Small Stitch Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study

Conditions
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Anterior Vaginal Wall Prolapse

Intervention / Treatment
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* Procedure: small stitch anterior colporrhaphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women older than 18 years of age Able to read, understand and sign informed consent symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q) Exclusion Criteria: previous urogynecological operation gynecologic malignancy planned concomitant incontinence operation other contraindications for surgery pregnancy systemic glucocorticoid treatment contraindication for the surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: small stitch anterior colporrhaphy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolapse, anterior colporrhaphy