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

Not Applicable

Completed

• Conditions: Menorrhagia; Pelvic Pain; Hysterectomy
• Interventions: Procedure: Hysterectomy

• Registration Number: NCT02118974
• Lead Sponsor: Milton S. Hershey Medical Center

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 Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Primary Completion: 2014-10
• Study Completion: 2015-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted	Hysterectomy	Robot-assisted hysterectomy
Laparoscopic Hysterectomy	Hysterectomy	Laparoscopic Hysterectomy

Primary Outcome Measures

Name	Time	Method
Operative Time	Intra operative	The primary end point is difference in operative time

Secondary Outcome Measures

Name	Time	Method
Complications	up to 6 weeks following intervention	Complications related to the procedure including delays in discharge and re-admissions will be monitored and evaluated individually throughout the study.

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States