Walter S. Andrews

Thoracoscopic decortication vs tube thoracostomy with fibrinolysis for empyema in children: a prospective, randomized trial

PURPOSE Management of empyema has been debated in the literature for decades. Although both primary video-assisted thoracoscopic surgery (VATS) and tube thoracostomy with pleural instillation of fibrinolytics have been shown to result in early resolution when compared to tube thoracostomy alone, there is a lack of comparative data between these modes of management. Therefore, we conducted a prospective, randomized trial comparing VATS to fibrinolytic therapy in children with empyema. METHODS After Institutional Review Board approval, children defined as having empyema by either loculation on imaging or more than 10,000 white blood cells/microL were treated with VATS or fibrinolysis. Based on our retrospective data using length of postoperative hospitalization as the primary end point, a sample size of 36 patients was calculated for an alpha of .5 and a power of 0.8. Fibrinolysis consisted of inserting a 12F chest tube followed by infusion of 4 mg tissue plasminogen activator mixed with 40 mL of normal saline at the time of tube placement followed by 2 subsequent doses 24 hours apart. RESULTS At diagnosis, there were no differences between groups in age, weight, degree of oxygen support, white blood cell count, or days of symptoms. The outcome data showed no difference in days of hospitalization after intervention, days of oxygen requirement, days until afebrile, or analgesic requirements. Video-assisted thoracoscopic surgery was associated with significantly higher charges. Three patients (16.6%) in the fibrinolysis group subsequently required VATS for definitive therapy. Two patients in the VATS group required ventilator support after therapy, one of whom required temporary dialysis. No patient in the fibrinolysis group clinically worsened after initiation of therapy. CONCLUSIONS There are no therapeutic or recovery advantages between VATS and fibrinolysis for the treatment of empyema; however, VATS resulted in significantly greater charges. Fibrinolysis may pose less risk of acute clinical deterioration and should be the first-line therapy for children with empyema.

Single incision versus standard 3-port laparoscopic appendectomy: a prospective randomized trial.

Background:Laparoscopic appendectomy through a single umbilical incision is an emerging approach supported by several case series. However, to date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing single site umbilical laparoscopic appendectomy to 3-port laparoscopic appendectomy. Methods:After Internal Review Board approval, patients were randomized to laparoscopic appendectomy via a single umbilical incision or standard 3-port access. The primary outcome variable was postoperative wound infection. Using a power of 0.9 and an alpha of 0.05, 180 patients were calculated for each arm. Patients with perforated appendicitis were excluded. The technique of ligation/division of the appendix and mesoappendix was left to the surgeons discretion. There were 7 participating surgeons dictated by the call schedule. All patients received the same preoperative antibiotics and postoperative management was controlled. Results:There were 360 patients were enrolled between August 2009 and November 2010. There were no differences in patient characteristics at presentation. There was no difference in wound infection rate, time to regular diet, length of hospitalization, or time to return to full activity. Operative time, doses of narcotics, surgical difficultly and hospital charges were greater with the single site approach. Also, the mean operative time was 5 minutes longer for the single site group. Conclusion:The single site umbilical laparoscopic approach to appendectomy produces longer operative times resulting in greater charges. However, these small differences are likely of marginal clinical relevance. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).

Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: A Prospective, Randomized Trial

Background:Pyloric stenosis, the most common surgical condition of infants, is treated by longitudinal myotomy of the pylorus. Comparative studies to date between open and laparoscopic pyloromyotomy have been retrospective and report conflicting results. To scientifically compare the 2 techniques, we conducted the first large prospective, randomized trial between the 2 approaches. Methods:After obtaining IRB approval, subjects with ultrasound-proven pyloric stenosis were randomized to either open or laparoscopic pyloromyotomy. Postoperative pain management, feeding schedule, and discharge criteria were identical for both groups. Operating time, postoperative emesis, analgesia requirements, time to full feeding, length of hospitalization after operation, and complications were compared. Results:From April 2003 through March 2006, 200 patients were enrolled in the study. There were no significant differences in operating time, time to full feeding, or length of stay. There were significantly fewer number of emesis episodes and doses of analgesia given in the laparoscopic group. One mucosal perforation and one incisional hernia occurred in the open group. Late in the study, 1 patient in the laparoscopic group was converted to the open operation. A wound infection occurred in 4 of the open patients compared with 2 of the laparoscopic patients (P = 0.68). Conclusions:There is no difference in operating time or length of recovery between open and laparoscopic pyloromyotomy. However, the laparoscopic approach results in less postoperative pain and reduced postoperative emesis. In addition, there was a fewer number of complications in the laparoscopic group. Finally, patients approached laparoscopically will likely display superior cosmetic outcomes with long-term follow-up.

