Pre-operative mechanical bowel preparation and prophylactic oral antibiotics for pediatric patients undergoing elective colorectal surgery: a protocol for a randomized controlled feasibility trial.

BACKGROUND: Infections after elective colorectal surgery remain a significant burden for patients and the healthcare system. Adult studies suggest that the combination of oral antibiotics and mechanical bowel preparation is effective at reducing infections after colorectal surgery. In children, there is limited evidence for either of these practices and the utility of combining oral antibiotics with mechanical bowel preparation remains uncertain. METHODS: This study aims to determine the feasibility of conducting a randomized controlled trial assessing the efficacy of oral antibiotics, with or without mechanical bowel preparation, in reducing the rates of post-operative infection in pediatric colorectal surgery. Participants aged 3 months to 18 years undergoing elective colorectal surgery will be randomized pre-operatively to one of three trial arms: (1) oral antibiotics; (2) oral antibiotics and mechanical bowel preparation; or (3) standard care. Twelve patients will be included in each trial arm. Feasibility outcomes of interest include the rate of participant recruitment, post-randomization exclusions, protocol deviations, adverse events, and missed follow-up appointments. Secondary outcomes include the rate of post-operative surgical site infections, length of hospital stay, time to full enteral feeds, reoperation, readmission, and complications. DISCUSSION: If the results of this trial prove feasible, a multi-center trial will be completed with sufficient power to evaluate the optimal pre-operative bowel preperation for pediatric patients undergoing elective colorectal surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03593252.

The fragility of statistically significant findings from randomized controlled trials in pediatric appendicitis: A systematic review.

PURPOSE: Randomized controlled trials (RCT) in pediatric appendicitis remain limited, and the robustness of available evidence is unknown. The aim of this study was to determine the fragility of results in pediatric appendicitis RCTs. METHODS: A systematic search of Embase and MEDLINE was performed. Eligible studies were two-armed RCTs that included at least one statistically significant dichotomous outcome, had parallel-group allocation, and assessed pediatric patients (0-17) with a primary diagnosis of appendicitis. The Fragility Index (FI) for one statistically significant outcome per trial was calculated using a Fisher's exact test, with statistical significance set at p < 0.05. RESULTS: Six studies were identified for inclusion. Studies included a median of 103 patients (interquartile range [IQR] 86-127), with a median of 18 (IQR 4.5-41.25) events for analyzed outcomes. The primary outcome variable was included in analysis for 4(67%) studies. The median FI across studies was 3 (IQR 0.75-4.25), with results ranging from 0 to 5. Results indicate that overall, converting 3 patients from non-events to events in a single trial arm would change the significant dichotomous outcome to nonsignificant. CONCLUSION: The fragility of results in RCTs in pediatric appendicitis should be considered before clinical practice is changed. Investigators should consider reporting the FI alongside study results, as p-values alone may be misleading. TYPE OF STUDY: Randomized Controlled Trial. LEVEL OF EVIDENCE: Level I.

Pathophysiology, prevention, treatment, and outcomes of intestinal failure-associated liver disease.

BACKGROUND: Intestinal failure-associated liver disease (IFALD) remains a serious problem in the treatment of infants with nutritional problems and short bowel syndrome. METHODS: A review of the recent literature from 2010 to 2016, concentrating on articles related to the pathophysiology of IFALD and to outcomes of novel nutritional and pharmacological therapies for neonatal cholestasis in the post-surgical neonate. RESULTS: The pathophysiology of IFALD relates to an increase sensitivity of the neonatal liver to cholestasis in the non-fed state; prolonged cholestasis almost inevitably results in liver damage which will progress from fibrosis to cirrhosis. Clinically discerned risk factors include premature birth, inflammation, sepsis, disruption of the enterohepatic circulation by creation of a proximal stoma, and the duration and type of parenteral nutritional support. Within the hepatocyte, the regulatory enzyme farsanoid receptor X (FXR) appears to play a pivotal role in the development of cholestasis. Recent studies have shown that its activity is suppressed by sepsis, and by plant phytosterols found in soy-based lipid preparations. This paradigm is reflected in the emerging consensus for the care of post-surgical neonates, which is based around a multi-disciplinary team approach. Using an algorithm-driven approach, an appropriate balance between caloric support and prevention of IFALD can be achieved. CONCLUSIONS: Further prospective studies are required to further refine the optimal sequence of use of these therapies and the long-term effects on neurological development and hepatic function. However, with optimal care, the number of IF patients progressing to end-stage liver disease because of IFALD should be very low.

Hamartoma of the urinary bladder in a 15-year-old boy.

Hamartoma of the bladder is an unusual entity described in only eleven patients to date. It may present as painless hematuria, irritative urinary tract symptoms, or inability to void or it may be diagnosed incidentally. Hamartoma of the bladder may be isolated or occur as part of a syndrome. No isolated bladder hamartoma to date has shown malignant potential. We describe here a bladder hamartoma in a 15-year-old boy.

Congenital duodenal obstruction associated with Down's syndrome presenting with hematemesis.

Congenital duodenal obstruction is usually characterized by onset of early vomiting due to high bowel obstruction. Presentation of congenital duodenal obstruction with acute gastrointestinal bleeding is very uncommon. We present an unusual case of congenital intrinsic duodenal obstruction associated with the Down's syndrome presenting with hematemesis secondary to duodenitis. This is a rare presentation of congenital duodenal obstruction associated with Down's syndrome in addition to seven cases previously reported in the English literature.

Role of ultrasonography in the preoperative assessment of impalpable testes: a single center experience.

Background. Abdominoscrotal sonogram is often used in boys with a nonpalpable testis to determine the presence of the testis. We describe our experience with the use of ultrasonography in boys with a nonpalpable testis. Methods. We retrospectively reviewed the medical records of boys aged less than 14 years, who underwent preoperative ultrasonography for an impalpable undescended testis (IUDT) between 2006 and 2010 in our institution. The results of sonography and laparoscopy were compared. Results. A total of 26 impalpable testes in 22 patients, including 4 with bilateral impalpable testes, were preoperatively assessed by ultrasonography for their localization. Sonography localized only 6 of the 26 (23%) testes, which were laparoscopically explored and followed by orchiopexy. Conclusion. Ultrasound is not reliable in the preoperative assessment of patients with impalpable testes.