RESUMEN
OBJECTIVE: To develop an international core outcome set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating treatments of acute simple appendicitis in children. SUMMARY OF BACKGROUND DATA: A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS. METHODS: The development process consisted of 4 phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a 2-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS. RESULTS: The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (8 countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with 10 outcomes emerging with consensus. After 2 young peoples' focus groups, 2 additional outcomes were added to the final COS (12): mortality, bowel obstruction, intraabdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications. CONCLUSION: An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment ofsimple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.
Asunto(s)
Apendicitis , Niño , Humanos , Adolescente , Técnica Delphi , Apendicitis/cirugía , Proyectos de Investigación , Consenso , Enfermedad Aguda , Evaluación de Resultado en la Atención de Salud/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Necrotizing enterocolitis has a wide clinical spectrum of manifestation. We report a novel method of managing focal isolated perforation in necrotizing enterocolitis by using diagnostic laparoscopy to localize the site of perforation and by making a microincision over the perforation to perform exteriorization or limited resection and primary anastomosis. METHODS: We included low-birth weight infants presenting with sudden clinical deterioration and pneumoperitoneum. Patients with gross abdominal wall signs were excluded on the probability that they had extensive disease. Diagnostic laparoscopy was performed using a 3.5-mm trocar and 1.9-mm telescope. A 1-cm incision was made over the site of perforation, and local surgical debridement was performed. RESULTS: There were 3 extremely low-birth weight patients (580, 700, and 780 g) and 1 larger infant (1.6 kg). In all cases, an isolated perforation was detected. None had widespread disease. The 3 smaller infants had exteriorization and enterostomies. The larger patient had resection and primary anastomosis. All patients recovered uneventfully. CONCLUSION: Diagnostic laparoscopy can be safely performed in extremely low-birth weight infants. It allows precise identification of the site of perforation to perform a limited microlaparotomy at this site, significantly reducing the surgical trauma of extensive bowel handling. We report a novel method of managing this vexing problem.