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Abdominal Versus Vaginal Hysteropexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494582
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hamdy Ahmed Saaid, Ain Shams Maternity Hospital

Study Description
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Brief Summary:
This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

Condition or disease Intervention/treatment Phase
Uterine Prolapse Procedure: Sacral Hysteropexy Procedure: sacrospinous Hysteropexy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : December 1, 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pelvic organ prolapse quantification system [ Time Frame: 3 month ]
    compare Pelvic organ prolapse quantification system between groups


Secondary Outcome Measures :
  1. Perioperative data [ Time Frame: 1 day ]
    operative time

  2. operative details [ Time Frame: 1 day ]
    blood loss


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uterine Prolapse

Exclusion Criteria:

  • Previous prolapse surgery Hereditary Connective tissue disorders
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494582


Locations
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Egypt
Urogynecology Unit
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Hamdy HA Ahmed, MD Ain Shams University
More Information
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Responsible Party: Hamdy Ahmed Saaid, Fellow of OBS/GYN, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03494582    
Other Study ID Numbers: AVVCP
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Prolapse
Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Pelvic Organ Prolapse