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

NCT01581905 | Terminated

• 1 other identifier: 38824
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia; Dysfunctional Uterine Bleeding; Leiomyoma; Pelvic Pain; Endometriosis

Keywords

Hysterectomy; Laparoscopy; Robotics

Outcome Measures

Primary Outcomes (1)

• Operating Time

  Operating time is measured on the day of surgery after completing the procedure.

Secondary Outcomes (6)

• Estimated Blood Loss

  Estimated blood loss will be measured on the day of surgery after completing the procedure.

• Intraoperative Complications

  Intraoperative complications will be measured on the day of surgery after completing the procedure.

• Perioperative Complications

  Perioperative complications will be measured on the date of discharge from the hospital.

• Early Postoperative Complications

  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.

• Delayed Post-Operative Complications

  Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.

Study Arms (2)

LH Group

ACTIVE COMPARATOR

The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.

Procedure: Conventional Laparoscopic Hysterectomy (LH)

RH Group

ACTIVE COMPARATOR

The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.

Procedure: Robot Assisted Hysterectomy

Interventions

Conventional Laparoscopic Hysterectomy (LH) PROCEDURE

Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.

Also known as: LH Group

LH Group

Robot Assisted Hysterectomy PROCEDURE

Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.

Also known as: RH Group

RH Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

• Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr Opin Obstet Gynecol. 2011 Aug;23(4):283-8. doi: 10.1097/GCO.0b013e328348a26e.

  PMID: 21666467 BACKGROUND

• Pasic RP, Rizzo JA, Fang H, Ross S, Moore M, Gunnarsson C. Comparing robot-assisted with conventional laparoscopic hysterectomy: impact on cost and clinical outcomes. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):730-8. doi: 10.1016/j.jmig.2010.06.009. Epub 2010 Sep 17.

  PMID: 20850391 BACKGROUND

• Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. Epub 2008 Mar 6.

  PMID: 18439499 BACKGROUND

• Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.

  PMID: 20207063 BACKGROUND

• Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.

  PMID: 19793478 BACKGROUND

MeSH Terms

Conditions

Menorrhagia; Metrorrhagia; Leiomyoma; Pelvic Pain; Endometriosis

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Janis L Green, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• Gerald J Harkins, MD

  Milton S. Hershey Medical Center

  STUDY DIRECTOR

• Matthew Davies, MD

  Milton S. Hershey Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)