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Completed

NCT Number: NCT05196542

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

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

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shibīn al Kawm, Menoufia, 32951, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. operative time

    Time frame: 60 minutes

    time taken from start of operation till its end

  2. blood loss

    Time frame: during surgery time

    amount in CC

  3. occurrence of major complications as vascular injury or ureteric injury

    Time frame: during surgery

    injury

  4. urinary retention

    Time frame: 24 hours

    inability to pass urine after catheter removal

  5. hospital stay duration

    Time frame: 24 hours

    how many hours patient stay in hospital after procedure till discharge

Secondary outcomes

  1. occurrence of relapse

    Time frame: 1year after procedure

    recurrence of prolapse

  2. erosion

    Time frame: 1 year after procedure

    exposure of mesh or tape used

Sponsors and collaborators

Lead sponsor

Mohamed Elsibai Anter

Other

Registry information

Official study title

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

Acronym: hystropexy

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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