Objective:The high prevalence of peritoneal insemination in patients with Advanced Gastric Cancer(AGC)has prompted for more comprehensive multimodality approaches and the combination of curative surgery(CS)and hyperthermic intraperitoneal chemotherapy(HIPEC)gained more recognition over the last few decades.Yet,despite the high efficiency of prophylactic HIPEC,the associated safety issues have made it challenging in clinical practice.In this study,we have focused on the safety issues of the procedure and critically analyzed the procedure-related morbidity of such a multimodality approach in a single-blind randomized controlled trial.Methodology:80 patients were randomly separated into 2 groups where the HIPEC group was treated by CS followed by intraoperative HIPEC with cisplatin 50mg/m2 at 42.2±1.0℃for 30 min while the control group underwent CS alone.The thermoregulation of the extra-corporal heating HIPEC system,including the effect of hyperthermia on the patient’s intracranial temperature and vitals were critically investigated.Post-operative events in the blood physiological and biochemical parameters and clinical recovery and incidence of complications were closely monitored.Results:The thermostability and thermoregulation of the extra-corporal heating HIPEC system was commendable with no intraoperative event reported due to the hyperthermic conditions.Among the 40 HIPEC group patients,the highest intracranial temperature recorded during the procedure was 38.2℃ but the patient made an eventful recovery.There was no incidence of perioperative fever in the HIPEC group(mean temperature was 36.8±0.5℃)but 1 patient presented with mild renal dysfunction,1 manifested hyperbilirubinemia while 1 patient presented with mild liver dysfunction,and upon comparing with the control group,these differences were found to be statistically insignificant(P>0.05).When compared to the control group,bowel function recovery was faster(42.9±4.5 hours,P<0.05)with earlier(liquid fluid intake 3.03±0.28 days,P<0.05)and eventually shorter postoperative stay(P<0.05).Further short-term survival analysis showed that 6 patients from the control group had disease progression with peritoneal insemination while the HIPEC patients were still stable.Conclusion:The results of our study suggest that the combination of intraoperative HIPEC with CS offers better clinical management of patients with high risk of secondary peritoneal carcinomatosis,favoring their post-operative recovery at low incidence of complications and eventually improving their progression free survival rate.Hence,we would recommend prophylactic intraoperative HIPEC as a routine procedure for GC patients with potential serosal invasion. |