Eur J Pediatr Surg 2024; 34(02): 182-188
DOI: 10.1055/a-2196-1755
Review Article

Benchmarks for Pediatric Surgical Registries: Recommendations for the Assessment and Grading of Complications

Omid Madadi-Sanjani
1   Department of Pediatric Surgery, Hannover Medical School, Hannover, Germany
,
Benno M. Ure
1   Department of Pediatric Surgery, Hannover Medical School, Hannover, Germany
› Author Affiliations

Abstract

Procedure-related registries in general surgical practice offer a platform for prospective trials, the pooling of data, and detailed outcome analysis. Recommendations by the Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) collaboration and Outcome4Medicine have further improved the uniform reporting of complications and adverse events.

In the pediatric surgical network, disease-specific registries for rare and inherited congenital anomalies are gaining importance, fostering international collaborations on studies of low-incidence diseases. However, to date, reporting of complications in the pediatric surgical registries has been inconsistent. Therefore, the European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA) recently endorsed the validation of the first severity grading system for children. The planned reform of the European Paediatric Surgical Audit (EPSA) registry, which includes the implementation of the Clavien–Madadi classification, represents a further effort to establish uniform outcome reporting.

This article provides an overview of experiences with surgical registries and complication reporting, along with the potential application of this knowledge to future pediatric surgical practice.



