Abstract
Background/Aim
Paediatric surgical practice should be based upon solid scientific evidence. A study in 1998 (Baraldini et al., Pediatr Surg Int) indicated that only a quarter of paediatric operations were supported by the then gold standard of evidence based medicine (EBM) which was defined by randomized controlled trials (RCTs). The aim of the current study was to re-evaluate paediatric surgical practice 16 years after the previous study in a larger cohort of patients.
Methods
A prospective observational study was performed in a tertiary level teaching hospital for children. The study was approved by the local research ethics board. All diagnostic and therapeutic procedures requiring a general anaesthetic carried out over a 4-week period (24 Feb 2014–22 Mar 2014) under the general surgery service or involving a general paediatric surgeon were included in the study. Pubmed and EMBASE were used to search in the literature for the highest level of evidence supporting the recorded procedures. Evidence was classified according to the Oxford Centre for Evidence Based Medicine (OCEBM) 2009 system as well as according to the classification used by Baraldini et al. Results was compared using Χ 2 test. P < 0.05 was considered statistically significant.
Results
During the study period, 126 operations (36 different types) were performed on 118 patients. According to the OCEBM classification, 62 procedures (49 %) were supported by systematic reviews of multiple homogeneous RCTs (level 1a), 13 (10 %) by individual RCTs (level 1b), 5 (4 %) by systematic reviews of cohort studies (level 2a), 11 (9 %) by individual cohort studies, 1 (1 %) by systematic review of case–control studies (level 3a), 14 (11 %) by case–control studies (level 3b), 9 (7 %) by case series (type 4) and 11 procedures (9 %) were based on expert opinion or deemed self-evident interventions (type 5). High level of evidence (OCEBM level 1a or 1b or level I according to Baraldini et al. PSI 1998) supported 75 (60 %) operations in the current study compared to 18 (26 %) in the study of 1998 (P < 0.0001).
Conclusion
The present study shows that nowadays a remarkable number of paediatric surgical procedures are supported by high level of evidence. Despite this improvement in evidence-based paediatric surgical practice, more than a third of the procedures still lack sufficient evidence-based literature support. More RCTs are warranted to support and direct paediatric surgery practice according to the principals of EBM.
Similar content being viewed by others
References
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996) Evidence based medicine: what it is and what it isn’t. BMJ 13:71–72
Baraldini V, Spitz L, Pierro A (1998) Evidence-based operations in paediatric surgery. Pediatr Surg Int 13:331–335
Hardin WD Jr, Stylianos S, Lally KP (1999) Evidence-based practice in pediatric surgery. J Pediatr Surg 34:908–912
Ostlie DJ, St Peter SD (2010) The current state of evidence-based pediatric surgery. J Pediatr Surg 45:1940–1946
Dingemann J, Ure BM (2013) Systematic review of level 1 evidence for laparoscopic pediatric surgery: do our procedures comply with the requirements of evidence-based medicine? Eur J Pediatr Surg 23:474–479
OCEBM Levels of Evidence Working Group. Levels of Evidence (March 2009). Oxford Centre for Evidence-Based Medicine. Available at: http://www.cebm.net/index.aspx?o¼1025
Xu AM, Huang L, Li TJ (2014) Single-incision versus three-port laparoscopic appendectomy for acute appendicitis: systematic review and meta-analysis of randomized controlled trials. Surg Endosc. [Epub ahead of print] PubMed PMID: 25106718
Svensson JF, Patkova B, Almström M, et al (2014) Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. [Epub ahead of print] PubMed PMID: 25072441
