Small Stitch Study
Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJune 11, 2015
June 1, 2015
10 months
June 5, 2015
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALsymptomatic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- previous urogynecological operation
- gynecologic malignancy
- planned concomitant incontinence operation
- other contraindications for surgery
- pregnancy
- systemic glucocorticoid treatment
- contraindication for the surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Austria, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Engelbert Hanzal, Dr
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 11, 2015
Study Start
October 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 11, 2015
Record last verified: 2015-06