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

Penn State Health

Status: Terminated

Conditions: Pelvic Pain; Dysfunctional Uterine Bleeding; Endometriosis; Leiomyoma; Menorrhagia

Treatments: Procedure: Robot Assisted Hysterectomy; Procedure: Conventional Laparoscopic Hysterectomy (LH)

Study type: Interventional

Funder types: Other

Identifiers

NCT01581905

38824

Details and patient eligibility

About

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.

Full description

See Above

Enrollment: 98 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:Individuals who are not candidates for laparoscopic surgery

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

LH Group

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Laparoscopic Hysterectomy (LH)

RH Group

Active Comparator group

Description:

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

Treatment:

Procedure: Robot Assisted Hysterectomy