IRB Study Number 20-1293
Status Recruiting
Locations Cleveland Clinic Main Campus, Fairview Medical Office Building, Hillcrest Medical Building Atrium, Fairview Hospital, Hillcrest Hospital
Institute Obstetrics and Gynecology and Women's Health Institute
Description
A prospective randomized trial comparing vaginal hysterectomy and laparoscopic supracervical hysterectomy at the time of sacrocolpopexy for the treatment of uterovaginal prolapse. This study is meant for patients scheduled to undergo laparoscopic sacrocolpopexy for treatment of their prolapse. Only patients with a uterus are eligible for this study. Patients are randomized to two types of hysterectomy at the time of their surgery: vaginal hysterectomy (removal of cervix and uterus) versus laparoscopic hysterectomy (removal of uterus only).
Patient requirements: Questionnaires on the preoperative day, and 6-, 12-, and 24- months following surgery.
Inclusion Criteria
-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 Criteria
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)