Liu ZH, Li C, Zhang XW, Kang L et al (2014) Meta-analysis of the therapeutic effects of antibiotic versus appendicectomy for the treatment of acute appendicitis. Exp Ther Med 7:1181–1186
Yang C, Zhang H, Pu J et al (2011) Laparoscopic vs open herniorrhaphy in the management of pediatric inguinal hernia: a systemic review and meta-analysis. J Pediatr Surg 46:1824–1834
Alzahem A (2011) Laparoscopic versus open inguinal herniotomy in infants and children: a meta-analysis. Pediatr Surg Int 27:605–612
Jia WQ, Tian JH, Yang KH et al (2011) Open versus laparoscopic pyloromyotomy for pyloric stenosis: a meta-analysis of randomized controlled trials. Eur J Pediatr Surg 21:77–81
Sola JE, Neville HL (2009) Laparoscopic vs open pyloromyotomy: a systematic review and meta-analysis. J Pediatr Surg 44:1631–1637
St Peter SD, Holcomb GW III, Calkins CM et al (2006) Open versus laparoscopic pyloromyotomy for pyloric stenosis: a prospective, randomized trial. Ann Surg 244:363–370
Friedrich JO, Adhikari NK, Beyene J (2007) Inclusion of zero total event trials in meta-analyses maintains analytic consistency and incorporates all available data. BMC Med Res Methodol 7:5
Greason KL, Allshouse MJ, Thompson WR et al (1997) A prospective, randomized evaluation of laparoscopic versus open pyloromyotomy in the treatment of infantile hypertrophic pyloric stenosis. Pediatri Endosurg Innov Tech 1:175–179
St. Peter SD, Holcomb GW III, Calkins CM et al (2006) Open versus laparoscopic pyloromyotomy for pyloric stenosis: a prospective, randomized trial. Ann Surg 244:363–370
Leclair MD, Plattner V, Mirallie E et al (2007) Laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: a prospective, randomized controlled trial. J Pediatr Surg 42:692–698
Hall NJ, Pacilli M, Eaton S et al (2009) Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial. Lancet 373:390–398
Raval MV, Hall NJ, Pierro A, Moss RL (2013) Evidence-based prevention and surgical treatment of necrotizing enterocolitis—a review of randomized controlled trials. Semin Pediatr Surg 22:117–121
Bohnhorst B, Muller S, Dordelmann M et al (2003) Early feeding after necrotizing enterocolitis in preterm infants. J Pediatr 143:484–487
Moss RL, Dimmitt RA, Barnhart DC et al (2006) Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med 354:2225–2234
Rees CM, Eaton S, Kiely EM et al (2008) Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial. Ann Surg 248:44–51
Shehata SM (2009) Prospective long-term functional and cosmetic results of ASARP versus PASRP in treatment of intermediate anorectal malformations in girls. Pediatr Surg Int 25:863–868
Bucher P, Pugin F, Buchs NC et al (2011) Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg 98:1695–1702
Rosenmuller MH, Thoren Ornberg M, Myrnas T et al (2013) Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy. Br J Surg 100:886–894
Abolyosr A (2006) Laproscopic versus open orchidopexy in the management of abdominal testis; a descriptive study. Int J Urol 13:1421–1424
Kollin C, Karpe B, Hesser U et al (2007) Surgical treatment of unilaterally undescended testes: testicular growth after randomization to orchiopexy at age 9 months or 3 years. J Urol 178:1589–1593
Guo J, Liang Z, Zhang H et al (2011) Laparoscopic versus open orchiopexy for non-palpable undescended testes in children: a systemic review and meta-analysis. Pediatr Surg Int 27:943–952
Ferro F, Spagnoli A, Zaccara A et al (1999) Is preoperative laparoscopy useful for impalpable testis? J Urol 162:995–996
Lansdale N, Alam S, Losty PD et al (2010) Neonatal endosurgical congenital diaphragmatic hernia repair: a systematic review and meta-analysis. Ann Surg 252:20–26
Moyer V, Moya F, Tibboel R, et al (2002). Late versus early surgical correction for congenital diaphragmatic hernia in newborn infants. Cochrane Database Syst Rev:CD001695
Keller RL, Hawgood S, Neuhaus JM et al (2004) Infant pulmonary function in a randomized trial of fetal tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Res 56:818–825
De La Hunt MN, Madden N, Scott JES et al (1996) Is delayed surgery really better for congenital diaphragmatic hernia? A prospective randomized clinical trial. J Pediatr Surg 31:1554–1556
Harrison MR, Albanese CT, Hawgood SB et al (2001) Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol 185:730–733
Harrison MR, Sydorak RM, Farrell JA et al (2003) Fetoscopic temporary tracheal occlusion for congenital diaphragmatic hernia: prelude to a randomized, controlled trial. J Pediatr Surg 38:1012–1020
Harrison MR, Langer JC, Adzick NS et al (1990) Correction of congenital diaphragmatic hernia in utero, V. Initial clinical experience. J Pediatr Surg 25:47–55
Harrison MR, Adzick NS, Flake AW et al (1993) Correction of congenital diaphragmatic hernia in utero: VI. Hard-earned lessons. J Pediatr Surg 28:1411–1417
Harrison MR, Keller RL, Hawgood SB et al (2003) A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med 349:1916–1924
Randomized control trial of fetoscopic endoluminal tracheal occlusion with a balloon versus expectant management during pregnancy in fetuses with left sided congenital diaphragmatic hernia and moderate pulmonary hypoplasia. (TOTAL). http://clinicaltrials.gov/ct2/show/NCT00763737
Ponten JE, Leenders BJ, Charbon JA et al (2014) Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial. BMC Surg 14:33
Bensaadi H, Paolino L, Valenti A et al (2014) Intraperitoneal tension-free repair of a small midline ventral abdominal wall hernia: randomized study with a mean follow-up of 3 years. Am Surg 80:57–65
Bishay M, Giacomello L, Retrosi G et al (2013) Hypercapnia and acidosis during open and thoracoscopic repair of congenital diaphragmatic hernia and esophageal atresia: results of a pilot randomized controlled trial. Ann Surg 258:895–900
Buskens CJ, Sahami S, Tanis PJ et al (2014) The potential benefits and disadvantages of laparoscopic surgery for ulcerative colitis: a review of current evidence. Best Pract Res Clin Gastroenterol 28:19–27
Polle SW, Dunker MS, Slors JF et al (2007) Body image, cosmesis, quality of life, and functional outcome of hand-assisted laparoscopic versus open restorative proctocolectomy: long-term results of a randomized trial. Surg Endosc 21:1301–1307
Hall NJ, Ron O, Eaton S et al (2011) Surgery for hydrocele in children-an avoidable excess? J Pediatr Surg 46:2401–2405
Chen Z, Amos EB, Luo H et al (2012) Comparative pulmonary functional recovery after Nuss and Ravitch procedures for pectus excavatum repair: a meta-analysis. J Cardiothorac Surg 7:101
Jayaramakrishnan K, Wotton R, Bradley A et al (2013) Does repair of pectus excavatum improve cardiopulmonary function? Interact CardioVasc Thorac Surg 16:865–870
Galluzzi F, Pignataro L, Gaini RM et al (2013) Risk of recurrence in children operated for thyroglossal duct cysts: a systematic review. J Pediat Surg 48:222–227
Batool T, Akhtar J, Ahmed S (2005) Management of idiopathic rectal prolapse in children. J Coll Physician Surg Pak 15:628–630
Christoffersen MW, Helgstrand F, Rosenberg J, et al (2014) Long-term recurrence and chronic pain after repair for small umbilical or epigastric hernias: a regional cohort study. Am J Surg. doi:10.1016/j.amjsurg.2014.05.021
Nakajima Y, Sakata H, Yamaguchi T et al (2013) Successful treatment of a 14-year-old patient with intestinal malrotation with laparoscopic Ladd procedure: case report and literature review. World J Emerg Surg 8:19
Sinha CK, Paramalingam S, Patel S et al (2009) Feasibility of complex minimally invasive surgery in neonates. Pediatr Surg Int 25:217–221
Hsiao M, Langer JC (2011) Value of laparoscopy in children with a suspected rotation abnormality on imaging. J Pediatr Surg 46:1347–1352
