An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical 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.

Trial Registration: ClinicalTrials.gov, NCT02773173 . Registered on 16 May 2016. EudraCT, 2016-001693-15. Registered on 8 August 2016.