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

NCT05196542 | Completed

• 1 other identifier: Simple Mail Transfer Protocol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse: a Randomized Controlled Study .Aim of This Study is to Compare Between Using Poly-proline Mesh Versus Mersilene Tape in Abdominal Sacrohysteropexy Repairing Apical Prolapse Stage 2 or More. Outcome Measures: Short Term: investigators Will Evaluate Operative Time, Blood Loss, Hospital Stay Duration, Occurrence of Major Complications, Episodes of Constipation, Urinary Retention and Urinary Tract Infection. Long Term (After 1 year): investigators Will Evaluate Occurrence of Relapse as Well as Late Complications. Local Symptoms, Quality of Life and Sexual Function Will be Evaluated by a Questioner Before and After Surgery

Conditions

Apical Prolapse

Keywords

hystropexy; mesh; mersilene 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 tape PROCEDURE

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)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (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
• Patient has no uterine pathology necessitate hysterectomy and patient wish to retain her uterus.

You may not qualify if:

• Unfitness for anesthesia
• Present pelvic inflammatory disease
• Previously identified or suspected massive adhesions between sigmoid and pre-sacral peritoneum.
• Previous pelvic operations or trial of sling operation

Sponsors & Collaborators

• Mohamed Elsibai Anter: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32951, Egypt

Location

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
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)