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Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Repair | Active Comparator | Laparoscopic supracervical hysterectomy with sacropexy |
|
| Vaginal Repair | Active Comparator | Vaginal hysterectomy with uterosacral colposuspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic supracervical hysterectomy with sacropexy | Procedure | Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it |
| Measure | Description | Time Frame |
|---|---|---|
| Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL) | 24 months | |
| Absence of re-treatment for prolapse at 2 years | 24 months | |
| A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" | This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in POPQ measurements | baseline, 6 week, and 3, 12, and 24 months | |
| Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment | EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vatche A Minassian, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham And Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007045 | Hysterectomy, Vaginal |
| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Vaginal hysterectomy with uterosacral colposuspension | Procedure | Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis. |
|
| baseline, 3, 12, and 24 months |
| Change in patient reported sexual questionnaire, PISQ | PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire | baseline, 3, 12 and 24 months |
| Frequencies of surgical and post-operative complications | Complications will be classified and reported, based on severity. | up to 2 years post-operatively |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |