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

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ClinicalTrials.gov Identifier: NCT02118974
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Timothy A Deimling, Milton S. Hershey Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Menorrhagia Pelvic Pain Hysterectomy Procedure: Hysterectomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 144 participants
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
Study Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Robot-assisted
Robot-assisted hysterectomy
Procedure: Hysterectomy
Hysterectomy
Experimental: Laparoscopic Hysterectomy
Laparoscopic Hysterectomy
Procedure: Hysterectomy
Hysterectomy



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


Secondary Outcome Measures :
  1. 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.



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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118974


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy A Deimling, Fellow Minimally Invasive GYN Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02118974     History of Changes
Other Study ID Numbers: STUDY00000164
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Timothy A Deimling, Milton S. Hershey Medical Center:
Hysterectomy
Robot-assisted
Laparoscopy

Additional relevant MeSH terms:
Pelvic Pain
Menorrhagia
Pain
Neurologic Manifestations
Signs and Symptoms
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes