Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy

Area of Science:

• Minimally Invasive Gynecologic Surgery
• Surgical Technology
• Comparative Effectiveness Research

Background:

• Hysterectomy is a common gynecologic procedure.
• Laparoscopic techniques offer minimally invasive options.
• Robot-assisted surgery is increasingly adopted in gynecology.

Purpose of the Study:

• To compare the operative time between robot-assisted laparoscopic hysterectomy and standard laparoscopic hysterectomy.
• To determine if robot-assisted laparoscopic hysterectomy is non-inferior to standard laparoscopic hysterectomy in terms of operative time.

Main Methods:

• Prospective, randomized controlled trial.
• 72 patients randomized to robot-assisted or standard laparoscopic hysterectomy.
• Primary outcome: total operative time; non-inferiority defined as a difference ≤ 15 minutes.

Main Results:

• Mean operative time for robot-assisted: 73.9 minutes.
• Mean operative time for standard laparoscopic: 74.9 minutes.
• The upper bound of the 95% CI for the difference was 6.6 minutes, meeting the non-inferiority margin.

Conclusions:

• Robot-assisted laparoscopic hysterectomy is non-inferior to standard laparoscopic hysterectomy in operative time.
• Experienced surgeons can achieve comparable operative times with both techniques.
• ClinicalTrials.gov identifier: NCT02118974.