Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias.

PURPOSE: Biologic grafts are rarely used for inguinal herniorrhaphy. The aim of this study was to compare the clinical outcomes between patients undergoing a Lichtenstein's hernioplasty with a porcine mesh versus a standard synthetic. METHODS: A prospective, randomized, double-blinded multicenter, evaluation of inguinal hernia repair was conducted between 2008 and 2010. Lichtenstein hernioplasty was performed using Strattice™ or lightweight polypropylene (Ultrapro) mesh. Quality of life, pain, overall complication rate, and recurrence were measured. RESULTS: One hundred and seventy-two patients were randomized to Strattice™ (n = 84) or Ultrapro (n = 88). At 3 months postoperatively, there were no differences on the occurrence or type of wound events [RR: 0.98 (95% CI 0.52-1.86, p = 0.69), Strattice™ (15 events) vs. Ultrapro (16 events)]. The mean level of impairment caused by the hernia, assessed by Activities Assessment Scale (AAS), significantly decreased postoperatively in both groups at 3 months (31% Strattice™ and 37% Ultrapro). Patients in the Strattice group reported significantly less postoperative pain during postoperative days 1 through 3 compared to Ultrapro patients. However, the amount of postoperative pain at 3 months, as assessed by the mean worst pain score on a visual analog scale and the Brief Pain Index, was similar between groups (95% CI 1.0-29.3). No hernia recurrences were observed in either group. CONCLUSIONS: Strattice™ is safe and effective in repairing inguinal hernia, with comparable intra-operative and early postoperative morbidity to synthetic mesh. Long-term follow-up is necessary in order to know whether the clinical outcomes of Strattice are equivalent to standard synthetic mesh in patients undergoing Lichtenstein's hernioplasty.

The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair.

PURPOSE: Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain. METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 men. These men are being followed for a minimum of 2 years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a Lichtenstein inguinal hernia repair as measured by resumption of activities of daily living. Secondary outcomes include chronic pain, postoperative complications and the incidence of re-herniation at 12 and 24 months. RESULTS: This paper discusses the study design, patient recruitment and the current status of the clinical trial. The study involves nine medical centers, all with extensive experience in hernia repair. After 24 months of enrollment, 172 men were randomized and recruitment was then closed. All patients underwent elective repair of primary unilateral inguinal hernias as an outpatient operation. Follow up data are being collected. Data analyses are scheduled at 3, 12, and 24 months postoperatively. CONCLUSION: We report the design of a multi-center, third-party blinded, randomized clinical trial comparing a new surgical device with existing technology in the repair of inguinal hernias. We believe this investigator-designed and conducted trial could serve as a model for similar trials examining surgical devices performed in collaboration with industry.

Ultrasound monitoring of a novel microwave ablation (MWA) device in porcine liver: lessons learned and phenomena observed on ablative effects near major intrahepatic vessels.

BACKGROUND: Microwave ablation (MWA) is postulated to have several advantages over other thermoablative modalities in the treatment of hepatic tumors. Herein, we use an in vivo porcine model to determine the effect of hepatic blood flow on a novel MWA applicator. METHODS: Four 100-kg pigs underwent hepatic MWA (2,450 MHz, 100 W, 4 min) using a 5.7-mm diameter applicator (Microsulis Americas, Sulis V) inserted near large intrahepatic blood vessels. Real-time monitoring was performed using 3, 5, and 12 MHz diagnostic ultrasound transducers. The ablated zones were sectioned for gross and histological processing. RESULTS: Ablation zones were uniform in shape and size (3-4 cm) and related to power deliver only. Gross and microscopic examination revealed direct extension of ablation zones to the margin of major hepatic blood vessels and occasionally beyond the intended target. Of note, a momentary acoustic white-out occurred around the probe at 25 +/- -1 s in every ablation. DISCUSSION: The Sulis V MWA applicator produced uniform zones of ablation that remain unaffected by convective heat loss. The applicator induced a reproducible but temporary event as seen by ultrasound. Further study is warranted to define the physics, benefits, limits, and clinical safety of this new MWA technology.

