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Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy

This study has been completed.
Information provided by (Responsible Party):
Timothy A Deimling, Milton S. Hershey Medical Center Identifier:
First received: April 16, 2014
Last updated: January 18, 2017
Last verified: January 2017
Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.

Condition Intervention
Menorrhagia Pelvic Pain Hysterectomy Procedure: Hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy

Resource links provided by NLM:

Further study details as provided by Timothy A Deimling, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Operative Time [ Time Frame: Intra operative ]
    The primary end point is difference in operative time

Secondary Outcome Measures:
  • Complications [ Time Frame: up to 6 weeks following intervention ]
    Complications related to the procedure including delays in discharge and re-admissions will be monitored and evaluated individually throughout the study.

Enrollment: 144
Study Start Date: May 2014
Study Completion Date: April 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot-assisted
Robot-assisted hysterectomy
Procedure: Hysterectomy
Experimental: Laparoscopic Hysterectomy
Laparoscopic Hysterectomy
Procedure: Hysterectomy

Detailed Description:

The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.

The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Undergoing Hysterectomy
  • Able to consent to the procedure

Exclusion Criteria:

  1. Medical conditions not allowing for pneumoperitoneum
  2. Medical conditions not allowing proper ventilation during anesthesia
  3. Pelvic organ prolapse amendable to a vaginal approach
  4. Pregnant women
  5. Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.
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Please refer to this study by its identifier: NCT02118974

United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Timothy A Deimling, Fellow Minimally Invasive GYN Surgery, Milton S. Hershey Medical Center Identifier: NCT02118974     History of Changes
Other Study ID Numbers: STUDY00000164
Study First Received: April 16, 2014
Last Updated: January 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Timothy A Deimling, Milton S. Hershey Medical Center:

Additional relevant MeSH terms:
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes processed this record on September 21, 2017