- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03772691
Lateral Suspension and Sacropexy for Pelvic Organ Prolapse
January 27, 2022 updated by: Mohamed Gamal M.fekry, Assiut University
Lateral Suspension Versus Sacropexy for Treatment of Apical Pelvic Organ Prolapse
Pelvic organ prolapse (POP) is considered one of the commonest gynecologic health problems all over the world.
Pelvic organ prolapse (POP) is common and can be seen in up to 50% or more of parous women.
The annual aggregated rate of associated surgery for pelvic organ prolapse is in the range of 10-30 per 10,000 women.
It is estimated that women have an 11-19% life-time risk of undergoing surgery for POP.
This rate is projected to increase over the next 2-3 decades.
Apical POP refers any descent of the cervix or the vaginal cuff scar(as after hysterectomy) below a point which is 2 cm less than the total vaginal length about the plane of the hymen.
Apical POP is due to defect in apical support with damage to the cardinal and uterosacral ligaments.
Apical pelvic organ prolapse is a common issue in our country with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
By one estimate, the demand for health care services related to pelvic floor disorders will increase at twice the rate of the population itself .
So we need adequate understanding of the best surgical method for treating apical POP which is accepted worldwide and also must be cost effective with least perioperative complications.
Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse.
In this technique, the mesh is fixed to the anterior longitudinal ligament at the sacral promontory.
It is used either with uterine preservation (sacrohysteropexy) or after hysterectomy (sacrocolpopexy) for treatment of vault prolapse .However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases.
Postoperative complications include paralytic ileus in 3.6%.transient
femoral nerve injury and vertebral osteomyelitis .
Also, despite that sacropexy provide good apical support, but the high prevalence of cystocele and urinary tract symptoms in patients reaches up to 8% .
Consequently, it is not surprising that the majority of failures following sacrocolpopexy occur in the anterior compartment.
Lateral suspension with mesh was first reported by Dubuisson in 1998 for the treatment of pelvic organ prolapse .
The lateral suspension avoids both the risk of vascular injury and nerve damage of sacrocolpopexy with success rate up to 88% of cases.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Assiut, Egypt, 71111
- Assiut University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Apical prolapse Stage 2-4 according to POP-Q system
- Uterine preservation or after hysterectomy
- Sexually active or not.
Exclusion Criteria:
- Pregnancy or up to 6 months postpartum.
- Current Urinary tract infection proved by urine analysis or urine culture.
- Patient unfit for surgery.
- Previous suspension operations.
- Uncontrolled diabetic patients.
- Urge incontinence.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lateral suspension
All operations will be performed with patient in loyd davies position, sterilization of the perineum then sterilization of the vagina
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• The vesico-vaginal space was found between the bladder and the anterior vaginal wall in the fascia plane.
A polypropylene mesh (25 , 25 cm, Ethicon, Inc., Somerville, NJ) was cut to obtain two long arms (15-20 mm wide) and a rectangular piece (4-7 cm wide).
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Active Comparator: sacropexy
Our first passage is the peritoneum incision overlying the sacral promontory (L5-S1) to expose the anterior longitudinal ligament, which is the anchorage point of the mesh on the sacrum.
We create a tunnel under the peritoneum on the right side through the cul-de-sac of Douglas till reach the cervix or vaginal cuff (after hysterectomy).
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• The mesh is fixed on the anterior longitudinal ligament of sacrum with separated number 1 prolene sutures.
The other end of the mesh is passed through the peritoneal tunnel and fixed to the cervix using prolene 1 and vicryl o sutures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of occurance of denovo stress urinary incontinence
Time Frame: 18 months
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number of patients developed new onset postoperative stress urinary incontinence
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18 months
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The rate of Improvement of urinary symptoms
Time Frame: 18 months
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Improvement of symptoms using Abramsc Development and psychometric evaluation of the International consultation on incontinence and Vaginal Symptoms Questionnaire maximum score:178, minimum score:0 high score means better outcome , low score means worse outcome
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective assessment of prolapse stage
Time Frame: 18 months
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improvement of POP-Q system postoperatively
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18 months
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assessment of sexual function
Time Frame: 18 months
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improvement of female sexual function index postoperatively
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18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
December 9, 2018
First Submitted That Met QC Criteria
December 10, 2018
First Posted (Actual)
December 11, 2018
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pelvic Organ Prolapse
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University of CalgaryAlberta Health services; Cook Group IncorporatedCompletedAnterior Pelvic Organ ProlapseCanada
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University of British ColumbiaCompletedPelvic Organ Prolapse, Patient EducationCanada
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University of MelbourneCompletedVaginal Hysterectomy | Pelvic Organ Prolapse Vaginal SurgeryAustralia
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Unity Health TorontoUnknownVoiding Dysfunction After Pelvic Organ Prolapse SurgeryCanada
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Nykøbing Falster County HospitalZealand University Hospital; University Hospital, Gentofte, Copenhagen; Copenhagen...UnknownBenign Hysterectomy | Postoperative Pelvic Organ Prolapse | Suspension
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