Use of radiofrequency hepatic parenchymal transection device in hepatic hemangioma resection: early experience and lessons learned.

BACKGROUND: Control of intraoperative hemorrhage represents a significant challenge in hepatic surgery, particularly during resection of large, hypervascular hepatic hemangiomata (HH). Various devices to minimize blood loss from hepatic parenchymal transection are currently under investigation. Herein, we present our experience with a radiofrequency (RF)-powered multiarray for resection of HH. PATIENTS AND METHODS: From September 2005 to January 2006, we conducted a retrospective review of our hepatobiliary database to identify patients with symptomatic giant cavernous HH undergoing resection with a RF multiarray device. The purpose of this review was to assess the technical aspects of using RF energy to assist in the resection of HH. RESULTS: The extent of operation varied depending on the size and location of the tumor. Two patients underwent two atypical subsectionectomies and two underwent trisectionectomies. The Habib sealer provided a safe and effective method for hepatic parenchymal transaction. No patients required blood transfusion, and no injuries to major biliary or vascular strictures were observed at 1 year follow-up. A seroma developed in one patient 6 months postoperatively, but was drained percutaneously. CONCLUSIONS: Hepatic parenchymal transection with the Habib sealer device is a feasible approach to resect HH. Further study is needed to objectively compare the efficacy of RF-assisted parenchymal transection with that of traditional parenchymal transection techniques.

Large scrotal hernia: a complicated case of mesh migration, ascites, and bowel strangulation.

A 30-year-old male with 1 1/2-year history of an asymptomatic, large, reducible right indirect scrotal hernia presented to the emergency department complaining of a 2-week history of increasing abdominal distension and daily emesis. He had recently undergone an emergent exploratory laparotomy in which his asymptomatic hernia was repaired with a mesh plug from an intra-abdominal approach. The mesh plug subsequently migrated into the patient's scrotum resulting in a strangulating bowel obstruction. This paper discusses a serious complication that may result from inappropriate use and placement of a mesh plug and our approach to correct the situation utilizing a bioabsorbable mesh prosthesis.

Omega-3 fatty acid supplementation reduces tumor growth and vascular endothelial growth factor expression in a model of progressive non-metastasizing malignancy.

BACKGROUND: Omega-3 fatty acids, the principal component of fish oil, have been demonstrated to have antiinflammatory properties. The role of eicosapentaenoic acid (EPA) supplementation for cancer patients is currently under investigation; however, the mechanisms of EPA activity have not been defined. The purpose of this study was to characterize tumor-specific and treatment-specific effects of supplemental dietary EPA in an animal model of progressive malignancy. METHODS: Fischer 344 rats (200-250 g) underwent flank implantation of the methycholanthrene (MCA)-induced fibrosarcoma on day 0. Rats were randomly divided into 3 treatment groups on day 13: EPA (1 mL, 5.0 g/kg per day) + 10 IU vitamin E; corn oil (1 mL) + 10 IU vitamin E, and saline (1 mL) + 10 IU vitamin E (vitamin E was used to prevent fatty acid oxidation). On day 14, gavage feeding was started and was continued through day 28. The animals were killed on day 29, and the tumors were removed. The tumors were weighed and divided by the tumor-free carcass weight to obtain percentage of tumor volume, and the livers were flash frozen. Vascular endothelial growth factor-alpha (VEGF-alpha) and cyclo-oxygenase 2 (COX-2) mRNA were measured by reverse transcription-polymerase chain reaction (RT-PCR). RESULTS: EPA rats had significant reductions in tumor volume compared with isocaloric corn oil and control saline animals (25%, p < .01 and 33%, p < .01, respectively). Rats receiving EPA demonstrated decreased VEGF-alpha mRNA levels (0.023 +/- 0 0.001) compared with those receiving corn oil (0.129 +/- 0.047) or saline (0.150 +/- 0.026; p < .05). CONCLUSIONS: These data demonstrate that EPA supplementation inhibits tumor growth, potentially through alterations in the expression of the pro-angiogenic VEGF-alpha. The mechanism(s) of EPA as an inhibitor of tumor-related angiogenic growth factors may be associated with COX-2 enzyme fatty acid metabolism and merits further study.

