PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study
Study Details
Study Description
Brief Summary
Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP). This technique has been increasingly used in recent years. However, there is still no data on whether the fixation sutures should be performed with absorbable or non-absorbable threads. Internationally, both types of threads are routinely used and both types of threads are described in publications. So far, there is no comparative data on the effectiveness and subjective results. The aim of this study is to compare subjective symptom improvement Materials & Methods: This is a randomized, single-center superiority study. The sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture. Patients are randomized to either the absorbable PDS sutures group or the non-absorbable Prolene sutures group. The primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific quality of life, and adverse events. 52 patients will be included in the study.
The results of the study will be published in peer-reviewed journals and the results will be presented at scientific meetings.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: PDS - resorbable suture Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. PDS (0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament. |
Procedure: sacrospinous hysteropexy
sacrospinous hysteropexy
|
| Active Comparator: Prolene - non-resorbable sutures Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. Prolene (2-0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament. |
Procedure: sacrospinous hysteropexy
sacrospinous hysteropexy
|
Outcome Measures
Primary Outcome Measures
- Subjective symptom improvement -German version of the pelvic floor questionnaire [12 months post surgery]
subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire)
Secondary Outcome Measures
- anatomical outcomes - POP-Q measurement [12 months post surgery]
anatomical outcomes 12 months after surgery (evaluated through POP-Q-system)
- anatomical outcomes - ultrasound imaging [12 months post surgery]
anatomical outcomes 12 months after surgery (evaluated through ultrasound)
- condition-specific quality of life [12 months post surgery]
condition-specific quality of life 12 months after surgery (evaluated through validated german pelvic floor questionnaire)
- adverse events [12 months post surgery]
assessment of adverse events during the first 12 months after surgery
- Nutritional Assessment [12 months post surgery]
nutritional assessment 12 months after surgery (evaluated through Mini Nutritional Assessment)
- pain VAS [12 months post surgery]
pain assessment 12 months after surgery (evaluated through Visual Analog Scale (VAS))
- pain NRS [12 months post surgery]
pain assessment 12 months after surgery (evaluated through Numeric Rating Scale (NRS))
- Patient Impression of Improvement [12 months post surgery]
patient impression of improvment assessment 12 months after surgery (evaluated throughPatient Global Impression of Improvement (PGI-I))
Eligibility Criteria
Criteria
Inclusion Criteria:
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Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba >0) with central defect
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Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C >0) with central defect
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Symptoms of a vaginal bulge
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A primary reconstructive operation using sacrospinous hysteropexy is planned
Exclusion Criteria:
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Recurrent prolapse
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History of hysterectomy
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A primary reconstructive operation with mesh or obliterative surgery is planned
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An operation with hysterectomy is planned
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Known pelvic malignancy
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Known inflammatory disease
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Current systemic treatment with glucocorticoids or immunosuppressants
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The subject cannot or does not want to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Greta L Carlin, MD, Medical University of Vienna
Study Documents (Full-Text)
More Information
Publications
None provided.- 2079