Susan W. Sharp

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).

An evidence-based definition for perforated appendicitis derived from a prospective randomized trial

PURPOSE Appendicitis is the most common urgent condition in general surgery, and yet there is no evidence-based definition for perforation. Therefore, all retrospective data published on perforated appendicitis are unreliable because of an ill-defined denominator. For approximately 2 years beginning in April 2005, we performed a prospective randomized trial investigating 2 different antibiotic regimens for perforated appendicitis. During this study, we strictly defined perforation as a hole in the appendix or a fecalith in the abdomen. Before this prospective study, perforation was staff surgeon opinion. We investigated the abscess rates in both the perforated and nonperforated appendicitis populations before and during the study to determine if our definition was safe and that there was not an increased risk of abscess formation in patients treated as nonperforated. METHODS Records of all patients undergoing laparoscopic appendectomy for appendicitis during the immediate 2 years before using the definition were compared to those treated in the 2 years after the definition was implemented. Interval and incidental appendectomies were ruled out. The postoperative abscess rate (when perforation was not defined) was compared to the abscess rate of those for whom perforation was strictly defined. RESULTS There were 292 patients treated for acute nonperforated appendicitis in the 2 years before the definition and 388 patients after the definition. There were 131 patients treated for perforated appendicitis before the definition and 161 after the definition was implemented. The abscess rate in those with perforated appendicitis increased from 14% to 18% after the definition was used. However, after the definition began to be used, the abscess rate for those patients treated as nonperforated decreased from 1.7% to 0.8%. CONCLUSIONS Defining perforation as a hole in the appendix or a fecalith in the abdomen is effective in identifying the patients at risk for postoperative abscess formation. Application of these criteria would allow substantial reduction in therapy for patients with purulent or gangrenous appendicitis who do not possess the same abscess risk. These data outline the first evidence-based definition of perforation.

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.

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.

Irrigation versus suction alone during laparoscopic appendectomy for perforated appendicitis: A prospective randomized trial

Background:The efficacy of irrigating the peritoneal cavity during appendectomy for perforated appendicitis has been debated extensively. To date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing peritoneal irrigation to suction alone during laparoscopic appendectomy in children. Methods:Children younger than 18 years with perforated appendicitis were randomized to peritoneal irrigation with a minimum of 500 mL normal saline, or suction only during laparoscopic appendectomy. Perforation was defined as a hole in the appendix or fecalith in the abdomen. The primary outcome variable was postoperative abscess. Using a power of 0.8 and alpha of 0.05, a sample size of 220 patients was calculated. A battery-powered laparoscopic suction/irrigator was used in all cases. Pre- and postoperative management was controlled. Data were analyzed on an intention-to-treat basis. Results:A total of 220 patients were enrolled between December 2008 and July 2011. There were no differences in patient characteristics at presentation. There was no difference in abscess rate, which was 19.1% with suction only and 18.3% with irrigation (P = 1.0). Duration of hospitalization was 5.5 ± 3.0 with suction only and 5.4 ± 2.7 days with group (P = 0.93). Mean hospital charges was

Resource utilization and outcomes from percutaneous drainage and interval appendectomy for perforated appendicitis with abscess.

48.1K in both groups (P = 0.97). Mean operative time was 38.7 ± 14.9 minutes with suction only and 42.8 ± 16.7 minutes with irrigation (P = 0.056). Irrigation was felt to be necessary in one case (0.9%) randomized to suction only. In the patients who developed an abscess, there was no difference in duration of hospitalization, days of intravenous antibiotics, duration of home health care, or abscess-related charges. Conclusions:There is no advantage to irrigation of the peritoneal cavity over suction alone during laparoscopic appendectomy for perforated appendicitis. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).

Prospective validation of an abbreviated bedrest protocol in the management of blunt spleen and liver injury in children

OBJECTIVE Given the perceived technical demands of laparoscopic appendectomy and the expected postoperative morbidity in patients with a well-defined abscess, initial percutaneous drainage has become an attractive option in this patient population. This strategy allows for a laparoscopic appendectomy to be performed in an elective manner at the convenience of the surgeon. However, the medical burden on the patient and on the quality of patient outcomes has not been described in the literature. Therefore, we audited our experience with initial percutaneous drainage followed by laparoscopic interval appendectomy to evaluate the need for a prospective trial. METHODS After institutional review board approval, a retrospective chart review was performed on all children who presented with perforated appendicitis and a well-defined abscess and were treated by initial percutaneous aspiration/drainage followed by interval appendectomy between January 2000 and September 2006. Continuous variables are listed with standard deviation. RESULTS There were 52 patients with a mean age of 9.0 +/- 3.9 years and weight of 34.4 +/- 18.8 kg. The mean duration of symptoms at presentation was 8.4 +/- 7.6 days. Percutaneous aspiration only was performed in 2 patients. The mean volume of fluid on initial aspiration/drain placement was 76.3 +/- 81.1 mL. The mean time to appendectomy was 61.9 +/- 25.2 days. The laparoscopic approach was used in 49 patients (94.2%), of which one was converted to an open operation. The mean length of hospitalization after interval appendectomy was 1.4 +/- 1.4 days. A recurrent abscess developed in 17.3% of the patients. Six patients (11.5%) required another drainage procedure. The mean total charge to the patients was

Minimal vs extensive esophageal mobilization during laparoscopic fundoplication: a prospective randomized trial.

40,414.02. There were 4 significant drain complications (ileal perforation, colon perforation, bladder perforation, and buttock/thigh necrotizing abscess). The child with the ileal perforation after drain placement is the only patient who failed initial nonoperative therapy. CONCLUSIONS The use of initial percutaneous aspiration/drainage of periappendiceal abscess followed by interval appendectomy is an effective approach. However, this management poses complication risks and uses considerable resources. Therefore, this strategy should be compared with early operation in a prospective trial.