Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-18 @ 8:12 PM
Study NCT ID:
NCT02117492
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2014-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the possible impacts of two techniques of vaginal cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal cuff closure and the impact that these techniques have on vaginal length, sexual function, and overall complication rates.
Detailed Description:
A Validated questionnaire the Female Sexual Function Index (FSFI) and total vaginal lengths will be used to evaluate patients pre-operatively, at 4-6 weeks post-operatively, and 6 months post operatively. The FSFI will also be sent to the patient 12 months post operatively. These data will be used to assess sexual function and total vaginal length in patients undergoing minimally invasive hysterectomy. The study endpoint will occur after the 12 month follow-up questionnaire. Additionally, all complications following surgery will be tracked over the study period for comparison.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: