O Díaz-Cambronero1,2,3, G Mazzinari1,2, B Flor Lorente4, N García Gregorio1,2, D Robles-Hernandez5, L E Olmedilla Arnal6, A Martin de Pablos7, M J Schultz8,9,10, C L Errando11, M P Argente Navarro1,2. 1. Research Group in Perioperative Medicine, Castellón, Spain. 2. Department of Anaesthesiology, Castellón, Spain. 3. Spanish Clinical Research Network (SCReN), SCReN-IIS La Fe, PT17/0017/0035, Hospital Universitario y Politécnico la Fe, Castellón, Spain. 4. Department of Colorectal Surgery, Castellón, Spain. 5. Hospital General Universitario de Castellón, Castellón, Spain. 6. Hospital General Universitario Gregorio Marañón, Madrid, Spain. 7. Hospital Universitario Virgen Macarena, Seville, Spain. 8. Department of Intensive Care and Laboratory of Experimental Intensive Care and Anaesthesiology, Amsterdam University Medical Centre, Location AMC, Amsterdam, The Netherlands. 9. Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand. 10. Nuffield Department of Medicine, University of Oxford, Oxford, UK. 11. Department of Anaesthesiology, Consorcio Hospital General Universitario de Valencia, Valencia, and Departments of Anaesthesiology, Castellón, Spain.
Abstract
BACKGROUND: It remains uncertain whether individualization of pneumoperitoneum pressures during laparoscopic surgery improves postoperative recovery. This study compared an individualized pneumoperitoneum pressure (IPP) strategy with a standard pneumoperitoneum pressure (SPP) strategy with respect to postoperative recovery after laparoscopic colorectal surgery. METHODS: This was a multicentre RCT. The IPP strategy comprised modified patient positioning, deep neuromuscular blockade, and abdominal wall prestretching targeting the lowest intra-abdominal pressure (IAP) that maintained acceptable workspace. The SPP strategy comprised patient positioning according to the surgeon's preference, moderate neuromuscular blockade and a fixed IAP of 12 mmHg. The primary endpoint was physiological postoperative recovery, assessed by means of the Postoperative Quality of Recovery Scale. Secondary endpoints included recovery in other domains and overall recovery, the occurrence of intraoperative and postoperative complications, duration of hospital stay, and plasma markers of inflammation up to postoperative day 3. RESULTS: Of 166 patients, 85 received an IPP strategy and 81 an SPP strategy. The IPP strategy was associated with a higher probability of physiological recovery (odds ratio (OR) 2·77, 95 per cent c.i. 1·19 to 6·40, P = 0·017; risk ratio (RR) 1·82, 1·79 to 1·87, P = 0·049). The IPP strategy was also associated with a higher probability of emotional (P = 0·013) and overall (P = 0·011) recovery. Intraoperative adverse events were less frequent with the IPP strategy (P < 0·001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0·029). Other endpoints were not affected. CONCLUSION: In this cohort of patients undergoing laparoscopic colorectal surgery, an IPP strategy was associated with faster recovery, fewer intraoperative complications and less inflammation than an SPP strategy. Registration number: NCT02773173 ( http://www.clinicaltrials.gov).
RCT Entities:
BACKGROUND: It remains uncertain whether individualization of pneumoperitoneum pressures during laparoscopic surgery improves postoperative recovery. This study compared an individualized pneumoperitoneum pressure (IPP) strategy with a standard pneumoperitoneum pressure (SPP) strategy with respect to postoperative recovery after laparoscopic colorectal surgery. METHODS: This was a multicentre RCT. The IPP strategy comprised modified patient positioning, deep neuromuscular blockade, and abdominal wall prestretching targeting the lowest intra-abdominal pressure (IAP) that maintained acceptable workspace. The SPP strategy comprised patient positioning according to the surgeon's preference, moderate neuromuscular blockade and a fixed IAP of 12 mmHg. The primary endpoint was physiological postoperative recovery, assessed by means of the Postoperative Quality of Recovery Scale. Secondary endpoints included recovery in other domains and overall recovery, the occurrence of intraoperative and postoperative complications, duration of hospital stay, and plasma markers of inflammation up to postoperative day 3. RESULTS: Of 166 patients, 85 received an IPP strategy and 81 an SPP strategy. The IPP strategy was associated with a higher probability of physiological recovery (odds ratio (OR) 2·77, 95 per cent c.i. 1·19 to 6·40, P = 0·017; risk ratio (RR) 1·82, 1·79 to 1·87, P = 0·049). The IPP strategy was also associated with a higher probability of emotional (P = 0·013) and overall (P = 0·011) recovery. Intraoperative adverse events were less frequent with the IPP strategy (P < 0·001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0·029). Other endpoints were not affected. CONCLUSION: In this cohort of patients undergoing laparoscopic colorectal surgery, an IPP strategy was associated with faster recovery, fewer intraoperative complications and less inflammation than an SPP strategy. Registration number: NCT02773173 ( http://www.clinicaltrials.gov).
Authors: Frank Sterke; Willem van Weteringen; Lorenzo Ventura; Ilaria Milesi; René M H Wijnen; John Vlot; Raffaele L Dellacà Journal: Surg Endosc Date: 2022-07-21 Impact factor: 3.453