Palliative strategies for locally advanced unresectable and metastatic pancreatic cancer.

Technical improvement in perioperative morbidity and mortality with improved long-term survival associated with pancreaticoduodenectomy for patients with pancreatic carcinoma has clearly established a role for this operation when performed with curative intent. Most patients with pancreatic adenocarcinoma will not be candidates for surgical resection of their disease. These patients will experience significant symptoms potentially requiring surgical and nonsurgical palliative interventions to treat unrelieved cancer-associated pain, obstructive jaundice, or the development of GOO. The primary goal for palliative interventions should be to relieve symptoms with minimal morbidity and to maintain or improve the quality of life for patients with an expected limited survival.

Transjugular intrahepatic portasystemic shunt vs surgical shunt in good-risk cirrhotic patients: a case-control comparison.

HYPOTHESIS: In good-risk patients with variceal bleeding undergoing portal decompression, surgical shunt is more effective, more durable, and less costly than angiographic shunt (transjugular intrahepatic portasystemic shunt [TIPS]). DESIGN: Retrospective case-control study. SETTING: Academic referral center for liver disease. PATIENTS: Patients with Child-Pugh class A or B cirrhosis with at least 1 prior episode of bleeding from portal hypertension (gastroesophageal varices, portal hypertensive gastropathy). INTERVENTION: Portal decompression by angiographic (TIPS) or surgical (portacaval, distal splenorenal) shunt. MAIN OUTCOME MEASURES: Thirty-day and long-term mortality, postintervention diagnostic procedures (endoscopic, ultrasonographic, and angiographic studies), hospital readmissions, variceal rebleeding episodes, blood transfusions, shunt revisions, and hospital and professional charges. RESULTS: Patients with Child-Pugh class A or B cirrhosis undergoing TIPS (n = 20) or surgical shunt (n = 20) were followed up for 385 and 456 patient-months, respectively. Thirty-day mortality was greater following TIPS compared with surgical shunt (20% vs 0%; P =.20); long-term mortality did not differ. Significantly more rebleeding episodes (P<.001); rehospitalizations (P<.05); diagnostic studies of all types (P<.001); shunt revisions (P<.001); and hospital (P<.005), professional (P<.05), and total (P<. 005) charges occurred following TIPS compared with surgical shunt. CONCLUSIONS: Operative portal decompression is more effective, more durable, and less costly than TIPS in Child-Pugh class A and B cirrhotic patients with variceal bleeding. Good-risk patients with portal hypertensive bleeding should be referred for surgical shunt.

Pancreatic heterotopia and other uncommon causes of non-malignant biliary obstruction.

The vast majority of patients developing obstructive jaundice will have an underlying malignancy. When the etiology of the obstruction cannot be defined prior to operative intervention, identification of a non-malignant process will occur only subsequent to a major operation. The clinical course of a patient with complete distal common bile duct obstruction as the result of pancreatic heterotopia is discussed. This uncommon diagnosis prompted a review of the literature on this subject enabling this detailed discussion inclusive of the embryology, prevalence and clinical presentations of this entity. Our review further identified a varied group of other non-malignant causes of biliary obstruction that may be mistakenly interpreted to represent biliary or pancreatic malignancy.

Nutrient antioxidants in gastrointestinal diseases.

