Shi Chen1,2, Qian Zhan1,3, Jia-Bin Jin1,3, Zhi-Chong Wu1,3, Yuan Shi1,3, Dong-Feng Cheng1,3, Hao Chen1,3, Xia-Xing Deng1,3, Bai-Yong Shen4,5, Cheng-Hong Peng6,7, Hong-Wei Li1,3. 1. Department of General Surgery, Research Institute of Pancreatic Disease, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, People's Republic of China. 2. Department of Hepatobiliary Surgery, Fujian Provincial Hospital, Fujian Medical University, Fuzhou, People's Republic of China. 3. Shanghai Institute of Digestive Surgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, People's Republic of China. 4. Department of General Surgery, Research Institute of Pancreatic Disease, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, People's Republic of China. ruijinsby@hotmail.com. 5. Shanghai Institute of Digestive Surgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, People's Republic of China. ruijinsby@hotmail.com. 6. Department of General Surgery, Research Institute of Pancreatic Disease, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, People's Republic of China. chhpeng@yeah.net. 7. Shanghai Institute of Digestive Surgery, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 197 Ruijin Er Road, Shanghai, 200025, People's Republic of China. chhpeng@yeah.net.
Abstract
OBJECTIVE: This first prospective randomized controlled trial was performed to compare short-term outcomes of robot-assisted laparoscopic middle pancreatectomy (RA-MP) with open middle pancreatectomy (OMP). BACKGROUND:RA-MP is a novel minimally invasive surgical technique for benign or borderline tumors in the pancreatic neck or body. Its short-term effectiveness and safety remain unknown, compared to OMP. METHODS:Patients eligible for MP from August 2011 to November 2015 were randomized into the RA-MP or OMP group. The primary endpoint was length of hospital stay (LOS). Secondary endpoints were intraoperative parameters, and postoperative and recovery variables. RESULTS:A total of 100 patients were included into the study to analyze primary and secondary endpoints. Demographic characteristics and pathological parameters were similar in both groups. Furthermore, LOS was significantly shorter (15.6 vs. 21.7 days, P = 0.002), median operative time was reduced (160 vs. 193 min, P = 0.002), median blood loss was lower (50 vs. 200 mL, P < 0.001), rate of clinical postoperative pancreatic fistula (POPF) was lower (18 vs. 36.0 %, P = 0.043), nutritional status recovery was better, off-bed return to activity was expedited (3.1 vs. 4.6 days, P < 0.001), and resumption of bowel movement was faster (3.5 vs. 5.0 days, P < 0.001) in the RA-MP group, compared to the OMP group. CONCLUSION:RA-MP was associated with significantly shorter LOS, reduced operative time, blood loss and clinical POPF rate, and expedited postoperative recovery, compared to OMP.
RCT Entities:
OBJECTIVE: This first prospective randomized controlled trial was performed to compare short-term outcomes of robot-assisted laparoscopic middle pancreatectomy (RA-MP) with open middle pancreatectomy (OMP). BACKGROUND: RA-MP is a novel minimally invasive surgical technique for benign or borderline tumors in the pancreatic neck or body. Its short-term effectiveness and safety remain unknown, compared to OMP. METHODS:Patients eligible for MP from August 2011 to November 2015 were randomized into the RA-MP or OMP group. The primary endpoint was length of hospital stay (LOS). Secondary endpoints were intraoperative parameters, and postoperative and recovery variables. RESULTS: A total of 100 patients were included into the study to analyze primary and secondary endpoints. Demographic characteristics and pathological parameters were similar in both groups. Furthermore, LOS was significantly shorter (15.6 vs. 21.7 days, P = 0.002), median operative time was reduced (160 vs. 193 min, P = 0.002), median blood loss was lower (50 vs. 200 mL, P < 0.001), rate of clinical postoperative pancreatic fistula (POPF) was lower (18 vs. 36.0 %, P = 0.043), nutritional status recovery was better, off-bed return to activity was expedited (3.1 vs. 4.6 days, P < 0.001), and resumption of bowel movement was faster (3.5 vs. 5.0 days, P < 0.001) in the RA-MP group, compared to the OMP group. CONCLUSION: RA-MP was associated with significantly shorter LOS, reduced operative time, blood loss and clinical POPF rate, and expedited postoperative recovery, compared to OMP.
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