A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Exclusion Criteria
- Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
- Adults unable to consent
- Post-menopausal women
- ...
- Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
- Adults unable to consent
- Post-menopausal women
- Patients unable to consent to the procedure in the English language
- Pregnant women
- Children under the age of 18
- Prisoners
Summary
- Conditions
- Hysterectomy
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only females
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 t...
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.
Exclusion Criteria
- Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
- Adults unable to consent
- Post-menopausal women
- ...
- Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
- Adults unable to consent
- Post-menopausal women
- Patients unable to consent to the procedure in the English language
- Pregnant women
- Children under the age of 18
- Prisoners
Tracking Information
- NCT #
- NCT02117492
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Timothy A Deimling, MD, MS Milton S. Hershey Medical Center
- Timothy A Deimling, MD, MS Milton S. Hershey Medical Center