Abstract
To avoid CO2 pneumoperitoneum-associated cardiopulmonary side-effects during conventional laparoscopic surgeries, we have developed a gasless laparoscopic operation field formation (LOFF) device for laparoendoscopic single-site surgery. The aim of this study is to analyze the safety and efficacy of the LOFF device for laparoendoscopic single-site cholecystectomy and to verify its advantage of avoiding CO2 pneumoperitoneum-associated complications. In this prospective, randomized, observer-blinded clinical trial, eligible participants were randomized in a 1:1 ratio to undergo either conventional CO2 pneumoperitoneum assisted laparoendoscopic single-site cholecystectomy (LESS) or the new gasless LOFF device assisted laparoendoscopic single-site cholecystectomy (LOFF-LESS). Outcomes including intra-operative respiratory and hemodynamic parameters, operation time, conversion rate, complication rate, et al were compared between the two groups. A total of 100 patients were randomized to the LESS group [n = 50; mean (SD) age, 49.5 (13.9) years; 24 (48.0%) women] and the LOFF-LESS group [n = 50, mean (SD) age, 47.4 (13.3) years; 27 (54.0%) women]. Compared with the LOFF-LESS group, the LESS group witnessed significant fluctuations in intra-operative respiratory and hemodynamic parameters. The tracheal extubation time of the LESS group was significantly longer (P = 0.001). The gasless LOFF device is safe and feasible for simple laparoscopic cholecystectomy and has a predominance of avoiding CO2 pneumoperitoneum-associated cardiopulmonary side-effects. Trial registration number: ChiCTR2000033702Graphic abstract
Highlights
The prerequisite of conventional laparoscopic surgery is the establishment of a clear operative space through a small incision in the abdominal wall
With the intention of avoiding the adverse effects of CO2 pneumoperitoneum and retaining the mini-invasive characteristic of laparoscopic surgery at the same time, we designed a new gasless laparoscopic operation field formation (LOFF) device, which achieved success in large laboratory animal experiments [19] and its safety and efficiency were confirmed in clinical application for cholecystectomy [20]
From June 2020, a total of 165 patients were assessed for eligibility of enrollment. 65 patients were excluded for the reasons of not meeting inclusion criteria and declined to participate
Summary
The prerequisite of conventional laparoscopic surgery is the establishment of a clear operative space through a small incision in the abdominal wall. Updates in Surgery wall lifting (AWL) method. Some clinical trials showed that the AWL method was associated with less pulmonary and hemodynamic changes, faster and more uneventful postoperative recovery [12,13,14,15], as well as more abdominal pain, worse exposure, and longer operation time [16,17,18]. With the intention of avoiding the adverse effects of CO2 pneumoperitoneum and retaining the mini-invasive characteristic of laparoscopic surgery at the same time, we designed a new gasless laparoscopic operation field formation (LOFF) device, which achieved success in large laboratory animal experiments [19] and its safety and efficiency were confirmed in clinical application for cholecystectomy [20]. The previous experiments and clinical application demonstrate its safety, efficiency, and advantages of maintaining the stability of circulation, respiratory function and acid–base equilibrium, evidence from prospective randomized clinical trials are still absent
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