Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse
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Treatments
Details and patient eligibility
About
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients with primary symptomatic uterine prolapse
- ≥ 18 years of age
- Considering pelvic reconstructive surgery
Exclusion criteria
- Unwillingness to be randomized to one of two surgical approaches
- Pregnant or planning to maintain their future fertility
- Unable to have general anesthesia
- Currently undergoing chemotherapy OR has current or history of pelvic radiation
- Previous adverse reaction to synthetic mesh
- Recent history of abnormal paps (past 10 years)
- Cervical or uterine cancers
- Previous hysterectomy
- Previous central vault or uterine prolapse repair
- Uterus ≥ 14 weeks size
- Uterine cancer
- History of significant pelvic adhesive disease
- Elongated cervix (length D to C > 6cm)
- Fibroid ≥ 7cm
- Post menopausal with enlarged uterus
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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