Safety Profile of Trocar and Insufflation Needle Access Systems in Laparoscopic Surgery

BACKGROUND: The most common laparoscopic complications are associated with trocar insertion. The purpose of this study was to develop an objective method of evaluating the safety profile of various access devices used in laparoscopic surgery. STUDY DESIGN: In 20 swine, 6 bladed and 2 needle access devices were evaluated. A force profile was determined by measuring the force required to drive the trocar or needle through the fascia and into the peritoneum, at 0 and 10 mmHg. The amount Of tissue deformation, the length of blade exposed, and the duration of exposure were measured using a high-speed digital imaging system. RESULTS: The needle system without the sheath required the least driving force and had the most favorable force profile. In contrast, the bladed, nonretractable trocar system required a higher driving force and a rapid loss of resistance. Insertion under a pneumoperitoneum did not significantly alter the force profile of the various access devices except for the amount of tissue deformation. With the bladed system, the blade itself was exposed for an average of 0.5 to 1.0 seconds for a distance of 4.5 to 5.0 cm. In comparison, the needle system was exposed for 0.2 seconds for a distance of 1.8 cm. CONCLUSIONS: We developed a reproducible method of measuring the forces required to place the access systems, their pattern of resistance loss, and the characteristics of the blade exposure. These parameters may provide an adjunctive and objective measurement of safety, allowing for more direct comparison between various trocar designs. (J Am Coll Surg 2009;209:222-232. (C) 2009 by the American College of Surgeons)

Percutaneous ultrasound-guided renal biopsy in children - safety, efficacy, indications and renal pathology findings: 14-year Brazilian university hospital

Introduction: Pediatric percutaneous renal biopsy (Bx) is a routine procedure in pediatric nephrology to obtain renal tissues for histological study. We evaluated the safety, efficacy, indications and renal findings of this procedure at a tertiary care pediatric university hospital and compared our findings with the literature. Methods: Retrospective study based on medical records from January 1993 to June 2006. Results: In the study period, 305 Bx were performed in 262 patients, 127 (48.5%) male, aged 9.8 +/- 4.2 years. A 16-gauge needle was utilized in 56/305 Bx, an 18-gauge needle in 252/305 Bx (82.6%). 56.1% Bx were performed under sedation plus local anesthesia, 43.9% under general anesthesia. The number of punctures per Bx was 3.1 +/- 1.3. Minor complications occurred in 8.6% procedures. The 16-gauge needle caused a higher frequency of renal hematomas (p = 0.05). The number of glomeruli per puncture was >= 5 in 96.7% and >= 7 in 92%. Glomeruli number per puncture and frequency of complications were not different according to the type of anesthesia used. A renal pathology diagnosis was achieved in 93.1% Bx. The main indications of Bx were nephrotic syndrome (NS), lupus nephritis (LN) and hematuria (HE). The diagnosis of minimal change disease (MCD) (61.3%), class V (35.6%) and IgA nephropathy (26.3%) predominated in NS, LN and HE patients, respectively. Conclusion: Pediatric real-time ultrasound-guided percutaneous renal biopsy was safe and effective. The main clinical indications for Bx were NS and LN, the predominant renal pathology diagnoses were MCD and class V LN.

A pilot study to evaluate the safety, tolerance, and efficacy of a novel stationary antral balloon (SAB) for obesity

Background: A 150 cm(3) pear-shaped gastric balloon with a 30 cm-long duodenal stem and a 7 g metallic weight at its distal end was designed and developed to facilitate weight loss by (a) delaying gastric emptying thus enhancing interprandial satiety, and (b) stimulating antral and duodenal receptors of satiation. Methods: Twenty-six patients (body mass index of 29 to 40 kg/m(2)) who failed to lose weight despite dietary intervention underwent endoscopic implantation of the balloon device. Patients were monitored for tolerance to the balloon, complications, weight loss, and compliance with a restricted caloric intake. Results: Six men and 20 women with a median body weight of 93.0kg (range, 73.5 to 119.9), median body mass index 34.3 kg/m(2) (range, 28.8 to 39.5) underwent balloon implantation for a median period of 4.0 months (range, 0.75 to 6.0). Twenty-two patients successfully complied with a 1250 to 1500 kcal daily diet restriction during the study period. Median weight reduction was 6.5 kg (range, 3.7 to 19.9). Patients with initial body weight of > 90 kg tended to loose more weight (8.1 kg) than patients weighing < 90 kg (4.5 kg) (P = 0.14). Nine patients with dwell times of 6 months lost 11.5 +/- 4.6 kg. The balloon malfunctioned in 4 patients (in I patient, the balloon leaked spontaneously but remained in the stomach and in 3 patients, the balloon migrated distally). Conclusions: Our novel balloon device may be effective in inducing weight loss by promoting compliance with a restricted caloric intake and is well tolerated due to its small size. Complications resulted from balloon rupture, which can be easily prevented by enhancements in design and use of alternative materials.