NCT02469584

Small Stitch Study

Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Vaginal Wall Prolapse

Interventions

Type	Name	Description
PROCEDURE	small stitch anterior colporrhaphy	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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-06-11
• Last updated: 2015-06-11

Locations

1 site across 1 country: Austria