It is reported in the literature article titled ¿natural orifice versus conventional mini laparotomy for specimen extraction after reduced port laparoscopic surgery for colorectal cancer: propensity score matched comparative study¿ patients experienced adverse events during or after procedures using olympus devices.Study background and aim: although reduced port laparoscopic surgery (rpls), defined as laparoscopic surgery performed with the minimum possible number of ports and/or small-sized ports, is less invasive than conventional laparoscopic surgery by reducing the number of surgical wounds, an extension of the incision is still needed for specimen extraction, which can undermine the merits of rpls.The objective of the study was to determine the impact of natural orifice specimen extraction (nose) in patients undergoing rpls for colorectal cancer.The endpoints were perioperative outcome and oncologic safety at 3 years.Setting single-center experience (2013¿2019).Patients we retrospectively analyzed our prospectively collected patient records (american joint committee on cancer (ajcc) stage i¿iii sigmoid or upper rectal cancer (tumor diameter=5 cm) who underwent curative anterior resection via rpls.We excluded patients who did not undergo intestinal anastomosis.Interventions perioperative and oncologic outcomes were compared between patients undergoing natural orifice (rpls-nose) or conventional (mini-laparotomy) specimen extraction (rpls-cse).Patients were matched by propensity scores 1:1 for tumor diameter, ajcc stage, american society of anesthesiologists score and tumor location.Results of 119 eligible patients, 104 were matched (52 rpls-nose; 52 rpls-cse) by propensity scores.Compared with rpls-cse, rpls-nose was associated with longer operative time (223.9 vs.188.7 min; p=0.003), decreased use of analgesics (morphine dose 33.9 vs.43.4 mg; p=0.011) and duration of hospital stay (4.2 vs.5.1 days; p=0.001).No statistically significant difference was found in morbidity or wound-related complication rates between the two groups.After a median follow-up of 34.3 months, no local recurrence was observed in rpls-nose.The 3-year disease-free survival did not differ statistically significantly between groups (90.9 vs.90.5%; p=0.610).Conclusion nose enhances the advantages of rpls by avoiding the need for abdominal wall specimen extraction in patients with tumor diameter=5 cm.Surgical and oncologic safety are comparable to rpls with cse.Operative time was longer for rpls-nose compared to rpls-cse (223.9±51.0 vs.188.7±64.8 min, p=0.003) while there was no statistically significant difference found in blood loss or colorectal anastomosis site.One patient with rpls-nose required conversion to rpls-cse because of failed specimen extraction due to narrow rectal lumen.Although the incidence of intraoperative complications was not statistically significantly different between rpls-nose and rpls-cse (7.7% vs; 1.9%; p=0.169), intraperitoneal fecal contamination during surgery was dominant in rpls-nose group.Return to intestinal activity and duration of hospital stay after surgery were statistically significantly shorter in rpls-nose than in rpls-cse.Overall morbidity was 11.5% without any statistically significant difference between groups.Major complications (clavien-dindo classification grades iii/iv) were noted in two patients (anastomotic leakage and intraabdominal abscess) in the rpls-cse group while there were none in the rpls nose group; this difference was not statistically significant.No mortality was recorded within 30 days after operation; however, two patients in rpls-cse required readmission, one for wound infection and the other for ileus.There is no report of any olympus device malfunction reported in any procedure described in this literature.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.
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