Studies of Pediatric Liver Transplantation (SPLIT) : Year 2000 outcomes

Background. Initiated in 1995, the Studies of Pediatric Liver Transplantation (SPLIT) registry database is a cooperative research network of pediatric transplantation centers in the United States and Canada. The primary objectives are to characterize and follow trends in transplant indications, transplantation techniques, and outcomes (e.g., patient/graft survival, rejection, growth parameters, and immunosuppressive therapy.) Methods. As of June 15, 2000, 29 centers registered 1144 patients, 640 of whom received their first liver-only transplant while registered in SPLIT. Patients are followed every 6 months for 2 years and yearly thereafter. Data are submitted to a central coordinating center. Results. One/two-year patient survival and graft loss estimates are 0.85/0.82 and 0.77/0.72, respectively. Risk factors for death include: in ICU at transplant (relative risk (RR)=2.63, P <0.05) and height/weight deficits of two or more standard deviations (RR=1.67, P <0.05). Risk factors for graft loss include: in ICU at transplant (RR=1.77, P <0.05) and receiving a cadaveric split organ compared with a whole organ (RR=2.3, P <0.05). The percentage of patients diagnosed with hepatic a. and portal v. thrombosis were 9.7% and 7%, respectively; 15% had biliary complications within 30 days. At least one re-operation was required in 45%. One/two-year rejection probability estimates are 0.60/0.66. Tacrolimus, as primary therapy posttransplant, reduces first rejection risk (RR=0.70, P <0.05). Eighty-nine percent of school-aged children are in school full-time, 18 months posttransplant. Conclusions. This report provides one of the first descriptions of characteristics and clinical courses of a multicenter pediatric transplant population. Observations are subject to patient selection biases but are useful for generating hypothesis for future studies.

Initial laparoscopic appendectomy versus initial nonoperative management and interval appendectomy for perforated appendicitis with abscess: a prospective, randomized trial

INTRODUCTION Perforated appendicitis is a common condition in children, which, in a small number of patients, may be complicated by a well-formed abscess. Initial nonoperative management with percutaneous drainage/aspiration of the abscess followed by intravenous antibiotics usually allows for an uneventful interval appendectomy. Although this strategy has become well accepted, there are no published data comparing initial nonoperative management (drainage/interval appendectomy) to appendectomy upon presentation with an abscess. Therefore, we conducted a randomized trial comparing these 2 management strategies. METHODS After internal review board approval (#06 11-164), children who presented with a well-defined abdominal abscess by computed tomographic imaging were randomized on admission to laparoscopic appendectomy or intravenous antibiotics with percutaneous drainage of the abscess (when possible), followed by interval laparoscopic appendectomy approximately 10 weeks later. This was a pilot study with a sample size of 40, which was based on our recent volume of patients presenting with appendicitis and abscess. RESULTS On presentation, there were no differences between the 2 groups regarding age, weight, body mass index, sex distribution, temperature, leukocyte count, number of abscesses, or greatest 2-dimensional area of abscess in the axial view. Regarding outcomes, there were no differences in length of total hospitalization, recurrent abscess rates, or overall charges. There was a trend toward a longer operating time in patients undergoing initial appendectomy (61 minutes versus 42 minutes mean, P = .06). CONCLUSIONS Although initial laparoscopic appendectomy trends toward a requiring longer operative time, there seems to be no advantages between these strategies in terms of total hospitalization, recurrent abscess rate, or total charges.

Mental and motor development, social competence, and growth one year after successful pediatric liver transplantation+

We measured intellectual and motor function, social competence, and growth in 29 children (mean age 4 years 7 months) before liver transplantation and 1 year later. We used either the Bayley Scales, the Stanford-Binet Intelligence Scale, and the Minnesota Child Development Inventory (MCDI), Motor Age Quotient, or the Wechsler Scales, depending on the age of the child at testing. Social function was measured with the MCDI or the Child Behavior Checklist. All anthropometric measures were expressed relative to normal values for age and sex. Patients whose intellectual and motor scores were less than 80 before transplantation gained an average of 8 points, but these changes were not statistically significant, nor were the changes on these measures for the group as a whole. The development of children with onset of liver disease in the first year of life was more likely to remain delayed after transplantation. Older subjects improved significantly in social competence (p less than 0.008). There were significant increments after transplantation in weight, head circumference, and arm anthropometrics (p less than 0.0001 to 0.04), but there was no change in linear growth rate. Increments in length correlated negatively with steroid dosage, and change in head circumference was associated with age at time of transplantation (p less than 0.005 to 0.10).