Publication History

Received: 28 September 2023

Accepted: 20 October 2023

Accepted Manuscript online:
23 October 2023

Article published online:
06 February 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ. Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg 2005; 242 (03) 326-341 , discussion 341–343
  • 2 Tevis SE, Cobian AG, Truong HP, Craven MW, Kennedy GD. Implications of multiple complications on the postoperative recovery of general surgery patients. Ann Surg 2016; 263 (06) 1213-1218
  • 3 Low DE, Kuppusamy MK, Alderson D. et al. Benchmarking complications associated with esophagectomy. Ann Surg 2019; 269 (02) 291-298
  • 4 van der Werf LR, Busweiler LAD, van Sandick JW, van Berge Henegouwen MI, Wijnhoven BPL. Dutch Upper GI Cancer Audit (DUCA) group. Reporting national outcomes after esophagectomy and gastrectomy according to the Esophageal Complications Consensus Group (ECCG). Ann Surg 2020; 271 (06) 1095-1101
  • 5 Reynolds JV, Donlon N, Elliott JA. et al. Comparison of esophagectomy outcomes between a National Center, a National Audit Collaborative, and an international database using the Esophageal Complications Consensus Group (ECCG) standardized definitions. Dis Esophagus 2021; 34 (01) doaa060
  • 6 McCulloch P, Altman DG, Campbell WB. et al; Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374 (9695) 1105-1112
  • 7 McCulloch P, Feinberg J, Philippou Y. et al. Progress in clinical research in surgery and IDEAL. Lancet 2018; 392 (10141): 88-94
  • 8 Domenghino A, Walbert C, Birrer DL, Puhan MA, Clavien PA. Outcome4Medicine consensus group. Consensus recommendations on how to assess the quality of surgical interventions. Nat Med 2023; 29 (04) 811-822
  • 9 Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240 (02) 205-213
  • 10 Clavien PA, Barkun J, de Oliveira ML. et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 2009; 250 (02) 187-196
  • 11 Zoeller C, Kuebler JF, Ure BM, Brendel J. Incidence of complications, organizational problems, and errors: unexpected events in 1605 patients. J Pediatr Surg 2021; 56 (10) 1723-1727
  • 12 Sethi MVA, Zimmer J, Ure B, Lacher M. Prospective assessment of complications on a daily basis is essential to determine morbidity and mortality in routine pediatric surgery. J Pediatr Surg 2016; 51 (04) 630-633
  • 13 Madadi-Sanjani O, Zoeller C, Kuebler JF. et al. Severity grading of unexpected events in paediatric surgery: evaluation of five classification systems and the Comprehensive Complication Index (CCI®). BJS Open 2021; 5 (06) zrab138
  • 14 Astolfi D, Wildhaber BE. Letter to the Editor. Classification of pediatric complications: time for a new concept. J Neurosurg Pediatr 2021; 28 (05) 620-620
  • 15 Madadi-Sanjani O, Kuebler JF, Brendel J. et al. Implementation and validation of a novel instrument for the grading of unexpected events in paediatric surgery: Clavien-Madadi classification. Br J Surg 2023; 110 (05) 576-583
  • 16 Schadde E, Ardiles V, Robles-Campos R. et al; ALPPS Registry Group. Early survival and safety of ALPPS: first report of the International ALPPS Registry. Ann Surg 2014; 260 (05) 829-836 , discussion 836–838
  • 17 Buac S, Schadde E, Schnitzbauer AA, Vogt K, Hernandez-Alejandro R. The many faces of ALPPS: surgical indications and techniques among surgeons collaborating in the international registry. HPB (Oxford) 2016; 18 (05) 442-448
  • 18 Linecker M, Björnsson B, Stavrou GA. et al. Risk adjustment in ALPPS is associated with a dramatic decrease in early mortality and morbidity. Ann Surg 2017; 266 (05) 779-786
  • 19 Schnitzbauer AA, Schadde E, Linecker M. et al. Indicating ALPPS for colorectal liver metastases: a critical analysis of patients in the international ALPPS registry. Surgery 2018; 164 (03) 387-394
  • 20 Raptis DA, Linecker M, Kambakamba P. et al. Defining benchmark outcomes for ALPPS. Ann Surg 2019; 270 (05) 835-841
  • 21 Schadde E, Schnitzbauer AA, Tschuor C, Raptis DA, Bechstein WO, Clavien PA. Systematic review and meta-analysis of feasibility, safety, and efficacy of a novel procedure: associating liver partition and portal vein ligation for staged hepatectomy. Ann Surg Oncol 2015; 22 (09) 3109-3120
  • 22 Wanis KN, Buac S, Linecker M. et al. Patient survival after simultaneous ALPPS and colorectal resection. World J Surg 2017; 41 (04) 1119-1125
  • 23 Wanis KN, Linecker M, Madenci AL. et al. Variation in complications and mortality following ALPPS at early-adopting centers. HPB (Oxford) 2021; 23 (01) 46-55
  • 24 Lang H, Baumgart J, Mittler J. Associated Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) Registry: what have we learned?. Gut Liver 2020; 14 (06) 699-706
  • 25 Glinianaia SV, Morris JK, Best KE. et al. Long-term survival of children born with congenital anomalies: a systematic review and meta-analysis of population-based studies. PLoS Med 2020; 17 (09) e1003356
  • 26 Bartlett RH, Roloff DW, Cornell RG, Andrews AF, Dillon PW, Zwischenberger JB. Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 1985; 76 (04) 479-487
