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Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

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ClinicalTrials.gov Identifier: NCT01581905
Recruitment Status : Terminated (Trial was redesigned as a new trial)
First Posted : April 20, 2012
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE February 24, 2012
First Posted Date  ICMJE April 20, 2012
Last Update Posted Date January 20, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
Operating Time [ Time Frame: Operating time is measured on the day of surgery after completing the procedure. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01581905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
  • Estimated Blood Loss [ Time Frame: Estimated blood loss will be measured on the day of surgery after completing the procedure. ]
  • Intraoperative Complications [ Time Frame: Intraoperative complications will be measured on the day of surgery after completing the procedure. ]
    Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage
  • Perioperative Complications [ Time Frame: Perioperative complications will be measured on the date of discharge from the hospital. ]
    Perioperative complications include: urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE)
  • Early Postoperative Complications [ Time Frame: Early postoperative complications will be measured on the date of discharge from the hospital until two weeks after surgery, assessed up to 14 days post-operativley. ]
    Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)
  • Delayed Post-Operative Complications [ Time Frame: Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively. ]
    Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration
  • Costs [ Time Frame: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively. ]
    Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
Official Title  ICMJE A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
Brief Summary

Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has also shown the complication rates for laparoscopic cases are similar to open procedures in the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to decrease the learning curve and increase the availability of minimally invasive surgery to patients. A current review of the literature reveals no randomized trials evaluating the efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to address this void.

The primary objective of this study is to determine whether Robot-Assisted Laparoscopic Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to operative time, blood loss, and hospital stay. The investigator's secondary objective was to assess the cost, morbidity, and mortality of each procedure.

Detailed Description See Above
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Menorrhagia
  • Dysfunctional Uterine Bleeding
  • Leiomyoma
  • Pelvic Pain
  • Endometriosis
Intervention  ICMJE
  • Procedure: Conventional Laparoscopic Hysterectomy (LH)
    Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
    Other Name: LH Group
  • Procedure: Robot Assisted Hysterectomy
    Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
    Other Name: RH Group
Study Arms
  • Active Comparator: LH Group
    The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.
    Intervention: Procedure: Conventional Laparoscopic Hysterectomy (LH)
  • Active Comparator: RH Group
    The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.
    Intervention: Procedure: Robot Assisted Hysterectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 19, 2017)
98
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2012)
400
Actual Study Completion Date June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals recruited into this study will be patients presenting to the Urogynecology and Minimally Invasive Surgical Group for consultation for hysterectomy.

Exclusion Criteria:Individuals who are not candidates for laparoscopic surgery

  • Medical Condition that does not allow pneumoperitoneum
  • Medical Condition that does not allow proper ventilation during anesthesia
  • Uterine size precluding access to the uterine artery
  • Pelvic Organ Prolapse amendable to a vaginal approach
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01581905
Other Study ID Numbers  ICMJE 38824
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janis L Green, MD Milton S. Hershey Medical Center
Study Director: Gerald J Harkins, MD Milton S. Hershey Medical Center
Study Chair: Matthew Davies, MD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP