Abdominal Versus Vaginal Hysteropexy

November 30, 2018 updated by: Hamdy Ahmed Saaid, Ain Shams Maternity Hospital

Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse

This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Urogynecology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Uterine Prolapse

Exclusion Criteria:

  • Previous prolapse surgery Hereditary Connective tissue disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sacral Hysteropexy
Abdominal approach for uterine suspension
Procedure: Sacral Hysteropexy
Abdominal approach for uterine suspension
Experimental: sacrospinous Hysteropexy
Transvaginal approach for uterine suspension
Procedure: sacrospinous Hysteropexy
Transvaginal approach for uterine suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic organ prolapse quantification system
Time Frame: 3 month
compare Pelvic organ prolapse quantification system between groups
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative data
Time Frame: 1 day
operative time
1 day
operative details
Time Frame: 1 day
blood loss
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Hamdy HA Ahmed, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVVCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Prolapse

Clinical Trials on Sacral Hysteropexy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe