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

Abstract

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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3255-1) contains supplementary material, which is available to authorized users.

Effect of reversal of deep neuromuscular block with sugammadex or moderate block by neostigmine on shoulder pain in elderly patients undergoing robotic prostatectomy

“…28,29 Perhaps rather than comparing depth of neuromuscular block or assigned intra-abdominal pressure, future studies may investigate an individualised vs conventional (static) approach to insufflation pressure. 30 We found no difference in DASAIM scores, time to PACU discharge, or postoperative nausea between the two treatment groups. Similarly, there were no differences in POMS scores or hospital LOS.…”

Does deep neuromuscular blockade provide improved outcomes in low pressure laparoscopic colorectal surgery? A single blinded randomized pilot study

“…It is possible that deep neuromuscular blockade is not required for adequate vision in low IAP laparoscopic colorectal surgery, however safety concerns have also led other similar studies and trials to combine low IAP and deep neuromuscular blockade in laparoscopic colorectal surgey. 28,29 Although statistical significance was not achieved for the key outcome of this study, deep neuromuscular block was observed to be potentially advantageous for several of the factors examined. There may be less inflammation associated with deep neuromuscular blockade as the CRP was observed to be lower on day 1 which persisted out to day 3.…”

Effect of an individualized versus standard pneumoperitoneum pressure strategy on postoperative recovery: a randomized clinical trial in laparoscopic colorectal surgery

“…Written informed consent was obtained from all subjects before entering the trial. The study was registered before patient enrolment at EudraCT (study 2016‐001693‐15) and http://clinicaltrials.gov (NCT02773173), and the protocol was prepublished 13 and updated 14 .…”

“…PQRS scores were also analysed as ordinal variables 13 . With this approach there is no dichotomization of PQRS outcomes, and scores are treated as variables in ordered categories.…”