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A novel abdominal wall entry suction device to increase Veress needle safety: A prospective cohort pilot study.

ABSTRACT: Background:In laparoscopic surgery, the Veress needle technique is most often used to initiate a pneumoperitoneum. Although low, entry-related injuries of the intestines and major vascular structures occur in 0.04-0.1% of cases. Up to 50% of these injuries remain undiagnosed at the time of surgery, resulting in mortality rates between 2.5 and 30%. In an effort to minimize such injuries we objectively assessed a novel abdominal wall entry suction device (AWESD) that was hypothesized to lift the abdominal wall and create an additional post-peritoneum safe margin for safer Veress needle introduction. Materials and methods:A prospective pilot study was conducted in which CT-scans with and without AWESD application (centered above the umbilicus) were assessed to determine its effect on the distance from the linea alba to the intestines, vena cava and abdominal aorta. Paired measurements were subjected to the Wilcoxon signed rank test. Results:Twelve participants were included. The AWESD significantly increased the median distance towards the intestines in the axial and sagittal plane (P?=?0.01 and P?=?0.006) from 0.93 (Inter Quartile Range (IQR): 0.33-1.51) and 0.85 (IQR: 0.32-1.47) to 1.35 (IQR: 0.39-2.27) and 1.25 (IQR: 0.42-2.10) centimeters, respectively. Similarly, for the median axial distances towards the vena cava and abdominal aorta (both P?=?0.002) that were increased from 10.00 (IQR: 7.18-11.12) and 9.33 (IQR: 6.55-10.28) to 13.23 (IQR: 11.76-14.31) and 12.49 (IQR: 10.98-13.32) centimeters, respectively. Conclusion:The AWESD significantly increased the distances between the peritoneum and main intra-abdominal structures. However, conclusions on subsequent increased safety cannot be drawn as high-volume studies are required to determine its clinical relevance.

SUBMITTER: Daemen JHT

PROVIDER: S-EPMC6804323 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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A novel abdominal wall entry suction device to increase Veress needle safety: A prospective cohort pilot study.

Daemen Jean H T JHT Deden Laura N LN van den Ende Anneline A Pijl Milan E J MEJ Slump Cornelis H CH Berends Frits J FJ Aarts Edo O EO

Annals of medicine and surgery (2012) 20191007

<h4>Background</h4>In laparoscopic surgery, the Veress needle technique is most often used to initiate a pneumoperitoneum. Although low, entry-related injuries of the intestines and major vascular structures occur in 0.04-0.1% of cases. Up to 50% of these injuries remain undiagnosed at the time of surgery, resulting in mortality rates between 2.5 and 30%. In an effort to minimize such injuries we objectively assessed a novel abdominal wall entry suction device (AWESD) that was hypothesized to li ...[more]

PMID: 31645941

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Project description:BackgroundThe process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).MethodsWe used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.ResultsWe analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015.ConclusionsA strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.).

Dataset Information

A novel abdominal wall entry suction device to increase Veress needle safety: A prospective cohort pilot study.

Publications

A novel abdominal wall entry suction device to increase Veress needle safety: A prospective cohort pilot study.

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