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

January 18, 2017 updated by: Timothy A Deimling, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted
Robot-assisted hysterectomy
Procedure: Hysterectomy
Hysterectomy
Experimental: Laparoscopic Hysterectomy
Procedure: Hysterectomy
Hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: Intra operative
The primary end point is difference in operative time
Intra operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 weeks following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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