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

Primary Purpose

Apical Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
patients with apical prolapse who will do Sacro hysteropexy using mersilene tape
Sponsored by
Mohamed Elsibai Anter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Apical Prolapse focused on measuring hystropexy, mesh, mersilene tape

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Menoufia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

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

polyproline mesh arm (ETHICON, polyprolene mesh)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

occurrence of relapse
recurrence of prolapse
erosion
exposure of mesh or tape used

Full Information

First Posted
November 26, 2021
Last Updated
January 17, 2022
Sponsor
Mohamed Elsibai Anter
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1. Study Identification

Unique Protocol Identification Number
NCT05196542
Brief Title
Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse
Acronym
hystropexy
Official Title
Abdominal Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Elsibai Anter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Aim of this study is to compare between using poly-proline mesh versus mersilene tape in abdominal sacrohysteropexy repairing apical prolapse stage ӀӀ or more. Study Design: This will be a prospective randomized controlled non blind study will include cases with apical prolapse stage 2 or more undergoing abdominal sling between October 2019 and September 2020 in Obstetrics and Gynecology Department, Ain Shams University Hospital and menofia university hospital. Inclusion Criteria: 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. Exclusion Criteria: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. Prolapse is staged with the use of the pelvic-organ-prolapse quantification (POP-Q) system, a standardized quantitative method for assessment of prolapse. PISQ-12 assesses the sexual function of the woman with prolapse. Urinary incontinence is ruled out by history, examination and urodynamic study. Randomization using a list of computer-generated random sample into two groups. Group1:patients with apical prolapse who will do Sacro hysteropexy using poly-proline mesh, Group 2:patients with apical prolapse who will do Sacro hysteropexy using mersilene tape. Technique of procedure: Participants will receive bowel preparation the day before surgery, Prophylactic antibiotics will be given preoperatively. Abdominal Sacro colpopexy will be performed by laparotomy under general or spinal anesthesia, preferably using a pfannenstiel incision. In group (1) using poly-proline mesh to be fixed to the cervix at the level of the internal os at the uterosacral ligament and the other end to the longitudinal vertebral ligament by non-absorbable sutures. Excess mesh is trimmed and removed. In group (2) using mersilene tape with double needle to anchor the cervix at the level of the internal os by stitches and then fixed to the longitudinal vertebral ligament. Mesh or tape should be completely covered by peritoneum. If the patient complains of stress urinary incontinence, it will be managed by trans-obturator tape (TOT) and procedure will be recorded. 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 1year), investigators will evaluate occurrence of relapse as well as late complications. Also local symptoms, quality of life and sexual function will be evaluated by a questioner before and after surgery. Sample size: Study will include cases with apical prolapse stage ӀӀ or more undergoing abdominal sling between October 2019 and September 2020 in Obstetrics and Gynecology Department, Ain Shams University Hospital and menofia university hospital. On prevalence of 7% and power of 80, number of cases will be estimated of 50 cases in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Prolapse
Keywords
hystropexy, mesh, mersilene tape

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
participants will be aware of procedure but unaware of the material used for repair
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mersilene tape arm (ETHICON, polyester 5mm double needle)
Arm Type
Experimental
Arm Description
Group 1: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape (polyester 5mm tape with double needle)
Arm Title
polyproline mesh arm (ETHICON, polyprolene mesh)
Arm Type
Other
Arm Description
Group 2: patients with apical prolapse who will do Sacro hysteropexy using poly-proline mesh
Intervention Type
Procedure
Intervention Name(s)
patients with apical prolapse who will do Sacro hysteropexy using mersilene tape
Intervention Description
comparison between standard poly prolene mesh and the poly ester mersilene tape in Sacro hysteropexy surgical procedure
Primary Outcome Measure Information:
Title
operative time
Description
time taken from start of operation till its end
Time Frame
60 minutes
Title
blood loss
Description
amount in CC
Time Frame
during surgery time
Title
occurrence of major complications as vascular injury or ureteric injury
Description
injury
Time Frame
during surgery
Title
urinary retention
Description
inability to pass urine after catheter removal
Time Frame
24 hours
Title
hospital stay duration
Description
how many hours patient stay in hospital after procedure till discharge
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
occurrence of relapse
Description
recurrence of prolapse
Time Frame
1year after procedure
Title
erosion
Description
exposure of mesh or tape used
Time Frame
1 year after procedure

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Menoufia University
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32951
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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