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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118974
• Other study ID #: STUDY00000164
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: January 18, 2017
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy
• Menorrhagia
• Pelvic Pain

Intervention

Procedure:
• Hysterectomy
Hysterectomy

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative Time	The primary end point is difference in operative time	Intra operative
Secondary	Complications	Complications related to the procedure including delays in discharge and re-admissions will be monitored and evaluated individually throughout the study.	up to 6 weeks following intervention