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A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.
We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC
Objectives
The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.
A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q). The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| small stitch anterior colporrhaphy | Procedure | A midline plication will be performed with continuous delayed absorbable sutures (3-0 polydioxanone) and the distance between the sutures will be 0.5 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score) | The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed. | 4-6 weeks, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ksenia Halpern, Dr | Contact | 00431404040029150 | ksenia.halpern@meduniwien.ac.at | |
| Engelbert Hanzal, DR | Contact | 004314040029150 |
| Name | Affiliation | Role |
|---|---|---|
| Engelbert Hanzal, Dr | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | Austria | 1090 | Austria |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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