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Clinical Trials/NCT02118974
NCT02118974CompletedNot Applicable

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

Milton S. Hershey Medical Center2 sites in 1 country144 target enrollmentStarted: May 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
2
Primary Endpoint
Operative Time

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Undergoing Hysterectomy
  • Able to consent to the procedure

Exclusion Criteria

  • Medical conditions not allowing for pneumoperitoneum
  • Medical conditions not allowing proper ventilation during anesthesia
  • Pelvic organ prolapse amendable to a vaginal approach
  • Pregnant women
  • Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.

Outcomes

Primary Outcomes

Operative Time

Time Frame: Intra operative

The primary end point is difference in operative time

Secondary Outcomes

  • Complications(up to 6 weeks following intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Timothy A Deimling

Fellow Minimally Invasive GYN Surgery

Milton S. Hershey Medical Center

Study Sites (2)

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