Trials Sponsors Conditions Drugs Pricing

Conditions

Apical Prolapse

Keywords

hystropexymeshmersilene tape

Outcome Measures

Primary Outcomes (5)

operative time
time taken from start of operation till its end
60 minutes
blood loss
amount in CC
during surgery time
occurrence of major complications as vascular injury or ureteric injury
injury
during surgery
urinary retention
inability to pass urine after catheter removal
24 hours
hospital stay duration
how many hours patient stay in hospital after procedure till discharge
24 hours

Secondary Outcomes (2)

occurrence of relapse
1year after procedure
erosion
1 year after procedure

Study Arms (2)

mersilene tape arm (ETHICON, polyester 5mm double needle)

EXPERIMENTAL

Group 1: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape (polyester 5mm tape with double needle)

Procedure: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape

polyproline mesh arm (ETHICON, polyprolene mesh)

OTHER

Group 2: patients with apical prolapse who will do Sacro hysteropexy using poly-proline mesh

Procedure: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape

Interventions

patients with apical prolapse who will do Sacro hysteropexy using mersilene tapeProcedure

comparison between standard poly prolene mesh and the poly ester mersilene tape in Sacro hysteropexy surgical procedure

mersilene tape arm (ETHICON, polyester 5mm double needle)polyproline mesh arm (ETHICON, polyprolene mesh)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Women planning sacrohysteropexy for stage 2, 3, or 4 prolapse with or without stress urinary incontinence.
Age between 25 and 45

Sponsors & Collaborators

Mohamed Elsibai Anter
Otherlead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32951, Egypt

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: participants will be aware of procedure but unaware of the material used for repair
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: principal investigator

Study Record Dates

First Submitted

November 26, 2021

First Posted

January 19, 2022

Study Start

November 1, 2019

Actual (reported)

Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (2)

Study Arms (2)

mersilene tape arm (ETHICON, polyester 5mm double needle)

polyproline mesh arm (ETHICON, polyprolene mesh)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (2)

Study Arms (2)

mersilene tape arm (ETHICON, polyester 5mm double needle)

polyproline mesh arm (ETHICON, polyprolene mesh)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations