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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 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.
operative time
time taken from start of operation till its end
Measured: 60 minutes
blood loss
amount in CC
Measured: during surgery time
occurrence of major complications as vascular injury or ureteric injury
injury
Measured: during surgery
urinary retention
inability to pass urine after catheter removal
Measured: 24 hours
hospital stay duration
how many hours patient stay in hospital after procedure till discharge
Measured: 24 hours
Secondary outcomes (2)
occurrence of relapse
recurrence of prolapse
Measured: 1year after procedure
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.
- First posted19 Jan 2022
- Study start1 Nov 2019
- Primary completion1 Nov 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mohamed Elsibai Anter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Elsibai Anter, Menoufia University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Sacro-hysteropexy Using Proline Mesh Versus Mersilene Tape in Apical Prolapse: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05196542
- Acronym / sponsor ID
- hystropexy / Simple Mail Transfer Protocol
- Conditions
- Apical Prolapse
- Keywords
- hystropexy, mesh, mersilene tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mohamed Elsibai AnterUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mersilene tape arm (ETHICON, polyester 5mm double needle) | Experimental | Procedure: patients with apical prolapse who will do Sacro hysteropexy using mersilene tapeGroup 1: patients with apical prolapse who will do Sacro hysteropexy using mersilene tape (polyester 5mm tape with double needle) |
| polyproline mesh arm (ETHICON, polyprolene mesh) | Other | Procedure: patients with apical prolapse who will do Sacro hysteropexy using mersilene tapeGroup 2: patients with apical prolapse who will do Sacro hysteropexy using poly-proline mesh |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women planning sacrohysteropexy for stage 2, 3, or 4 prolapse with or without stress urinary incontinence.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients with apical prolapse who will do Sacro hysteropexy using mersilene tapecomparison between standard poly prolene mesh and the poly ester mersilene tape in Sacro hysteropexy surgical procedure | Procedure or surgery | mersilene tape arm (ETHICON, polyester 5mm double needle), polyproline mesh arm (ETHICON, polyprolene mesh) |
Primary outcome
operative time
Time frame: 60 minutes
time taken from start of operation till its end
blood loss
Time frame: during surgery time
amount in CC
occurrence of major complications as vascular injury or ureteric injury
Time frame: during surgery
injury
urinary retention
Time frame: 24 hours
inability to pass urine after catheter removal
hospital stay duration
Time frame: 24 hours
how many hours patient stay in hospital after procedure till discharge
2 secondary outcomes
occurrence of relapse
Time frame: 1year after procedure
erosion
Time frame: 1 year after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Yes
Related trials for Apical Prolapse
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Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
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Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.