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Apical ProlapsehystropexyNCT05196542

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

A study testing patients with apical prolapse who will do Sacro hysteropexy using mersilene tape in people with Apical Prolapse, run by Mohamed Elsibai Anter at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Apical Prolapse
What is being tested?
patients with apical prolapse who will do Sacro hysteropexy using mersilene tape
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Nov 2019to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Menoufia University

    Shibīn al Kawm, Menoufia, 32951

Other trials in Egypt

About this study

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

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

Read the 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.

Conditions
Apical Prolapse
Being tested
patients with apical prolapse who will do Sacro hysteropexy using mersilene tape
Keywords
hystropexy, mesh, mersilene tape

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT05196542
Study groupRoleWhat they receive
mersilene tape arm (ETHICON, polyester 5mm double needle)ExperimentalGroup 1: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape (polyester 5mm tape with double needle)
Receives: Procedure: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape
polyproline mesh arm (ETHICON, polyprolene mesh)OtherGroup 2: patients with apical prolapse who will do Sacro hysteropexy using poly-proline mesh
Receives: Procedure: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operative time

    time taken from start of operation till its end

    Measured: 60 minutes

  2. blood loss

    amount in CC

    Measured: during surgery time

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

    injury

    Measured: during surgery

  4. urinary retention

    inability to pass urine after catheter removal

    Measured: 24 hours

  5. hospital stay duration

    how many hours patient stay in hospital after procedure till discharge

    Measured: 24 hours

Secondary outcomes (2)
  1. occurrence of relapse

    recurrence of prolapse

    Measured: 1year after procedure

  2. erosion

    exposure of mesh or tape used

    Measured: 1 year after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start1 Nov 2019
  3. Primary completion1 Nov 2020
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05196542
Sponsor's protocol ID
Simple Mail Transfer Protocol
Acronym
hystropexy
Status last verified
Jan 2022
First submitted
26 Nov 2021
Last updated
19 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing patients with apical prolapse who will do Sacro hysteropexy using mersilene tape in people with Apical Prolapse, run by Mohamed Elsibai Anter at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operative time (time frame: 60 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.

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