Enrique Soto1, Thanh Ha Luu2, Xiaobo Liu3, Javier F Magrina4, Megan N Wasson4, Jon I Einarsson5, Sarah L Cohen5, Tommaso Falcone6. 1. Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; South Florida Institute for Reproductive Medicine, Miami, Florida; Department of Obstetrics and Gynecology, Herbert Wertheim College of Medicine at Florida International University, Miami, Florida. 2. Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio. 3. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. 4. Department of Gynecology, Mayo Clinic Arizona, Scottsdale, Arizona. 5. Department of Minimally Invasive Gynecology, Brigham and Women's Hospital, Boston, Massachusetts. 6. Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: falcont@ccf.org.
Abstract
OBJECTIVE: To determine whether the use of the robot for surgical treatment of endometriosis is better than traditional laparoscopy in terms of operative length, perioperative parameters, and quality of life outcomes. DESIGN: Multicenter, randomized clinical trial. SETTING:University teaching hospitals. PATIENT(S): Women aged >18 years with suspected endometriosis who elected to undergo surgical management. INTERVENTION(S): Randomization to conventional or robot-assisted laparoscopic removal of endometriosis. MAIN OUTCOME MEASURE(S): The primary outcome measured was operative time. Secondary outcomes were perioperative complications and quality of life. RESULT(S): The mean operative time for robotic vs. laparoscopic surgery for endometriosis was 106.6 ± 48.4 minutes vs. 101.6 ± 63.2 minutes. There were no differences in blood loss, intraoperative or postoperative complications, or rates of conversion to laparotomy in the two arms. Both groups reported significant improvement on condition-specific quality of life outcomes at 6 weeks and 6 months. CONCLUSION(S): There were no differences in perioperative outcomes between robotic and conventional laparoscopy. CLINICAL TRIAL REGISTRATION NUMBER: NCT01556204.
RCT Entities:
OBJECTIVE: To determine whether the use of the robot for surgical treatment of endometriosis is better than traditional laparoscopy in terms of operative length, perioperative parameters, and quality of life outcomes. DESIGN: Multicenter, randomized clinical trial. SETTING: University teaching hospitals. PATIENT(S): Women aged >18 years with suspected endometriosis who elected to undergo surgical management. INTERVENTION(S): Randomization to conventional or robot-assisted laparoscopic removal of endometriosis. MAIN OUTCOME MEASURE(S): The primary outcome measured was operative time. Secondary outcomes were perioperative complications and quality of life. RESULT(S): The mean operative time for robotic vs. laparoscopic surgery for endometriosis was 106.6 ± 48.4 minutes vs. 101.6 ± 63.2 minutes. There were no differences in blood loss, intraoperative or postoperative complications, or rates of conversion to laparotomy in the two arms. Both groups reported significant improvement on condition-specific quality of life outcomes at 6 weeks and 6 months. CONCLUSION(S): There were no differences in perioperative outcomes between robotic and conventional laparoscopy. CLINICAL TRIAL REGISTRATION NUMBER: NCT01556204.
Authors: Anna Maria Terho; Johanna Mäkelä-Kaikkonen; Pasi Ohtonen; Outi Uimari; Terhi Puhto; Tero Rautio; Sari Koivurova Journal: BMJ Open Date: 2022-07-18 Impact factor: 3.006