Abdominal Versus Vaginal Hysteropexy | NCT03494582

Studies
Abdominal Versus Vaginal Hysteropexy

NCT03494582

Sponsor

Ain Shams Maternity Hospital

Status

Completed

Last Update Posted

Dec 3, 2018Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Uterine Prolapse

Interventions

Sacral Hysteropexy
sacrospinous Hysteropexy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Mar 29, 2018

First Submission Date that Met QC Criteria

Apr 4, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2018

Last Update Posted Date

Dec 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacral Hysteropexy	Experimental	Abdominal approach for uterine suspension	Procedure: Sacral Hysteropexy
sacrospinous Hysteropexy	Experimental	Transvaginal approach for uterine suspension	Procedure: sacrospinous Hysteropexy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sacral Hysteropexy	Procedure	Abdominal approach for uterine suspension	Sacral Hysteropexy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uterine Prolapse

Exclusion Criteria:

Previous prolapse surgery Hereditary Connective tissue disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamdy HA Ahmed, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urogynecology Unit		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014596	Uterine Prolapse

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided