Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial.

Importance: Inguinal hernia repair in preterm infants is common and is associated with considerable morbidity. Whether the inguinal hernia should be repaired prior to or after discharge from the neonatal intensive care unit is controversial. Objective: To evaluate the safety of early vs late surgical repair for preterm infants with an inguinal hernia. Design, Setting, and Participants: A multicenter randomized clinical trial including preterm infants with inguinal hernia diagnosed during initial hospitalization was conducted between September 2013 and April 2021 at 39 US hospitals. Follow-up was completed on January 3, 2023. Interventions: In the early repair strategy, infants underwent inguinal hernia repair before neonatal intensive care unit discharge. In the late repair strategy, hernia repair was planned after discharge from the neonatal intensive care unit and when the infants were older than 55 weeks' postmenstrual age. Main Outcomes and Measures: The primary outcome was occurrence of any prespecified serious adverse event during the 10-month observation period (determined by a blinded adjudication committee). The secondary outcomes included the total number of days in the hospital during the 10-month observation period. Results: Among the 338 randomized infants (172 in the early repair group and 166 in the late repair group), 320 underwent operative repair (86% were male; 2% were Asian, 30% were Black, 16% were Hispanic, 59% were White, and race and ethnicity were unknown in 9% and 4%, respectively; the mean gestational age at birth was 26.6 weeks [SD, 2.8 weeks]; the mean postnatal age at enrollment was 12 weeks [SD, 5 weeks]). Among 308 infants (91%) with complete data (159 in the early repair group and 149 in the late repair group), 44 (28%) in the early repair group vs 27 (18%) in the late repair group had at least 1 serious adverse event (risk difference, -7.9% [95% credible interval, -16.9% to 0%]; 97% bayesian posterior probability of benefit with late repair). The median number of days in the hospital during the 10-month observation period was 19.0 days (IQR, 9.8 to 35.0 days) in the early repair group vs 16.0 days (IQR, 7.0 to 38.0 days) in the late repair group (82% posterior probability of benefit with late repair). In the prespecified subgroup analyses, the probability that late repair reduced the number of infants with at least 1 serious adverse event was higher in infants with a gestational age younger than 28 weeks and in those with bronchopulmonary dysplasia (99% probability of benefit in each subgroup). Conclusions and Relevance: Among preterm infants with inguinal hernia, the late repair strategy resulted in fewer infants having at least 1 serious adverse event. These findings support delaying inguinal hernia repair until after initial discharge from the neonatal intensive care unit. Trial Registration: ClinicalTrials.gov Identifier: NCT01678638.

Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics: A Secondary Analysis of the CODA Randomized Clinical Trial.

Importance: Spanish-speaking participants are underrepresented in clinical trials, limiting study generalizability and contributing to ongoing health inequity. The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial intentionally included Spanish-speaking participants. Objective: To describe trial participation and compare clinical and patient-reported outcomes among Spanish-speaking and English-speaking participants with acute appendicitis randomized to antibiotics. Design, Setting, and Participants: This study is a secondary analysis of the CODA trial, a pragmatic randomized trial comparing antibiotic therapy with appendectomy in adult patients with imaging-confirmed appendicitis enrolled at 25 centers across the US from May 1, 2016, to February 28, 2020. The trial was conducted in English and Spanish. All 776 participants randomized to antibiotics are included in this analysis. The data were analyzed from November 15, 2021, through August 24, 2022. Intervention: Randomization to a 10-day course of antibiotics or appendectomy. Main Outcomes and Measures: Trial participation, European Quality of Life-5 Dimensions (EQ-5D) questionnaire scores (higher scores indicating a better health status), rate of appendectomy, treatment satisfaction, decisional regret, and days of work missed. Outcomes are also reported for a subset of participants that were recruited from the 5 sites with a large proportion of Spanish-speaking participants. Results: Among eligible patients 476 of 1050 Spanish speakers (45%) and 1076 of 3982 of English speakers (27%) consented, comprising the 1552 participants who underwent 1:1 randomization (mean age, 38.0 years; 976 male [63%]). Of the 776 participants randomized to antibiotics, 238 were Spanish speaking (31%). Among Spanish speakers randomized to antibiotics, the rate of appendectomy was 22% (95% CI, 17%-28%) at 30 days and 45% (95% CI, 38%-52%) at 1 year, while in English speakers, these rates were 20% (95% CI, 16%-23%) at 30 days and 42% (95% CI 38%-47%) at 1 year. Mean EQ-5D scores were 0.93 (95% CI, 0.92-0.95) among Spanish speakers and 0.92 (95% CI, 0.91-0.93) among English speakers. Symptom resolution at 30 days was reported by 68% (95% CI, 61%-74%) of Spanish speakers and 69% (95% CI, 64%-73%) of English speakers. Spanish speakers missed 6.69 (95% CI, 5.51-7.87) days of work on average, while English speakers missed 3.76 (95% CI, 3.20-4.32) days. Presentation to the emergency department or urgent care, hospitalization, treatment dissatisfaction, and decisional regret were low for both groups. Conclusions and Relevance: A high proportion of Spanish speakers participated in the CODA trial. Clinical and most patient-reported outcomes were similar for English- and Spanish-speaking participants treated with antibiotics. Spanish speakers reported more days of missed work. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Gastroschisis in Mozambique: current status and priorities for improving care from Hospital Central de Maputo, the largest and referral hospital of the country.

PURPOSE: Historically, gastroschisis was considered a death sentence in Mozambique. The purpose of this study was to evaluate the current state of gastroschisis management and outcomes in our facility and to identify potential areas of improvement in neonatal and surgical care. METHODS: A retrospective study was performed of all gastroschisis patients admitted to Hospital Central Maputo located in Maputo City/ Mozambique from 2019 to 2020. Demographic, perinatal, operative, and mortality data were obtained from neonatal and surgical logbooks. Descriptive analysis was performed. RESULTS: A total of 62 gastroschisis patients were admitted to the Hospital Central Maputo. No patients had a prenatal diagnosis. Many of the infants were born preterm (48%), and 68% had low birth weight. Only 15 (24%) patients underwent operative intervention (73% primary fascial closure and 27% sutured silo). There were only three survivors (5%) all of whom underwent primary closure. However, the overall survival rate for patients undergoing an attempt at surgical closure was 20%. CONCLUSION: While the mortality rate remains high for gastroschisis patients in Mozambique, there have been a few survivors when surgery is performed. Improvements in neonatal care are needed. Given the high mortality rates and limited resources, we plan to focus our surgical efforts on bedside closure techniques.

Multicenter Assessment of Cryoanalgesia Use in Minimally Invasive Repair of Pectus Excavatum: A 20-center Retrospective Cohort Study.

OBJECTIVE: To assess the clinical implications of cryoanalgesia for pain management in children undergoing minimally invasive repair of pectus excavatum (MIRPE). BACKGROUND: MIRPE entails significant pain management challenges, often requiring high postoperative opioid use. Cryoanalgesia, which blocks pain signals by temporarily ablating intercostal nerves, has been recently utilized as an analgesic adjunct. We hypothesized that the use of cryoanalgesia during MIRPE would decrease postoperative opioid use and length of stay (LOS). MATERIALS AND METHODS: A multicenter retrospective cohort study of 20 US children's hospitals was conducted of children (age below 18 years) undergoing MIRPE from January 1, 2014, to August 1, 2019. Differences in total postoperative, inpatient, oral morphine equivalents per kilogram, and 30-day LOS between patients who received cryoanalgesia versus those who did not were assessed using bivariate and multivariable analysis. P value <0.05 is considered significant. RESULTS: Of 898 patients, 136 (15%) received cryoanalgesia. Groups were similar by age, sex, body mass index, comorbidities, and Haller index. Receipt of cryoanalgesia was associated with lower oral morphine equivalents per kilogram (risk ratio=0.43, 95% confidence interval: 0.33-0.57) and a shorter LOS (risk ratio=0.66, 95% confidence interval: 0.50-0.87). Complications were similar between groups (29.8% vs 22.1, P =0.07), including a similar rate of emergency department visit, readmission, and/or reoperation. CONCLUSIONS: Use of cryoanalgesia during MIRPE appears to be effective in lowering postoperative opioid requirements and LOS without increasing complication rates. With the exception of preoperative gabapentin, other adjuncts appear to increase and/or be ineffective at reducing opioid utilization. Cryoanalgesia should be considered for patients undergoing this surgery.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

Assessment of an Opioid Stewardship Program on Perioperative Opioid Prescribing in a Safety-Net Health System.

This quality improvement study involves comparison of opioid prescription data before and after implementation of an opioid stewardship program in a safety-net medical system.

Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial.

Importance: A patient's belief in the likely success of a treatment may influence outcomes, but this has been understudied in surgical trials. Objective: To examine the association between patients' baseline beliefs about the likelihood of treatment success with outcomes of antibiotics for appendicitis in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial. Design, Setting, and Participants: This was a secondary analysis of the CODA randomized clinical trial. Participants from 25 US medical centers were enrolled between May 3, 2016, and February 5, 2020. Included in the analysis were participants with appendicitis who were randomly assigned to receive antibiotics in the CODA trial. After informed consent but before randomization, participants who were assigned to receive antibiotics responded to a baseline survey including a question about how successful they believed antibiotics could be in treating their appendicitis. Interventions: Participants were categorized based on baseline survey responses into 1 of 3 belief groups: unsuccessful/unsure, intermediate, and completely successful. Main Outcomes and Measures: Three outcomes were assigned at 30 days: (1) appendectomy, (2) high decisional regret or dissatisfaction with treatment, and (3) persistent signs and symptoms (abdominal pain, tenderness, fever, or chills). Outcomes were compared across groups using adjusted risk differences (aRDs), with propensity score adjustment for sociodemographic and clinical factors. Results: Of the 776 study participants who were assigned antibiotic treatment in CODA, a total of 425 (mean [SD] age, 38.5 [13.6] years; 277 male [65%]) completed the baseline belief survey before knowing their treatment assignment. Baseline beliefs were as follows: 22% of participants (92 of 415) had an unsuccessful/unsure response, 51% (212 of 415) had an intermediate response, and 27% (111 of 415) had a completely successful response. Compared with the unsuccessful/unsure group, those who believed antibiotics could be completely successful had a 13-percentage point lower risk of appendectomy (aRD, -13.49; 95% CI, -24.57 to -2.40). The aRD between those with intermediate vs unsuccessful/unsure beliefs was -5.68 (95% CI, -16.57 to 5.20). Compared with the unsuccessful/unsure group, those with intermediate beliefs had a lower risk of persistent signs and symptoms (aRD, -15.72; 95% CI, -29.71 to -1.72), with directionally similar results for the completely successful group (aRD, -15.14; 95% CI, -30.56 to 0.28). Conclusions and Relevance: Positive patient beliefs about the likely success of antibiotics for appendicitis were associated with a lower risk of appendectomy and with resolution of signs and symptoms by 30 days. Pathways relating beliefs to outcomes and the potential modifiability of beliefs to improve outcomes merit further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Hospital Variation in Surgical Technique for Repair of Uncomplicated Gastroschisis.

Practices in surgical repair of uncomplicated gastroschisis are varied. Data regarding hospital volume, surgical technique, clinical outcomes, and costs remain limited. Neonatal patients with uncomplicated gastroschisis were identified using the 2015-2019 National Readmissions Database. Hospital volume tertiles were determined, and sutureless or fascial repair techniques were enumerated. High volume centers (HVC) comprised the top tertile. Hospital-level variability in surgical technique was determined. Adjusted multivariable analysis was performed to compare clinical outcomes and costs among HVC and lower-volume centers and among repair techniques. Of an estimated 2903 hospitalizations meeting inclusion criteria, 23.5% occurred at HVC. There was 42.4% variation among sutureless and fascial repair techniques across all hospitals. Among HVC and lower-volume centers, there were no significant differences in rates of 30-day readmission or complication; however, HVC were associated with greater cost and length of stay. Those with codes for fascial repair technique experienced greater lengths of stay, costs, and rates of complication. Codes for surgical repair technique for uncomplicated gastroschisis vary widely, while outcomes are equivalent across strata of hospital volume. Those with codes for sutureless technique were associated with favorable clinical outcomes, irrespective of hospital volume. Guidelines for management of uncomplicated gastroschisis should account for hospital volume, variation in technique, outcomes, and resource utilization.

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.

IMPORTANCE: Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making. OBJECTIVE: To assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021. EXPOSURES: Appendectomy vs antibiotics. MAIN OUTCOMES AND MEASURES: Conditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons. RESULTS: Of 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91). CONCLUSIONS AND RELEVANCE: This cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.

Optimizing pediatric histrelin implantation to improve success rates in clinic without sedation.

