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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: Clinical Trial NA study, sponsored by Milton S. Hershey Medical Center.

NCT01581905 is a NA study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 98 participants
Start Date 2012-03
Est. Completion 2013-06
Phase NA
Milton S. Hershey Medical Center

396 total trials

Why NCT01581905 stopped before completion

NCT01581905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which Conventional Laparoscopic Hysterectomy (LH) is the first listed.

NCT01581905 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01581905's enrollment target sits among peer trials

98 922nd of 2000 higher than 1,078 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01581905, the US trial registry maintained by the National Library of Medicine. NCT01581905 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.