An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: Rationale and study protocol for a multicentre randomised clinical study
| Autor: | Diaz-Cambronero, O, Mazzinari, G, Errando, C L, Schultz, M J, Flor Lorente, B, García-Gregorio, N, Vila Montañés, M, Robles-Hernández, Daniel, Olmedilla Arnal, L E, Martín-De-Pablos, A, Marqués Marí, A, Argente Navarro, M P, IPPCollapse-II study group |
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| Přispěvatelé: | Intensive Care Medicine, ACS - Diabetes & metabolism, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Laparoscopic surgery
medicine.medical_specialty Pneumoperitoneum pressure Time Factors Colon medicine.medical_treatment MEDLINE Medicine (miscellaneous) Outcome (game theory) Clinical study Study Protocol 03 medical and health sciences Postoperative complications 0302 clinical medicine Statistical Analysis Plan Pneumoperitoneum 030202 anesthesiology Colorectal surgery medicine Pressure Humans Multicenter Studies as Topic Pharmacology (medical) Single-Blind Method 030212 general & internal medicine Digestive System Surgical Procedures Outcome Randomized Controlled Trials as Topic Protocol (science) lcsh:R5-920 business.industry General surgery Rectum Recovery of Function Length of Stay medicine.disease 3. Good health Treatment Outcome Spain Abdominal laparoscopy Laparoscopy Post-operative Quality of Recovery Scale (PQRS) Safety lcsh:Medicine (General) business Pneumoperitoneum Artificial |
| Zdroj: | Trials, Vol 20, Iss 1, Pp 1-13 (2019) Trials Trials, 20(1):190. BioMed Central |
| DOI: | 10.1186/s13063-019-3255-1 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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