Ramesh M Nataraja1, Gayathri Panabokke2, Annette D Chang2, Nicole Mennie2, Sharman Tan Tanny2, Charles Keys2, Wei Cheng3, Maurizio Pacilli4, Peter Ferguson2. 1. Department of Paediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia. Electronic address: ram.nataraja@monashhealth.org. 2. Department of Paediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia. 3. Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Paediatric Surgery, Beijing United Family Hospital, Beijing, People's Republic of China. 4. Department of Paediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
Abstract
BACKGROUND: There is ongoing debate concerning the use of peritoneal irrigation in the setting of complicated appendicitis (CA) in children. Our aim was to conduct a prospective randomized controlled trial for the treatment of CA during a laparoscopic appendicectomy in children. METHODS: Following ethical approval (REC10138B), pediatric patients (≤16 years old) were recruited from a single institution over a 3-year time period (2015-2018). Randomization occurred following intraoperative diagnosis of CA to either peritoneal lavage (PL) or suction only (SO). Primary outcome was the length of stay (LoS), and secondary outcomes were the presence of a postoperative intraabdominal abscess (IAA), wound infection (WI), or adhesive small bowel obstruction (ASBO). Data are reported as number of cases (%), median (range), odds ratio [OR] and analyzed using t-test and Fisher's exact test. A p-value ≤0.05 was considered significant. RESULTS: A total of 100 pediatric patients were recruited into the trial. Sixteen were excluded owing to either recruitment or protocol violations, and therefore a total of 86 underwent final analysis: 44 PL and 42 SO. There was no significant difference in the LoS: 5.7 (PL) vs 5.6 (SO) days, p = 0.75. Only 1 IAA occurred in the PL group: 1/44(2.3%) vs 0/42(0%), p = 1.0. There was 1 ASBOs in the PL group (2.3%, p = 1.0) and no WIs in either of the groups. CONCLUSION: This prospective randomized control trial has revealed equivalence in techniques for the treatment of complicated appendicitis. It has also revealed a low complication rate following pediatric LA with either PL or SO. TYPE OF STUDY: Randomized controlled trial. LEVEL OF EVIDENCE: Level I.
RCT Entities:
BACKGROUND: There is ongoing debate concerning the use of peritoneal irrigation in the setting of complicated appendicitis (CA) in children. Our aim was to conduct a prospective randomized controlled trial for the treatment of CA during a laparoscopic appendicectomy in children. METHODS: Following ethical approval (REC10138B), pediatric patients (≤16 years old) were recruited from a single institution over a 3-year time period (2015-2018). Randomization occurred following intraoperative diagnosis of CA to either peritoneal lavage (PL) or suction only (SO). Primary outcome was the length of stay (LoS), and secondary outcomes were the presence of a postoperative intraabdominal abscess (IAA), wound infection (WI), or adhesive small bowel obstruction (ASBO). Data are reported as number of cases (%), median (range), odds ratio [OR] and analyzed using t-test and Fisher's exact test. A p-value ≤0.05 was considered significant. RESULTS: A total of 100 pediatric patients were recruited into the trial. Sixteen were excluded owing to either recruitment or protocol violations, and therefore a total of 86 underwent final analysis: 44 PL and 42 SO. There was no significant difference in the LoS: 5.7 (PL) vs 5.6 (SO) days, p = 0.75. Only 1 IAA occurred in the PL group: 1/44(2.3%) vs 0/42(0%), p = 1.0. There was 1 ASBOs in the PL group (2.3%, p = 1.0) and no WIs in either of the groups. CONCLUSION: This prospective randomized control trial has revealed equivalence in techniques for the treatment of complicated appendicitis. It has also revealed a low complication rate following pediatric LA with either PL or SO. TYPE OF STUDY: Randomized controlled trial. LEVEL OF EVIDENCE: Level I.