Small Stitch Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Anterior Vaginal Wall Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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.

Group Type EXPERIMENTAL

small stitch anterior colporrhaphy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No