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Abdominal Versus Vaginal Hysteropexy

Primary Purpose

Uterine Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sacral Hysteropexy
sacrospinous Hysteropexy
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Prolapse

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Uterine Prolapse

Exclusion Criteria:

  • Previous prolapse surgery Hereditary Connective tissue disorders

Sites / Locations

  • Urogynecology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sacral Hysteropexy

sacrospinous Hysteropexy

Arm Description

Abdominal approach for uterine suspension

Transvaginal approach for uterine suspension

Outcomes

Primary Outcome Measures

Pelvic organ prolapse quantification system
compare Pelvic organ prolapse quantification system between groups

Secondary Outcome Measures

Perioperative data
operative time
operative details
blood loss

Full Information

First Posted
March 29, 2018
Last Updated
November 30, 2018
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03494582
Brief Title
Abdominal Versus Vaginal Hysteropexy
Official Title
Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity 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
This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse
Detailed Description
this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sacral Hysteropexy
Arm Type
Experimental
Arm Description
Abdominal approach for uterine suspension
Arm Title
sacrospinous Hysteropexy
Arm Type
Experimental
Arm Description
Transvaginal approach for uterine suspension
Intervention Type
Procedure
Intervention Name(s)
Sacral Hysteropexy
Intervention Description
Abdominal approach for uterine suspension
Intervention Type
Procedure
Intervention Name(s)
sacrospinous Hysteropexy
Intervention Description
Transvaginal approach for uterine suspension
Primary Outcome Measure Information:
Title
Pelvic organ prolapse quantification system
Description
compare Pelvic organ prolapse quantification system between groups
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Perioperative data
Description
operative time
Time Frame
1 day
Title
operative details
Description
blood loss
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Uterine Prolapse Exclusion Criteria: Previous prolapse surgery Hereditary Connective tissue disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamdy HA Ahmed, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urogynecology Unit
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Abdominal Versus Vaginal Hysteropexy

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