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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.

SUBMITTER: Diaz-Cambronero O

PROVIDER: S-EPMC6446296 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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

Diaz-Cambronero O O Mazzinari G G Errando C L CL Schultz M J MJ Flor Lorente B B García-Gregorio N N Vila Montañés M M Robles-Hernández Daniel D Olmedilla Arnal L E LE Martín-De-Pablos A A Marqués Marí A A Argente Navarro M P MP

Trials 20190403 1

<h4>Background</h4>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 modifi ...[more]

PMID: 30944044

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Project description:BackgroundGas embolism induced by CO2 pneumoperitoneum is commonly identified as a risk factor for morbidity, especially cardiopulmonary morbidity, after laparoscopic liver resection (LLR) in adults. Increasing pneumoperitoneum pressure (PP) contributes to gas accumulation following laparoscopy. However, few studies have examined the effects of PP in the context of LLR. In LLR, the PP-central venous pressure (CVP) gradient is increased due to hepatic vein rupture, hepatic sinusoid exposure, and low CVP management, which together increase the risk of CO2 embolization. The aim of this study is to primarily determine the role of low PP (10 mmHg) on the incidence of severe gas embolism.MethodsAdult participants (n = 140) undergoing elective LLR will be allocated to either a standard (15 mmHg) or low (10 mmHg) PP group. Anesthesia management, postoperative care, and other processes will be performed similarly in both groups. The occurrence of severe gas embolism, which is defined as gas embolism ≥ grade 3 according to the Schmandra microbubble method, will be detected by transesophageal echocardiography (TEE) and recorded as the primary outcome. The subjects will be followed up until discharge and followed up by telephone 1 and 3 months after surgery. Postoperative outcomes, such as the Post-Operative Quality of Recovery Scale, pain severity, and adverse events, will be assessed. Serum cardiac markers and inflammatory factors will also be assessed during the study period. The correlation between intraoperative inferior vena cava-collapsibility index (IVC-CI) under TEE and central venous pressure (CVP) will also be explored.DiscussionThis study is the first prospective randomized clinical trial to determine the effect of low versus standard PP on gas embolism using TEE during elective LLR. These findings will provide scientific and clinical evidence of the role of PP.Trial statusProtocol version: version 1 of 21-08-2020 TRIAL REGISTRATION: ChiCTR2000036396 ( http://www.chictr.org.cn ). Registered on 22 August 2020.

Project description:AimsThe role of laparoscopy in rectal cancer has been questioned. 3D laparoscopic systems are suggested to aid optimal surgical performance but have not been evaluated in advanced procedures. We hypothesised that stereoscopic imaging could improve the performance of laparoscopic total mesorectal excision (TME).MethodsA multicentre developmental randomised controlled trial comparing 2D and 3D laparoscopic TME was performed (ISRCTN59485808). Trial surgeons were colorectal consultants that had completed their TME proficiency curve and underwent stereoscopic visual testing. Patients requiring elective laparoscopic TME with curative intent were centrally randomised (1:1) to 2D or 3D using Karl Storz IMAGE1 S D3-Link™ and 10-mm TIPCAM®1S 3D passive polarising laparoscopic systems. Outcomes were enacted adverse events as assessed by the observational clinical human reliability analysis technique, intraoperative data, 30-day patient outcomes, histopathological specimen assessment and surgeon cognitive load.Results88 patients were included. There were no differences in patient or tumour demographics, surgeon stereopsis, case difficulty, cognitive load, operative time, blood loss or conversion between the trial arms. 1377 intraoperative adverse events were identified (median 18 per case, IQR 14-21, range 2-49) with no differences seen between the 2D and 3D arms (18 (95% CI 17-21) vs. 17 (95% CI 16-19), p?=?0.437). 3D laparoscopy had non-significantly higher mesorectal fascial plane resections (94 vs. 77%, p?=?0.059; OR 0.23 (95% CI 0.05-1.16)) but equal lymph node yield and circumferential margin distance and involvement. 30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms.ConclusionFeasibility of performing multicentre 3D laparoscopic multicentre trials of specialist performed complex procedures is shown. 3D imaging did not alter the number of intraoperative adverse events; however, a potential improvement in mesorectal specimen quality was observed and should form the focus of future 3D laparoscopic TME trials.

Dataset Information

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

Publications

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

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