OBJECTIVES: The purpose of this study was to review our success rate performing the histrelin implant procedure in clinic without sedation. METHODS: A retrospective study was performed for histrelin implant procedures done at our institution from 2008 to 2020. Wilcoxon rank-sum test or Fisher's exact test was utilized to identify significant differences (p<0.05). RESULTS: A total of 73 patients underwent 184 histrelin implant procedures from 2008 to 2020. In the past few years, there has been a decrease in procedures for precocious puberty and an increase for gender dysphoria. The majority of procedures were performed in clinic without sedation (82%). The only risk factor associated with requiring sedation was younger age (median 9 vs. 10 years; p<0.003). Complications (i.e. implant fracture or need for counter-incision) were noted in 10 of the procedures (5%). The only risk factor identified for a procedural complication during implant removal/replacement was interval time from insertion (21 vs. 13 months; p<0.01). The only documented wound problem reported was dermatitis in 1 patient (no suture granuloma, dehiscence, or implant extravasation). CONCLUSIONS: Procedural refinements and distraction therapy have enabled us to perform the majority of procedures in clinic without sedation. In our experience, procedural difficulty and complications appear to increase with prolonged implant duration. Histrelin implantation is increasingly being performed for gender dysphoria.

The first six years of the APSA Travel Fellowship Program: Impact and lessons learned.

INTRODUCTION: The American Pediatric Surgical Association (APSA) travel fellowship was established in 2013 to allow pediatric surgeons from low- and middle-income countries to attend the APSA annual meeting. Travel fellows also participated in various clinical and didactic learning experiences during their stay in North America. METHODS: Previous travel fellows completed a survey regarding their motivations for participation in the program, its impact on their practice in their home countries, and suggestions for improvement of the fellowship. RESULTS: Eleven surgeons participated in the travel fellowship and attended the annual APSA meetings in 2013-2018. The response rate for survey completion was 100%. Fellows originated from 9 countries and 3 continents and most fellows worked in government practice (n=8, 73%). Nine fellows (82%) spent >3 weeks participating in additional learning activities such as courses and clinical observerships. The most common reasons for participation were networking (n=11, 100%), learning different ways of providing care (n=10, 90.9%), new procedural techniques (n=9, 81.8%), exposure to a different medical culture (n=10, 90.9%), and engaging in research (n=8, 72.7%). Most of the fellows participated in a structured course: colorectal (n= 6, 55%), laparoscopy (n=2, 18%), oncology (n=2, 18%), leadership skills (n=1, 9%), and safety and quality initiatives (n=1, 9%). Many fellows participated in focused clinical mentorships: general pediatric surgery (n=9, 82%), oncology (n=5, 45%), colorectal (n=3, 27%), neonatal care (n=2, 18%) and laparoscopy (n=2, 18%). Upon return to their countries, fellows reported that they were able to improve a system within their hospital (n=7, 63%), expand their research efforts (n=6, 54%), or implement a quality improvement initiative (n=6, 54%). CONCLUSIONS: The APSA travel fellowship is a valuable resource for pediatric surgeons in low- and middle-income countries. After completion of these travel fellowships, the majority of these fellows have implemented important changes in their hospital's health systems, including research and quality initiatives, to improve pediatric surgical care in their home countries. LEVEL OF EVIDENCE: This is not a clinical study. Therefore, the table that lists levels of evidence for "treatment study", "prognosis study", "study of diagnostic test" and "cost effectiveness study" does not apply to this paper.

A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

Adherence to and outcomes of a University-Consortium gastroschisis pathway.

BACKGROUND: Our multi-institutional university consortium implemented a gastroschisis pathway in 2015 to standardize and improve care by promoting avoidance of routine intubation and paralysis during silo placement, expeditious abdominal wall closure, discontinuation of antibiotics/narcotics within 48 h of closure, and early initiation/advancement of feeds. METHODS: Adherence to the gastroschisis pathway was prospectively monitored. Outcomes for the contemporary cohort (2015-2018) were compared with a historical cohort (2007-2012). RESULTS: Good adherence to the pathway was observed for 70 cases of inborn uncomplicated gastroschisis. The contemporary cohort had significantly lower median mechanical ventilator days (2 versus 5; p < 0.01) and antibiotic days (5.5 versus 9; p < 0.01) as well as earlier days to initiation of feeds (12 versus 15; p < 0.01). However, no differences were observed in length of stay (28 versus 29 days; p = 0.70). A skin closure technique was performed in 66% of the patients, of which 46% were performed at bedside without intubation, the assistance of an operating-room team, or general anesthesia. CONCLUSION: In this study, adherence to a clinical pathway for gastroschisis across different facilities was feasible and led to reduction in exposure to mechanical ventilation and antibiotics. The adoption of a bedside skin closure technique appears to facilitate compliance with the pathway. LEVEL OF EVIDENCE: Level II/III TYPE OF STUDY: Prospective comparative study with historical cohort.

