Status:
TERMINATED
Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy
Lead Sponsor:
The Cleveland Clinic
Conditions:
Vaginal Hysterectomy
Laparoscopic Supracervical Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The primary objective of the proposed study is to determine the difference in surgical time between minimally invasive (laparoscopic) sacrocolpopexy performed with concurrent vaginal hysterectomy vers...
Detailed Description
Study Procedures: Study Identification and Recruitment Potential subjects will be identified by members of the Center for Urogynecology \& Pelvic Reconstructive Surgery at the Cleveland Clinic Main c...
Eligibility Criteria
Inclusion
- Age ≥ 18, who are to undergo laparoscopic sacrocolpopexy for uterovaginal prolapse and desire concurrent hysterectomy at the time of surgery
- Other concomitant laparoscopic or prolapse and anti-incontinence procedures (cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.
- Patient's must have an up-to-date PAP smear on record, or a PAP smear is performed in the office and verified to be normal pre-enrollment
Exclusion
- Inability to comprehend written and/or spoken English
- Inability to provide informed consent
- Medical illness precluding laparoscopy
- Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
- Sacrocolpoperineopexy
- Patients desiring uterine preservation (hysteropexy)
- Previous apical prolapse surgery (hysteropexy)
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04797585
Start Date
March 16 2021
End Date
September 12 2023
Last Update
September 19 2024
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195