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

This study is currently recruiting participants.
Verified April 2012 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Janis L. Green, MD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01581905
First received: February 24, 2012
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Menorrhagia
Dysfunctional Uterine Bleeding
Leiomyoma
Pelvic Pain
Endometriosis
 Procedure: Conventional Laparoscopic Hysterectomy (LH)
Procedure: Robot Assisted Hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Operating Time [ Time Frame: Operating time is measured on the day of surgery after completing the procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated Blood Loss [ Time Frame: Estimated blood loss will be measured on the day of surgery after completing the procedure. ] [ Designated as safety issue: Yes ]
  • Intraoperative Complications [ Time Frame: Intraoperative complications will be measured on the day of surgery after completing the procedure. ] [ Designated as safety issue: Yes ]
    Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage

  • Perioperative Complications [ Time Frame: Perioperative complications will be measured on the date of discharge from the hospital. ] [ Designated as safety issue: Yes ]
    Perioperative complications include: urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE)

  • Early Postoperative Complications [ Time Frame: Early postoperative complications will be measured on the date of discharge from the hospital until two weeks after surgery, assessed up to 14 days post-operativley. ] [ Designated as safety issue: Yes ]
    Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)

  • Delayed Post-Operative Complications [ Time Frame: Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively. ] [ Designated as safety issue: Yes ]
    Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration

  • Costs [ Time Frame: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively. ] [ Designated as safety issue: No ]
    Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.


Estimated Enrollment: 400
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LH Group
The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.
 Procedure: Conventional Laparoscopic Hysterectomy (LH)
Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
Other Name: LH Group
Active Comparator: RH Group
The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.
 Procedure: Robot Assisted Hysterectomy
Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
Other Name: RH Group

Detailed Description:

See Above

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581905

Contacts
Contact: Janis L Green, MD 717-531-6447 jgreen3@hmc.psu.edu
Contact: Gerald J Harkins, MD 717-531-6447 gharkins@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Gerald J Harkins, MD     717-531-6447     gharkins@hmc.psu.edu    
Principal Investigator: Janis L Green, MD            
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Janis L Green, MD Milton S. Hershey Medical Center
Study Director: Gerald J Harkins, MD Milton S. Hershey Medical Center
Study Chair: Matthew Davies, MD Milton S. Hershey Medical Center
  More Information

Publications:

Responsible Party: Janis L. Green, MD, Faculty, Department of Ob/Gyn, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01581905     History of Changes
Other Study ID Numbers: 38824
Study First Received: February 24, 2012
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Hysterectomy
Laparoscopy
Robotics

Additional relevant MeSH terms:
Uterine Hemorrhage
Endometriosis
Hemorrhage
Leiomyoma
Myofibroma
Menorrhagia
Metrorrhagia
Pelvic Pain
Genital Diseases, Female
Pathologic Processes
 Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Menstruation Disturbances
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013