Single daily dosing ceftriaxone and metronidazole vs standard triple antibiotic regimen for perforated appendicitis in children: a prospective randomized trial

INTRODUCTION Appendicitis is the most common emergency condition in children. Historically, a 3-drug regimen consisting of ampicillin, gentamicin, and clindamycin (AGC) has been used postoperatively for perforated appendicitis. A retrospective review at our institution has found single day dosing of ceftriaxone and metronidazole (CM) to be a more simple and cost-effective antibiotic strategy. Therefore, we performed a prospective, randomized trial to compare efficacy and cost-effectiveness of these 2 regimens. METHODS After internal review board approval (IRB no. 04 12-149), children found to have perforated appendicitis at appendectomy were randomized to either once daily dosing of CM (2 total doses per day) or standard dosing of AGC (11 total doses per day). Perforation was defined as an identifiable hole in the appendix. The operative approach (laparoscopic), length of antibiotic use, and criteria for discharge were standardized for the groups. Based on our retrospective analysis using length of postoperative hospitalization as a primary end point, a sample size of 100 patients was calculated for an alpha of .5 and a power of 0.82. RESULTS One hundred patients underwent laparoscopic appendectomy for perforated appendicitis. On presentation, there were no differences in sex distribution, days of symptoms, temperature, or leukocyte count. There was no difference in abscess rate or wound infections between groups. The CM group resulted in significantly less antibiotic charges then the AGC group. CONCLUSIONS Once daily dosing with the 2-drug regimen (CM) offers a more efficient, cost-effective antibiotic management in children with perforated appendicitis without compromising infection control when compared to a traditional 3-drug regimen.

A complete course of intravenous antibiotics vs a combination of intravenous and oral antibiotics for perforated appendicitis in children: a prospective, randomized trial

INTRODUCTION In a previous prospective randomized trial, we found a once-a-day regimen of ceftriaxone and metronidazole to be an efficient, cost-effective treatment for children with perforated appendicitis. In this study, we evaluated the safety of discharging patients to complete an oral course of antibiotics. METHODS Children found to have perforated appendicitis at the time of laparoscopic appendectomy were enrolled in the study. Perforation was defined as a hole in the appendix or fecalith in the abdomen. Patients were randomized to antibiotic treatment with either once daily dosing of ceftriaxone and metronidazole for a minimum of 5 days (intravenous [IV] arm) or discharge to home on oral amoxicillin/clavulanate when tolerating a regular diet (IV/PO arm) to complete 7 days. RESULTS One hundred two patients underwent laparoscopic appendectomy for perforated appendicitis. On presentation, there were no differences in age, weight, sex distribution, days of symptoms, maximum temperature, or leukocyte count between the 2 groups. There was no difference in the postoperative abscess rate between the two treatment groups. Discharge was possible before day 5 in 42% of the patients in the IV/PO arm. CONCLUSIONS When patients are able to tolerate a regular diet, completing the course of antibiotics orally decreases hospitalization with no effect on the risk of postoperative abscess formation.

Academic outcome in long-term survivors of pediatric liver transplantation

Fifty long-term (3-9 year) survivors of pediatric liver transplantation were assessed using IQ, achievement, and school history measures. Forty-seven of these children had been evaluated before transplantation on intellectual measures, with mean scores for the group found to be in the low average range. At follow-up evaluation, the scores remained in the low average range on all intellectual measures; performance on academic tests was also within the low average range. Thirteen children (26%) were classified as having learning problems based on discrepancies between intellectual and academic function, but only five of them (38%) had received special education services. Nine of the children (18%) had IQ scores less than 70. Academic outcome did not relate to diagnosis, time between diagnosis and transplantation, age at time of transplantation, or average levels of cyclosporin A. Careful assessment and appropriate special education services are indicated to optimize the educational outcome of children who survive liver transplantation.

Hepatocellular carcinoma in children associated with Gardner syndrome or familial adenomatous polyposis.

Purpose Gardner syndrome, a variant of familial adenomatous polyposis, is characterized by colonic polyps that undergo malignant change and benign and malignant extracolonic lesions. Tumors frequently associated with Gardner syndrome include carcinoma of the ampulla of Vater, papillary carcinoma of the thyroid, and, in children, hepatoblastoma. The childhood malignancies often precede the appearance of other manifestations by several years. Patients and Methods Two patients are described. Gardner syndrome was diagnosed in a 15-year-old girl with fibrolamellar hepatocellular carcinoma after desmoid tumors and colonic polyposis developed. Classic hepatocellular carcinoma was also diagnosed in a 9 1/2-year-old boy with familial adenomatous polyposis. Results In patient I, the diagnosis of fibrolamellar hepatocellular carcinoma preceded the diagnosis of Gardner syndrome by almost 2 years. The diagnosis was confirmed by identifying a germline mutation of the adenomatous polyposis coli (APC) gene. This is the first patient reported with fibrolamellar hepatocellular carcinoma associated with Gardner syndrome. Patient 2 had a strong family history of familial adenomatous polyposis but no manifestations of Gardner syndrome. He was not tested for the APC mutation. The current literature and previously reported cases of hepatocellular carcinoma in patients with Gardner syndrome or familial adenomatous polyposis are reviewed. Conclusions Because hepatocellular carcinoma is uncommon in the pediatric and adolescent population, it is important to consider the possibility of Gardner syndrome or familial adenomatous polyposis in these patients.