Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | January 2013 |
| End Date: | January 2019 |
| Contact: | Rachel Podoski |
| Email: | RPodoski@partners.org |
| Phone: | 617-525-7326 |
Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
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.
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.
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
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