Small Stitch Study

June 8, 2015 updated by: Halpern Ksenia, Medical University of Vienna

Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Ksenia Halpern, Dr
          • Phone Number: 004314040029150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

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)
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.
4-6 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Engelbert Hanzal, Dr, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1236/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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