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Prospective Cohort Study Quantifying the Effect of the LevaLap 1.0 on the Distance between the Abdominal Wall and
Franco Orsi1, Daniele Maiettini1, Vincenzo Bagnardi2
1Department of Interventional Radiology (Drs. Orsi and Maiettini), IRCCS Istituto Europeo di Oncologia, Milan, Italy.
Study Objective:
More than 13 million laparoscopic procedures are performed globally every year. The LevaLap 1.0 device may facilitate safe abdominal access when using the Veress needle for initial abdominal insufflation during laparoscopic surgery. We undertook this study to test the hypothesis that use of the LevaLap 1.0 would increase the distance from the abdominal wall to underlying viscera and the retroperitoneum, including from major vessels.
Design:
Prospective cohort study.
Setting:
Referral center.
Patients:
Eighteen patients scheduled to undergo an interventional radiology procedure under general anesthesia and muscle relaxation.
Interventions:
Application of the LevaLap 1.0 device on the umbilicus and on Palmer's point, during computed tomography scanning.
Measurements:
Distance from the abdominal wall to the underlying bowel and to retroperitoneal blood vessels and more distant intra-abdominal organs before and after vacuum was applied to the LevaLap 1.0.
Main Results:
The device did not significantly increase the distance from the abdominal wall to the immediate underlying bowel. Alternatively, the LevaLap 1.0 created a significant increase in the distance between the abdominal wall at the access point and more distant intra-abdominal organs at the umbilicus and at Palmer's point (mean ± SD: +3.91 ± 2.32 cm, p = .001, and +3.41 ± 3.12 cm, p = .001, respectively). At the umbilicus, the device increased the distance between the abdominal wall and the anterior wall of the vena cava by +5.32 ± 1.22 cm (p = .004) or the anterior wall of the aorta by 5.49 ± 1.40 cm (p = .004). At Palmer's point, the device increased the distance between the anterior abdominal wall and the colon and/or small bowel by 2.13 ± 1.81 cm (p = .023). No adverse events were reported.
Conclusions:
The LevaLap 1.0 increased the distance between abdominal wall and major retroperitoneal blood vessels by >5 cm, promoting safer access during Veress needle insufflation when performing laparoscopic surgery.
