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CompletedNCT03494582Updated Dec 3, 2018

Abdominal Versus Vaginal Hysteropexy

An interventional study of Sacral Hysteropexy and sacrospinous Hysteropexy in Uterine Prolapse, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-12-03.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Uterine Prolapse
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Uterine Prolapse

Exclusion criteria

Exclusion Criteria:

  • Previous prolapse surgery Hereditary Connective tissue disorders
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Sacral Hysteropexy

    Abdominal approach for uterine suspension

    Procedure: Sacral Hysteropexy

  • Experimental
    sacrospinous Hysteropexy

    Transvaginal approach for uterine suspension

    Procedure: sacrospinous Hysteropexy

Interventions

  • ProcedureSacral Hysteropexy

    Abdominal approach for uterine suspension

  • Proceduresacrospinous Hysteropexy

    Transvaginal approach for uterine suspension

05

What researchers measure

Primary outcomes

  1. Pelvic organ prolapse quantification system

    compare Pelvic organ prolapse quantification system between groups

    Time frame: 3 month

Secondary outcomes

  1. Perioperative data

    operative time

    Time frame: 1 day

  2. operative details

    blood loss

    Time frame: 1 day

06

Study locations

1 site
  • Urogynecology Unit
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03494582
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Hamdy Ahmed Saaid (Fellow of OBS/GYN, Ain Shams Maternity Hospital) — Principal investigator
First posted
Apr 11, 2018
Start date
Apr 1, 2017
Primary completion
Oct 1, 2018
Completion
Dec 1, 2018
Last update
Dec 3, 2018

Study contacts

Hamdy HA Ahmed, MD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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