Comparison of Low-Pressure and Standard-Pressure Pneumoperitoneum Laparoscopic Cholecystectomy in Patients with Cardiopulmonary Comorbidities: A Double Blinded Randomized Clinical Trial

Abstract

Background The safety and efficacy of low-pressure laparoscopic cholecystectomy (LPLC) in patients with cardiopulmonary comorbidities remain unclear. Methods This was a multicenter, parallel, double-blind, randomized controlled trial performed from January 1, 2019, to January 31, 2023. Eligible patients included patients with cardiac or pulmonary comorbidities, who were randomly assigned (1:1) to undergo LPLC (10 mmHg) or standard-pressure laparoscopic cholecystectomy (SPLC) (14 mmHg). The primary outcome was intraoperative surgeon comfort. Surgical safety variables, patient recovery, and pulmonary function parameters were also compared between groups. Results This study enrolled 144 participants, with 124 participants extracted for the final analysis (62 in LPLC and 62 in SPLC group, respectively). Similar proportion of surgeons reported excellent working space and surgical view (90.3% in the LPLC and 98.4% in the SPLC groups, respectively, p = 0.114). There was no between-group difference regarding intraabdominal operative time, rate of intraoperative bile spillage, blood loss, and conversion rate. Moreover, postoperative major complication rates, the median time to the first flatus, postoperative hospital stay, or mean postoperative visual analog scale score for pain were similar in both groups. Pulmonary parameters including postoperative pH, PaCO₂, HCO₃, and lactate levels were similar between the two comparing groups. Conclusions LPLC with a pneumoperitoneum pressure of 10 mmHg is safe and reasonable for patients with cardiopulmonary comorbidities. Registration: The trial is registered at ClinicalTrials.gov (NCT04670952).