A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein.

OBJECTIVE: The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. The present study assessed whether radiofrequency ablation (RFA) was noninferior to high ligation and stripping (HLS) and conservative hemodynamic cure for venous insufficiency (CHIVA) for clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VVs) due to great saphenous vein (GSV) insufficiency. METHODS: We performed a randomized, single-center, open-label, controlled, noninferiority trial to compare RFA and 2 surgical techniques for the treatment of primary VVs due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged >18 years with primary VVs and GSV incompetence, with or without clinical symptoms, C2 to C6 CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) clinical class, and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HLS, or CHIVA. The rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety, and quality of life were secondary endpoints. RESULTS: From December 2012 to June 2015, 225 limbs had been randomized to RFA, HLS, or CHIVA (n = 74, n = 75, and n = 76). Clinical follow-up and Doppler ultrasound examinations were performed at 1 week and 1, 6, 12, and 24 months postoperatively. No differences in postoperative complications or pain were observed among the three groups. RFA was noninferior to HLS and CHIVA for clinical recurrence at 24 months, with an estimated difference in recurrence of 3% (95% confidence interval [CI], -4.8% to 10.7%; noninferiority P = .002) and -7% (95% CI, -17% to 3%; P < .001), respectively. For ultrasound recurrence, RFA was noninferior to CHIVA, with an estimated difference of -34% (95% CI, -47% to -20%; noninferiority P < .001) at 24 months. However, noninferiority could not be demonstrated compared with HLS (5.9%; 95% CI, -4.1 to 15.9; P = .073). No differences were found in quality of life among the three groups. CONCLUSIONS: RFA was shown to be noninferior in terms of clinical recurrence to HLS and CHIVA in the treatment of VVs due to GSV insufficiency.

Intra-abdominal pressure as a marker of severity in acute pancreatitis.

BACKGROUND: Acute pancreatitis is one of the main causes of intra-abdominal hypertension, which may lead to multiple physiologic alterations. The aim of this study was to determine the relationship between acute pancreatitis and intra-abdominal hypertension, and to evaluate the utility of intra-abdominal pressure (IAP) as a marker of severity in acute pancreatitis. METHODS: From July 2002 to July 2004, 45 patients admitted for acute pancreatitis were included in this prospective, observational study. The diagnostic criteria for acute pancreatitis were compatible clinical manifestations and a 3-fold increase in serum amylase levels. Severe pancreatitis was defined as Apache II score >or=8. IAP was determined every 12 hours, and the maximum and the mean values were used for analysis and correlated with prognostic factors of acute pancreatitis. RESULTS: A statistical relationship was observed between maximum IAP and the typical prognostic factors of acute pancreatitis. Maximum IAP had a significant relationship with the computed tomography severity index and the number of complementary tests required. The maximum IAP was significantly greater in patients who died and in patients requiring vasoactive drugs, total parenteral nutrition, or operative treatment related to complications. The maximum IAP was also greater in patients who developed systemic inflammatory response syndrome, multiorgan failure, increase in number and/or volume of intra-abdominal collections, those who required aspiration of the necrosis for suspected infection, those who demonstrated the presence of microorganisms, and those with positive blood cultures. CONCLUSION: The maximum IAP is a useful, inexpensive, and easy method to measure prognostic marker of the evolution and complications of acute pancreatitis.