Dataset Information

Prospective randomized controlled trial on comparison of standard CO₂ pressure pneumoperitoneum insufflator versus AirSeal®.

ABSTRACT:

Background

AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO₂ recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO₂ insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO₂ insufflators in patients undergoing the most frequently performed laparoscopic procedures.

Methods

One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO₂ insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay.

Results

Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.

Conclusion

This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO₂ insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).

SUBMITTER: Luketina R

PROVIDER: S-EPMC7412773 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionIt has been previously demonstrated that the rise of intra-abdominal pressures and prolonged exposure to such pressures can produce changes in the cardiovascular and pulmonary dynamic which, though potentially well tolerated in the majority of healthy patients with adequate cardiopulmonary reserve, may be less well tolerated when cardiopulmonary reserve is poor. Nevertheless, theoretically lowering intra-abdominal pressure could reduce the impact of pneumoperitoneum on the blood circulation of intra-abdominal organs as well as cardiopulmonary function. However, the evidence remains weak, and as such, the debate remains unresolved. The aim of this systematic review and meta-analysis was to demonstrate the current knowledge around the effect of pneumoperitoneum at different pressures levels during laparoscopic cholecystectomy.Materials and methodsThis systematic review and meta-analysis were reported according to the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines, and the Cochrane handbook for systematic reviews of interventions.ResultsThis systematic review and meta-analysis included 44 randomized controlled trials that compared different pressures of pneumoperitoneum in the setting of elective laparoscopic cholecystectomy. Length of hospital, conversion rate, and complications rate were not significantly different, whereas statistically significant differences were observed in post-operative pain and analgesic consumption. According to the GRADE criteria, overall quality of evidence was high for intra-operative bile spillage (critical outcome), overall complications (critical outcome), shoulder pain (critical outcome), and overall post-operative pain (critical outcome). Overall quality of evidence was moderate for conversion to open surgery (critical outcome), post-operative pain at 1 day (critical outcome), post-operative pain at 3 days (important outcome), and bleeding (critical outcome). Overall quality of evidence was low for operative time (important outcome), length of hospital stay (important outcome), post-operative pain at 12 h (critical outcome), and was very low for post-operative pain at 1 h (critical outcome), post-operative pain at 4 h (critical outcome), post-operative pain at 8 h (critical outcome), and post-operative pain at 2 days (critical outcome).ConclusionsThis review allowed us to draw conclusive results from the use of low-pressure pneumoperitoneum with an adequate quality of evidence.

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:ObjectiveTo study the effects of intra-abdominal pressure on the quality of recovery and innate cytokine production capacity after laparoscopic colorectal surgery within the enhanced recovery after surgery program.BackgroundThere is increasing evidence for the safety and advantages of low-pressure pneumoperitoneum facilitated by deep neuromuscular blockade (NMB). Nonetheless, there is a weak understanding of the relationship between clinical outcomes, surgical injury, postoperative immune dysfunction, and infectious complications.MethodsRandomized controlled trial of 178 patients treated at standard-pressure pneumoperitoneum (12 mm Hg) with moderate NMB (train-of-four 1-2) or low pressure (8 mm Hg) facilitated by deep NMB (posttetanic count 1-2). The primary outcome was the quality of recovery (Quality of Recovery 40 questionnaire) on a postoperative day 1 (POD1). The primary outcome of the immune substudy (n=100) was ex vivo tumor necrosis factor α production capacity upon endotoxin stimulation on POD1.ResultsQuality of Recovery 40 score on POD1 was significantly higher at 167 versus 159 [mean difference (MD): 8.3 points; 95% confidence interval (CI): 2.5, 14.1; P =0.005] and the decline in cytokine production capacity was significantly less for tumor necrosis factor α and interleukin-6 (MD: -172 pg/mL; 95% CI: -316, -27; P =0.021 and MD: -1282 pg/mL; 95% CI: -2505, -59; P =0.040, respectively) for patients operated at low pressure. Low pressure was associated with reduced surgical site hypoxia and inflammation markers and circulating damage-associated molecular patterns, with a less impaired early postoperative ex vivo cytokine production capacity. At low pressure, patients reported lower acute pain scores and developed significantly less 30-day infectious complications.ConclusionsLow intra-abdominal pressure during laparoscopic colorectal surgery is safe, improves the postoperative quality of recovery and preserves innate immune homeostasis, and forms a valuable addition to future enhanced recovery after surgery programs.

Project description:BACKGROUND:Laparoscopic nephrectomy is a preferred technique for living kidney donation. However, positive-pressure pneumoperitoneum may have an unfavorable effect on the remaining kidney and other distant organs due to inflamed vascular endothelium and renal tubular cell injury in response to increased systemic inflammation. Early detection of vascular endothelial and renal tubular response is needed to prevent further kidney injury due to increased intraabdominal pressure induced by pneumoperitoneum. Transperitoneal laparoscopic living donor nephrectomy represented a human model of mild increasing intraabdominal pressure. This study aimed to assess the effect of increased intraabdominal pressure on vascular endothelium and renal tubular cells by comparing the effects of low and standard pressure pneumoperitoneum on vascular endothelial growth factor receptor-2 (VEGFR-2) expression and the shedding of syndecan-1 as the early markers to a systemic inflammation. METHODS:We conducted a prospective randomized study on 44 patients undergoing laparoscopic donor nephrectomy. Subjects were assigned to standard (12?mmHg) or low pressure (8?mmHg) groups. Baseline, intraoperative, and postoperative plasma interleukin-6, syndecan-1, and sVEGFR-2 were quantified by ELISA. Syndecan-1 and VEGFR-2 expression were assessed immunohistochemically in renal cortex tissue. Renal tubule and peritubular capillary ultrastructures were examined using electron microscopy. Perioperative hemodynamic changes, end-tidal CO2, serum creatinine, blood urea nitrogen, and urinary KIM-1 were recorded. RESULTS:The low pressure group showed lower intra- and postoperative heart rate, intraoperative plasma IL-6, sVEGFR-2 levels and plasma syndecan-1 than standard pressure group. Proximal tubule syndecan-1 expression was higher in the low pressure group. Proximal-distal tubules and peritubular capillary endothelium VEGFR-2 expression were lower in low pressure group. The low pressure group showed renal tubule and peritubular capillary ultrastructure with intact cell membranes, clear cell boundaries, and intact brush borders, while standard pressure group showed swollen nuclei, tenuous cell membrane, distant boundaries, vacuolizations, and detached brush borders. CONCLUSION:The low pressure pneumoperitoneum attenuated the inflammatory response and resulted in reduction of syndecan-1 shedding and VEGFR-2 expression as the renal tubular and vascular endothelial proinflammatory markers to injury due to a systemic inflammation in laparoscopic nephrectomy. TRIAL REGISTRATION:ClinicalTrials.gov NCT:03219398, prospectively registered on July 17th, 2017.

Dataset Information

Prospective randomized controlled trial on comparison of standard CO₂ pressure pneumoperitoneum insufflator versus AirSeal®.

Background

Methods

Results

Conclusion

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Dataset Information

Prospective randomized controlled trial on comparison of standard CO2 pressure pneumoperitoneum insufflator versus AirSeal®.

Background

Methods

Results

Conclusion

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OmicsDI is part of the ELIXIR infrastructure

Tweets

Prospective randomized controlled trial on comparison of standard CO₂ pressure pneumoperitoneum insufflator versus AirSeal®.