Trial record 5 of 70 for:    Menstruation Disturbances: Clinical Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Timothy A Deimling, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT02118974
First received: April 16, 2014
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Operative Time [ Time Frame: Intra operative ] [ Designated as safety issue: No ]
    The primary end point is difference in operative time


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


Estimated Enrollment: 128
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot-assisted
Robot-assisted hysterectomy
Procedure: Hysterectomy
Hysterectomy
Experimental: Laparoscopic Hysterectomy
Laparoscopic Hysterectomy
Procedure: Hysterectomy
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118974

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

No publications provided

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
Study First Received: April 16, 2014
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Hysterectomy
Robot-assisted
Laparoscopy

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

ClinicalTrials.gov processed this record on August 19, 2014