In utero ileal volvulus and intestinal perforation associated with enteric duplication cyst presenting with preterm labour and acute abdomen in newborn.

Enteric duplication cysts are a rare cause of intestinal obstruction in the neonatal period. We present the unusual case of an in utero ileal volvulus secondary to an enteric duplication cyst causing an acute abdomen in a 35-week estimated gestational age newborn female delivered to a mother in preterm labour.

Reduction in Prescribed Opioids after General Surgery Procedures at a Public Hospital.

Overdose of opioids is the number one cause of accidental death in the United States, and surgeons are overprescribing these medications. The aim of this study was to assess the feasibility of implementing postoperative opioid prescribing guidelines for general surgery procedures at a public hospital, where patients have lower socioeconomic status, public insurance, and limited access to care. We implemented a quality improvement project, which included in-service training for surgical staff and distribution of standardized guidelines. An infographic for patients was created to facilitate education on postoperative pain management. Pre- and postintervention opioid prescriptions and emergency room visits were compared for patients undergoing common general surgery procedures (inguinal hernia repair, appendectomy, and laparoscopic cholecystectomy). The median number of narcotic pills prescribed significantly decreased from 30 (n = 64) to 15 (n = 63) after the intervention (P < 0.0001). Morphine milligram equivalents decreased from a median [range] of 150 [20,600] to 90 [5,300] (P < 0.0001). The percentage of patients with postoperative pain-related emergency department visits remained low (1.6%). Standardization of postoperative opioid prescription practices was successfully implemented at a public hospital without an increase in the number of emergency room visits for pain.

Outcomes and costs of pediatric appendectomies at rural hospitals.

BACKGROUND/PURPOSE: Despite policy efforts to support rural hospitals, little is known about the quality and safety of pediatric surgical care in geographically remote areas. Our aim was to determine the outcomes and costs of appendectomies at rural hospitals. METHODS: The Kids' Inpatient Database (2003-2012) was queried for appendectomies in children <18 years at urban and rural hospitals. Outcomes (disease severity, laparoscopy, complications, length of stay (LOS), cost) were analyzed with bivariate and multivariable regression analysis. RESULTS: Rural hospitals performed 13.6% of appendectomies. On multivariable analysis, rural hospitals were associated with higher negative appendectomy rates (OR 1.49, 95% CI 1.39-1.60, p < 0.001), decreased appendiceal perforation rates (OR 0.86, 95% CI 0.83-0.89, p < 0.001), less laparoscopy use (OR 0.48, 95% CI 0.47-0.50, p < 0.001), higher complication rates (OR 1.29, 95% CI 1.19-1.39, p < 0.001), shorter LOS (IRR 0.90, 95% CI 0.89-0.91, p < 0.001), and slightly increased costs (exponentiated log$ 1.02, 95% CI 1.01-1.02, p < 0.001) CONCLUSIONS: Rural hospitals care for fewer patients with advanced appendicitis but are associated with higher negative appendectomy rates, lower laparoscopy use, and higher complication rates. Additional studies are needed to identify factors that drive this disparity to improve the quality of pediatric surgical care in rural settings. TYPE OF STUDY: Treatment/Cost Study (Outcomes). LEVEL OF EVIDENCE: Level III.

Methods of conservative antibiotic treatment of acute uncomplicated appendicitis: A systematic review.

