Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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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, and hospital stay. The investigator's secondary objective was to assess the cost, morbidity, and mortality of each procedure.

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Detailed Description

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See Above

Conditions

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Menorrhagia Dysfunctional Uterine Bleeding Leiomyoma Pelvic Pain Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LH Group

The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.

Group Type ACTIVE_COMPARATOR

Conventional Laparoscopic Hysterectomy (LH)

Intervention Type PROCEDURE

Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.

RH Group

The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.

Group Type ACTIVE_COMPARATOR

Robot Assisted Hysterectomy

Intervention Type PROCEDURE

Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.

Interventions

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Conventional Laparoscopic Hysterectomy (LH)

Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.

Intervention Type PROCEDURE

Robot Assisted Hysterectomy

Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.

Intervention Type PROCEDURE

Other Intervention Names

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LH Group RH Group

Eligibility Criteria

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Inclusion Criteria

* Individuals recruited into this study will be patients presenting to the Urogynecology and Minimally Invasive Surgical Group for consultation for hysterectomy.

Exclusion Criteria

* Medical Condition that does not allow pneumoperitoneum
* Medical Condition that does not allow proper ventilation during anesthesia
* Uterine size precluding access to the uterine artery
* Pelvic Organ Prolapse amendable to a vaginal approach

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes