Secondary Outcome Measures
Collect the position of the strips
Collect the symptoms of the patients
Full Information
NCT ID
NCT03634878
First Posted
August 6, 2018
Last Updated
April 10, 2020
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03634878
Brief Title
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
Acronym
PROMONOTECHO
Official Title
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse of the Uterus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineal ultrasound to visualize the strips and their position
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
perineal ultrasound
Intervention Description
Ultrasound measurement of the size and position of the prostheses.
Primary Outcome Measure Information:
Title
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
Time Frame
10 minutes
Title
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Collect the position of the strips
Time Frame
20 minutes
Title
Collect the symptoms of the patients
Time Frame
20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xaviar FRITEL
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
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