BACKGROUND: Meta-analyses and a recent guideline acknowledge that conservative management of uncomplicated appendicitis with antibiotics can be successful for patients who wish to avoid surgery. However, guidance as to specific management does not exist. METHODS: PUBMED and EMBASE search of trials describing methods of conservative treatment was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. RESULTS: Thirty-four studies involving 2,944 antibiotic-treated participants were identified. The greatest experience with conservative treatment is in persons 5 to 50 years of age. In most trials, imaging was used to confirm localized appendicitis without evidence of abscess, phlegmon, or tumor. Antibiotics regimens were generally consistent with intra-abdominal infection treatment guidelines and used for a total of 7 to 10 days. Approaches ranged from 3-day hospitalization on parenteral agents to same-day hospital or ED discharge of stable patients with outpatient oral antibiotics. Minimum time allowed before response was evaluated varied from 8 to 72 hours. Although pain was a common criterion for nonresponse and appendectomy, analgesic regimens were poorly described. Trials differed in use of other response indicators, that is, white blood cell count, C-reactive protein, and reimaging. Diet ranged from restriction for 48 hours to as tolerated. Initial response rates were generally greater than 90% and most participants improved by 24 to 48 hours, with no related severe sepsis or deaths. In most studies, appendectomy was recommended for recurrence; however, in several, patients had antibiotic retreatment with success. CONCLUSION: While further investigation of conservative treatment is ongoing, patients considering this approach should be advised and managed according to study methods and related guidelines to promote informed shared decision-making and optimize their chance of similar outcomes as described in published trials. Future studies that address biases associated with enrollment and response evaluation, employ best-practice pain control and antibiotic selection, better define cancer risk, and explore longer time thresholds for response, minimized diet restriction and hospital stays, and antibiotic re-treatment will further our understanding of the potential effectiveness of conservative management. LEVEL OF EVIDENCE: Systematic review, level II.

Current Challenges of Plastic Surgical Care in Sub-Saharan Africa (Maputo, Mozambique).

BACKGROUND: Limited data exist on plastic surgery practices in Sub-Saharan Africa. The aim of this study was to characterize the spectrum of disease and operative procedures at a teaching hospital in Maputo, Mozambique to help understand the challenges of providing care for the local providers and to provide contextual relevance for training through partnerships. METHODS: A mixed-methods approach was utilized to perform an ongoing needs assessment. A retrospective review was performed of plastic surgery operative records, ward admissions records, and death records in a tertiary-care hospital in Maputo, Mozambique for the period January 2015 to December 2015. RESULTS: Limited resources (equipment, block-time, personnel, and perioperative services) were observed. The most common diagnoses for the 455 patients evaluated were burns (44%) and neoplasms (17%). Congenital abnormalities accounted for only 1% of the patient diagnoses. Of the 408 procedures performed, the majority were skin grafts (43%) and skin excisions (31%). Sepsis from burns accounted for 70% of documented deaths (14/20). The mean number of days to skin grafting for inpatients was 53 days. CONCLUSION: We observed a large burden of burns and skin graft procedures at a public referral teaching hospital in Mozambique. Our findings provide contextual relevance to help focus public health efforts and improve plastic surgery training and practices.

Epidemiology of Disease and Mortality From a PICU in Mozambique.

OBJECTIVES: Delivery of pediatric critical care in low-income countries is limited by a lack of infrastructure, resources, and providers. Few studies have analyzed the epidemiology of disease associated with a PICU in a low-income country. The aim of this study was to document the primary diagnoses and the associated mortality rates of patients presenting to a tertiary PICU in Mozambique in order to formulate quality improvement projects through an international academic partnership. We hypothesized that the PICU mortality rate would be high and that sepsis would be a common cause of death. DESIGN: Retrospective, observational study. SETTING: Tertiary academic PICU. PATIENTS: All admitted PICU patients. INTERVENTIONS: All available data collection forms containing demographic and clinical data of patients admitted to the PICU at Hospital Central de Maputo, Mozambique from January 2013 to December 2013 were analyzed retrospectively. MEASUREMENTS AND MAIN RESULTS: The patient median age was 2 years (57% male). The most common primary diagnoses were malaria (22%), sepsis (18%), respiratory tract infections (12%), and trauma (6%). The mortality rate was 25%. Mortality rates were highest among patients with sepsis (59%), encephalopathy (56%), noninfectious CNS pathologies (33%), neoplastic diseases (33%), meningitis/encephalitis (29%), burns (26%), and cardiovascular pathologies (26%). The median length of PICU stay was 2 days. HIV exposure/infection had a nonstatistically significant association with mortality. Patients admitted for burns had the highest median length of PICU stay (4 d). Most trauma admissions were male (75%), and approximately half of all trauma admissions had an associated head injury (55%). CONCLUSIONS: Infectious disease and trauma were highly represented in this Mozambican PICU, and overall mortality was high compared with high-income countries. With this knowledge, targeted collaborative projects in Mozambique can now be created and modified. Further research is needed to monitor the potential benefits of such interventions.