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

Apical Prolapse Clinical Trial

— hystropexy  

Official title:

Abdominal Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05196542
• Other study ID #: Simple Mail Transfer Protocol
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apical Prolapse
• Prolapse

Intervention

Procedure:
• patients with apical prolapse who will do Sacro hysteropexy using mersilene tape
comparison between standard poly prolene mesh and the poly ester mersilene tape in Sacro hysteropexy surgical procedure

Locations

Country	Name	City	State
Egypt	Menoufia University	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Elsibai Anter

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	time taken from start of operation till its end	60 minutes
Primary	blood loss	amount in CC	during surgery time
Primary	occurrence of major complications as vascular injury or ureteric injury	injury	during surgery
Primary	urinary retention	inability to pass urine after catheter removal	24 hours
Primary	hospital stay duration	how many hours patient stay in hospital after procedure till discharge	24 hours
Secondary	occurrence of relapse	recurrence of prolapse	1year after procedure
Secondary	erosion	exposure of mesh or tape used	1 year after procedure