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A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution


N/A
18 Years
80 Years
Open (Enrolling)
Female
Menorrhagia, Dysfunctional Uterine Bleeding, Leiomyoma, Pelvic Pain, Endometriosis

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Trial Information

A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution


See Above


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Operating Time

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Janis L Green, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Institutional Review Board

Study ID:

38824

NCT ID:

NCT01581905

Start Date:

March 2012

Completion Date:

June 2013

Related Keywords:

  • Menorrhagia
  • Dysfunctional Uterine Bleeding
  • Leiomyoma
  • Pelvic Pain
  • Endometriosis
  • Hysterectomy
  • Laparoscopy
  • Robotics
  • Endometriosis
  • Hemorrhage
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Metrorrhagia
  • Pelvic Pain
  • Uterine Hemorrhage

Name

Location
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033