An interventional study of Cuff Closure in Hysterectomy, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vaginal cuff closure will be done vertically.
Procedure: Cuff Closure
Vaginal cuff closure will be done horizontally.
Procedure: Cuff Closure
Closure of the vaginal cuff following hysterectomy.
Vaginal Length
The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, at 4-6 weeks postoperatively.
Time frame: up to 4-6 weeks post-operative
Sexual Function
Secondary outcomes will include sexual function measured with FSFI preoperatively and at 6 months and 12 months post operatively.
Time frame: Pre-operative, 6 and 12 months post-operativey
Complication Rates
Overall complication rates will be monitored.
Time frame: up to 12 months post-operativey
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center