Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Vaginal Wall Prolapse
- Sponsor
- Medical University of Vienna
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Halpern Ksenia
Dr.
Medical University of Vienna
Eligibility Criteria
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
Outcomes
Primary Outcomes
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
Time Frame: 4-6 weeks, 3 months
The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.