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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 center dot 77, 95 per cent c.i. 1 center dot 19 to 6 center dot 40, P = 0 center dot 017; risk ratio (RR) 1 center dot 82, 1 center dot 79 to 1 center dot 87, P = 0 center dot 049). The IPP strategy was also associated with a higher probability of emotional (P = 0 center dot 013) and overall (P = 0 center dot 011) recovery. Intraoperative adverse events were less frequent with the IPP strategy (P < 0 center dot 001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0 center dot 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 ( ).

After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.

Background: A recent study shows that a multifaceted strategy using an individualised intra-abdominal pressure titration strategy during colorectal laparoscopic surgery results in an acceptable workspace at low intra-abdominal pressure in most patients. The multifaceted strategy, focused on lower to individualised intra-abdominal pressures, includes prestretching the abdominal wall during initial insufflation, deep neuromuscular blockade, low tidal volume ventilation settings and a modified lithotomy position. The study presented here tests the hypothesis that this strategy improves outcomes of patients scheduled for colorectal laparoscopic surgery. Methods: The Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery versus Standard Therapy (IPPCollapse-II) study is a multicentre, two-arm, parallel-group, single-blinded randomised 1:1 clinical study that runs in four academic hospitals in Spain. Patients scheduled for colorectal laparoscopic surgery with American Society of Anesthesiologists classification I to III who are aged > 18 years and are without cognitive deficits are randomised to an individualised pneumoperitoneum pressure strategy (the intervention group) or to a conventional pneumoperitoneum pressure strategy (the control group). The primary outcome is recovery assessed with the Post-operative Quality of Recovery Scale (PQRS) at postoperative day 1. Secondary outcomes include PQRS score in the post anaesthesia care unit and at postoperative day 3, postoperative complications until postoperative day 28, hospital length of stay and process-related outcomes. Discussion: The IPPCollapse-II study will be the first randomised clinical study that assesses the impact of an individualised pneumoperitoneum pressure strategy focused on working with the lowest intra-abdominal pressure during colorectal laparoscopic surgery on relevant patient-centred outcomes. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance for optimising the care and safety of laparoscopic abdominal surgery. Selection of patient-reported outcomes as the primary outcome of this study facilitates the translation into clinical practice. Access to source data will be made available through anonymised datasets upon request and after agreement of the Steering Committee of the IPPCollapse-II study.

BackgroundWhile guidelines for laparoscopic abdominal surgery advise using the lowest possible intra-abdominal pressure, commonly a standard pressure is used. We evaluated the feasibility of a predefined multifaceted individualized pneumoperitoneum strategy aiming at the lowest possible intra-abdominal pressure during laparoscopic colorectal surgery.MethodsMulticenter prospective study in patients scheduled for laparoscopic colorectal surgery. The strategy consisted of ventilation with low tidal volume, a modified lithotomy position, deep neuromuscular blockade, pre-stretching of the abdominal wall, and individualized intra-abdominal pressure titration; the effect was blindly evaluated by the surgeon. The primary endpoint was the proportion of surgical procedures completed at each individualized intra-abdominal pressure level. Secondary endpoints were the respiratory system driving pressure, and the estimated volume of insufflated CO2 gas needed to perform the surgical procedure.ResultsNinety-two patients were enrolled in the study. Fourteen cases were converted to open surgery for reasons not related to the strategy. The intervention was feasible in all patients and well-accepted by all surgeons. In 61 out of 78 patients (78%), surgery was performed and completed at the lowest possible IAP, 8mmHg. In 17 patients, IAP was raised up to 12mmHg. The relationship between IAP and driving pressure was almost linear. The mean estimated intra-abdominal CO2 volume at which surgery was performed was 3.2L.ConclusionA multifaceted individualized pneumoperitoneum strategy during laparoscopic colorectal surgery was feasible and resulted in an adequate working space in most patients at lower intra-abdominal pressure and lower respiratory driving pressure.ClinicalTrials.gov (Trial Identifier: NCT03000465).