A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy
Exclusion criteria
- Adults unable to consent
- Children under the age of 18
- Pregnant women
- Prisoners
- Post-menopausal women
- Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
- Patients unable to consent to the procedure in the English language
Trial design
Primary purpose
Allocation
Interventional model
Masking
70 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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