Oxidative stress appears to play a role in the pathogenesis of a number of gastrointestinal disease states, including pancreatitis; gastric and duodenal ulcer disease; IBD; gastric, esophageal, and colon cancers; and hepatic injury secondary to alcohol, metal storage disorders, hepatitis, and ischemia/reperfusion injury. The nutritional antioxidants are attractive potential therapeutic and chemopreventive agents because they are inexpensive and have a relatively low toxicity profile. A word of caution should be noted: Some antioxidants, such as vitamin C, can be prooxidant under certain conditions, and systemically altering the redox state may have untoward effects on the inflammatory response in certain disease states. Thus, at the current time, antioxidant therapy should be restricted to randomized, controlled clinical trials, in which treatment effects can be closely monitored, and therapeutic efficacy can be determined with scientific accuracy.

Effects of transjugular intrahepatic portosystemic shunts on hepatic metabolic function determined with serial monitoring of arterial ketone bodies.

PURPOSE: To investigate the effects of transjugular intrahepatic portosystemic shunt (TIPS) on hepatic metabolic function by measuring serial arterial ketone body ratio (acetoacetate/-hydroxybutyrate; AKBR). MATERIAL AND METHODS: The arterial blood of 30 TIPS patients was assayed before TIPS, 30 minutes after TIPS, and 24 hours after TIPS for acetoacetate, beta-hydroxybutyrate, and glucose. The authors compared the AKBR values to clinical outcome stratified by Child class, emergent versus elective TIPS, and before-TIPS AKBR value < or = 0.5 versus before-TIPS AKBR value > 0.5. RESULTS: A significant change was noted between the AKBR values obtained before TIPS and values 30 minutes after TIPS (0.76 +/- 0.09 vs 0.61 +/- 0.05, P < .05) and between 30 minutes and 24 hours after TIPS (0.81 +/- 0.10, P < .001), but not between the value obtained before TIPS and that obtained 24 hours after TIPS. The 30-day mortality rate in emergency TIPS patients was 50% compared to 7% in the elective TIPS patients (P < .01). The pre-TIPS AKBR values were significantly suppressed in the emergency TIPS patients compared to the elective TIPS patients (0.56 +/- 0.04 vs 0.99 +/- 0.17, P < .005). The 30-day mortality rate in patients with a pre-TIPS AKBR value < or = 0.5 was 75%, which was significantly higher than the 14% rate in patients with a pre-TIPS AKBR value > 0.5 (P < .01). CONCLUSION: A low pre-TIPS AKBR may be predictive of poor outcome after TIPS. Furthermore, AKBR may be of value in determining the timing for performing an elective TIPS.

Enteral vitamin E supplementation inhibits the cytokine response to endotoxin.

OBJECTIVE: To evaluate the effect of short-term, high-dose enteral supplementation of 3 different vitamin E derivatives: free alpha-tocopherol (VE), alpha-tocopherol succinate (VES), and alpha-tocopherol acetate (VEA) on macrophage and monocyte activation. DESIGN: Sprague-Dawley rats (weight, 150-200 g) were assigned to 1 of 5 experimental groups: saline (control), ethanol (control), VES (100 mg/kg), VEA (100 mg/kg), or VE (100 mg/kg). Rats underwent oral gavage once per day for 5 days with 0.5 mL of their assigned solution. All vitamin E derivatives were diluted in 75% ethanol. Rats were then killed and whole-blood and peritoneal macrophages were harvested and stimulated with lipopolysaccharide (10 microg/mL) in vitro. Tumor necrosis factor (TNF) production was measured by enzyme-linked immunosorbent assay. Additional serum samples were analyzed for alpha-tocopherol concentration by high-performance lipid chromatography. RESULTS: Whole-blood TNF production was maximal in the control groups after 3 hours of incubation and began to decline by 6 hours. Supplementation with all 3 vitamin E derivatives resulted in suppression of lipopolysaccharide-induced TNF production at both time points when compared with both ethanol and saline controls (P<.05, analysis of variance [ANOVA]). All 3 vitamin E derivatives also resulted in significant inhibition of lipopolysaccharide-induced TNF production by peritoneal macrophages when compared with their ethanol-carrier control but not with the saline control (P<.05, ANOVA). The degree of TNF suppression correlated directly with serum alpha-tocopherol levels. CONCLUSIONS: Our data demonstrate that a short-term, high-dose enteral supplementation of vitamin E can modulate the monocyte and macrophage response to endotoxin. These data, along with other animal studies showing a protective effect of vitamin E treatment in sepsis and ischemia-reperfusion injury, suggest a potential role for vitamin E supplementation in patients at risk of the systemic inflammatory response syndrome.

