Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse (NCT01594372) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse
Stopped: 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.
United States14 participantsStarted 2013-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: 24 months
2
Absence of re-treatment for prolapse at 2 years
Timeframe: 24 months
3
A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"