Efficacy and safety of a new single-port model for appendectomy : experimental study on swine

Abstract

CONTEXT: With the cooperation of surgeons and the engineering division of the company Bhio supply© (EsteioRS, Brazil), a permanent single port was developed. AIMS: An experimental study assessed the safety and effi cacy of the device using a swine laparoscopic appendectomy model (right salpingo-oophorectomy). SETTINGS AND DESIGN: Experimental randomised study. MATERIALS AND METHODS: A total of 20 pigs were randomised for the conventional laparoscopic (CL) three-trocar technique or the single Centry port (CPort) with two working channels, aided by a transparietal thread. Operative times, surgical complications, CO2 use, and pneumoperitoneal pressure were checked. Pressure and chromopertubation tests assessed the ligatures. STATISTICAL ANALYSIS USED: For quantitative outcomes, the Fisher’s exact test analysed the samples to compare the surgeons in each group, the ANOVA test for parametric data (volume and pressure) and the Student’s t-test for analysis of the fascial incision length. The binaries and isolated occurrence events were described in percentages. RESULTS: For all cases, pneumoperitoneum was maintained. The CPort group, however, resulted in higher CO2 use (26.18 l; standard deviation [SD] ± 11.09) than CL group (5.69 l; SD ± 2.44) (P < 0.01). The mean pressure in CPort group (6.604 mmHg, SD ± 1.793) was comparatively lower than in CL group (7.382 mmHg, SD ± 1.833) (P = 0.363). There was no statistical difference between operative times, ligature safety or adverse surgical events between the different groups and surgeons. CONCLUSION: The surgical technique used with the single port showed no differences in safety and effi cacy. Though it does require more CO2 use, its working dynamics did not lead to increased operative times. The results were similar between the two surgeons in the study, suggesting that they can be reproduced.