Morbid prognostic features in patients with chronic liver failure undergoing nonhepatic surgery.

BACKGROUND: Although the risk of portal decompression surgery is accurately predicted by objective scoring systems (Child classification and Pugh score), few useful prognostic criteria exist regarding nonhepatic surgery in patients with chronic liver failure. OBJECTIVE: To evaluate the clinical findings associated with perioperative mortality in patients with chronic liver failure undergoing nonhepatic surgery. DESIGN: A retrospective cohort study. SETTING: University teaching hospitals. PATIENTS: Forty consecutive patients with an International Classification of Diseases, Ninth Revision (ICD-9), diagnosis of chronic liver failure and one or more of the following: jaundice, cirrhosis, chronic hepatitis, or alcoholism. INTERVENTIONS: Forty operations, including 28 abdominal procedures, 2 coronary artery bypass grafts, 5 orthopedic procedures, and 5 miscellaneous procedures. MAIN OUTCOME MEASURES: Thirty-day mortality as related to 19 preoperative clinical and laboratory variables. RESULTS: Eleven (28%) of the patients died within 30 days of surgery. By univariate analysis, the following variables were significantly (P < .05, pearson chi 2 test for categorical data or Mann-Whitney U test for continuous data) associated with nonsurvival: encephalopathy, congestive heart failure, the need for emergent surgery, infection, hyperbilirubinemia, international normalized ratio greater than 1.6, hypoalbuminemia, and an elevated creatinine level. By multiple logistic regression analysis, an international normalized ratio greater than 1.6 and encephalopathy were associated with a greater than 10- and 35-fold increased mortality risk, respectively. Child classification and Pugh score failed to predict 30-day mortality. CONCLUSIONS: We identified 8 clinical and laboratory variables associated with death within 30 days in patients with chronic liver failure undergoing nonhepatic surgery. Two factors-international normalized ratio greater than 1.6 and encephalopathy-independently predicted mortality by multivariate analysis. Neither Child classification nor Pugh score was prognostically helpful. Nonhepatic surgery confers a substantial mortality risk in patients with chronic liver failure.

Use of laparoscopic techniques improves outcome from adrenalectomy.

BACKGROUND: Laparoscopic adrenalectomy is a promising alternative to open approaches but safety and efficacy remain unproven. METHODS: A recent experience with laparoscopic adrenalectomy at the University of Washington was analyzed for efficacy, complications, evolution of technical steps, and clinical outcome. RESULTS: Nineteen adrenalectomies were performed in 16 patients with a mean age of 52 years. Indications included pheochromocytoma (4), functional adenoma (12), and uncontrolled Cushing's disease (3). All patients had computed tomography scans. Meta-iodo-benzyl-guanidine (MIBG) or iodocholesterol scans were done in selected patients. Three patients had bilateral procedures, 7 were on the left and 6 on the right, all via a transperitoneal flank approach. There were no conversions and all procedures were successful. Complications included subcapsular liver hematomas (2), one transfusion, and a bleeding port site requiring repeat laparoscopy. Except for 1 patient with COPD, the mean length of stay was 2.9 days. CONCLUSIONS: Laparoscopic adrenalectomy in appropriate patients is safe and effective. For endocrine surgeons with advanced laparoscopic skills, it should be considered a new standard therapy for benign adrenal tumors.

Transcatheter arterial embolization of two symptomatic giant cavernous hemangiomas of the liver.

Cavernous hemangiomas are usually asymptomatic; however, a small percentage may cause symptoms. This case report discusses palliation by transcatheter arterial embolization with polyvinyl alcohol particles.