Spilde TL, St Peter SD, Keckler SJ et al (2008) Open vs laparoscopic repair of congenital duodenal obstructions: a concurrent series. J Pediatr Surg 43:1002–1005
Lee J, Tashjian DB, Moriarty KP (2012) Surgical management of pediatric adhesive bowel obstruction. J Laparoendosc Adv Surg Tech A 22:917–920
Nah SA, Narayanaswamy B, Eaton S et al (2010) Gastrostomy insertion in children: percutaneous endoscopic or percutaneous image-guided? J Pediatr Surg 45:1153–1158
Baker L, Emil S, Baird R (2013) A comparison of techniques for laparoscopic gastrostomy placement in children. J Surg Res 184:392–396
Liu R, Jiwane A, Varjavandi A et al (2013) Comparison of percutaneous endoscopic, laparoscopic and open gastrostomy insertion in children. Pediatr Surg Int 29:613–621
Malek MM, Mollen KP, Kane TD et al (2010) Thoracic neuroblastoma: a retrospective review of our institutional experience with comparison of the thoracoscopic and open approaches to resection. J Pediatr Surg 45:1622–1626
Petty JK, Bensard DD, Partrick DA et al (2006) Resection of neurogenic tumors in children: is thoracoscopic superior to thoracotomy? J Am Coll Surg 203:699–703
Soyer T, Karnak I, Ciftci AO et al (2006) The results of surgical treatment of chest wall tumors in childhood. Pediatr Surg Int 22:135–139
Masuko T, Uchida H, Kawashima H et al (2013) Laparoscopic excision of urachal remnants is a safe and effective alternative to open surgery in children. J Laparoendosc Adv Surg Tech 23:1016–1019
Sun J, Zhu YJ, Shi CR et al (2010) Laparoscopic radical excision of urachal remnants with recurrent infection in infants. J Endourol 24:1329–1332
Na Q, Liu C, Cui H et al (2011) Immediate repair compared with delayed repair of congenital omphalocele: short-term neonatal outcomes in China. J Int Med Res 39:2344–2351
Khank K, Khan MY, Khan MJ et al (2010) Delayed primary closure of giant omphalocele: gradual closed-reduction followed by open fascial closure. J Med Sci 18:4–7
Baird R, Gholoum S, Laberge JM et al (2010) Management of a giant omphalocele with an external skin closure system. J Pediatr Surg 45:E17–E20
Hurley HJ, Knepper BC, Price CS et al (2013) Avoidable antibiotic exposure for uncomplicated skin and soft tissue infections in the ambulatory care setting. Am J Med 126:1099–1106
Nass A, Ein SH (2011) A pediatric surgeon’s 35-year experience with pilonidal disease in a Canadian children’s hospital. Can J Surg 54:39–42
Sebire NJ, Fowler D, Ramsay AD (2004) Sacrococcygeal tumors in infancy and childhood; a retrospective histopathological review of 85 cases. Fetal Pediatr Pathol 23:295–303
Meier JD, Grimmer JF (2014) Evaluation and management of neck masses in children. Am Fam Physician 89:353–358
Orozco-Covarrubias L, Lara-Carpio R, Saez-De-Ocariz M et al (2013) Dermoid cysts: a report of 75 pediatric patients. Pediatr Dermatol 30:706–711
Tan SY, Stevens MJ, Mueller CM (2013) A novel laparoscopic-assisted approach to the repair of pediatric femoral hernias. J Laparoendosc Adv Surg Tech A 23:946–948
Wright MF, Scollay JM, McCabe AJ et al (2011) Paediatric femoral hernia—the diagnostic challenge. Int J Surg 9:472–474
Troja A, Käse P, El-Sourani N, et al (2014) Treatment of esophageal perforation: a single-center expertise. Scand J Surg. doi:10.1177/1457496914546435
Meakins JL (2002) Innovation in surgery: the rules of evidence. Am J Surg 183:399–405
Acknowledgments
This study was supported by the endowment of the Robert M Filler Chair of Surgery at The Hospital for Sick Children.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Zani-Ruttenstock, E., Zani, A., Bullman, E. et al. Are paediatric operations evidence based? A prospective analysis of general surgery practice in a teaching paediatric hospital. Pediatr Surg Int 31, 53–59 (2015). https://doi.org/10.1007/s00383-014-3624-5
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00383-014-3624-5