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NCT01581905 · ClinicalTrials.gov registry record · NA
Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
A NA study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 98
- Enrollment target
NCT01581905 is a NA study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 98 participants.
The verdict
NCT01581905, a NA study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
Study Summary
Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has also shown the complication rates for laparoscopic cases are similar to open procedures in the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to decrease the learning curve and increase the availability of minimally invasive surgery to patients. A current review of the literature reveals no randomized trials evaluating the efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to address this void. The primary objective of this study is to determine whether Robot-Assisted Laparoscopic Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to operative time, blood loss, an
Interventions
- PROCEDURE Conventional Laparoscopic Hysterectomy (LH)
- PROCEDURE Robot Assisted Hysterectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01581905
The ClinicalTrials.gov registry entry for NCT01581905 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Conventional Laparoscopic Hysterectomy (LH) is the first listed.
NCT01581905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01581905 about?
NCT01581905 is a clinical study titled "Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution". Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was perform...
What is the current status of trial NCT01581905?
This trial is currently terminated. It is a NA study. The enrollment target is 98 participants. The study started on 2012-03. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01581905?
The interventions under investigation include: Conventional Laparoscopic Hysterectomy (LH) (PROCEDURE), Robot Assisted Hysterectomy (PROCEDURE).
Who is sponsoring clinical trial NCT01581905?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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