  • 27 Nicholls SG, Carroll K, Zwarenstein M. et al; Ethics of Pragmatic Trials project. The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders. Trials 2019; 20 (01) 765
  • 28 Fergusson D, Monfaredi Z, Pussegoda K. et al. The prevalence of patient engagement in published trials: a systematic review. Res Involv Engagem 2018; 4: 17
  • 29 Gottrand F, Ley D, Michaud L, Sfeir R. Importance of an international registry for and collaborative research on esophageal atresia. Front Pediatr 2017; 5: 81
  • 30 Arafat Y, Wei MY, Karanatsios B, Mendis S, Gibbs P, Yeung JMC. Registry randomized controlled trials: the future of surgical trials?. ANZ J Surg 2023; 93 (09) 2059-2060
  • 31 Rao SV, Hess CN, Barham B. et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (study of access site for enhancement of PCI for women) trial. JACC Cardiovasc Interv 2014; 7 (08) 857-867
  • 32 Pereira H, Caldeira D, Teles RC. et al; Investigators of Portuguese Registry on Interventional Cardiology (Registo Nacional de Cardiologia de Intervenção). Thrombus aspiration in patients with ST-elevation myocardial infarction: results of a national registry of interventional cardiology. BMC Cardiovasc Disord 2018; 18 (01) 69
  • 33 Petersen C, Madadi-Sanjani O. Registries for biliary atresia and related disorders. Eur J Pediatr Surg 2015; 25 (06) 469-473
  • 34 Gfroerer S, Theilen TM, Fiegel HC, Esmaeili A, Rolle U. Comparison of outcomes between complete and incomplete congenital duodenal obstruction. World J Gastroenterol 2019; 25 (28) 3787-3797
  • 35 Gfroerer S, Theilen TM, Fiegel HC, Rolle U. Laparoscopic versus open surgery for the repair of congenital duodenal obstructions in infants and children. Surg Endosc 2018; 32 (09) 3909-3917
  • 36 Hoff N, Wester T, Granström AL. Classification of short-term complications after transanal endorectal pullthrough for Hirschsprung's disease using the Clavien-Dindo-grading system. Pediatr Surg Int 2019; 35 (11) 1239-1243
  • 37 Madadi-Sanjani O, Brendel J, Kuebler JF, Ure BM. Definition, documentation, and classification of complications in pediatric surgical literature-a plea for standardization. Eur J Pediatr Surg 2023; 33 (02) 105-113
  • 38 Tucker FD, Morris JK, Neville A. et al; JRC Management Committee. EUROCAT: an update on its functions and activities. J Community Genet 2018; 9 (04) 407-410
  • 39 Pedersen RN, Calzolari E, Husby S, Garne E. EUROCAT Working group. Oesophageal atresia: prevalence, prenatal diagnosis and associated anomalies in 23 European regions. Arch Dis Child 2012; 97 (03) 227-232
  • 40 Kancherla V, Sundar M, Tandaki L. et al. Prevalence and mortality among children with anorectal malformation: a multi-country analysis. Birth Defects Res 2023; 115 (03) 390-404
  • 41 Best KE, Tennant PWG, Addor MC. et al. Epidemiology of small intestinal atresia in Europe: a register-based study. Arch Dis Child Fetal Neonatal Ed 2012; 97 (05) F353-F358
  • 42 Garne E, Rasmussen L, Husby S. Gastrointestinal malformations in Funen county, Denmark: epidemiology, associated malformations, surgery and mortality. Eur J Pediatr Surg 2002; 12 (02) 101-106
  • 43 Šípek A, Gregor V, Horáček J, Šípek Jr A, Klaschka J, Malý M. Prevalence of selected congenital anomalies in the Czech Republic: congenital anomalies of the central nervous system and gastrointestinal tract. Epidemiol Mikrobiol Imunol 2015; 64 (01) 47-53
  • 44 De Vigan C, Goujard J, Vodovar V, Uzan S. Management of the fetus with a correctable malformation in Paris maternity units: evolution 1985-1994. Fetal Diagn Ther 1997; 12 (04) 216-220
  • 45 Garabedian C, Sfeir R, Langlois C. et al; French Network on Esophageal Atresia. Does prenatal diagnosis modify neonatal treatment and early outcome of children with esophageal atresia?. Am J Obstet Gynecol 2015; 212 (03) 340.e1-340.e7
  • 46 Lejeune S, Sfeir R, Rousseau V. et al. Esophageal atresia and respiratory morbidity. Pediatrics 2021; 148 (03) e2020049778
  • 47 Sfeir R, Michaud L, Sharma D, Richard F, Gottrand F. National esophageal atresia register. Eur J Pediatr Surg 2015; 25 (06) 497-499
  • 48 Serinet MO, Broué P, Jacquemin E. et al. Management of patients with biliary atresia in France: results of a decentralized policy 1986-2002. Hepatology 2006; 44 (01) 75-84
  • 49 Chardot C, Buet C, Serinet MO. et al. Improving outcomes of biliary atresia: French national series 1986-2009. J Hepatol 2013; 58 (06) 1209-1217
  • 50 Cömert HSY, Güney D, Durakbaşa ÇU. et al. The effect of postoperative ventilation strategies on postoperative complications and outcomes in patients with esophageal atresia: results from the Turkish Esophageal Atresia Registry. Pediatr Pulmonol 2023; 58 (03) 763-771
  • 51 Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery 1992; 111 (05) 518-526
  • 52 Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg 2013; 258 (01) 1-7
  • 53 Boyle JR. Future of surgical registries. Br J Surg 2021; 108 (07) 740-741
  • 54 Mandavia R, Knight A, Phillips J, Mossialos E, Littlejohns P, Schilder A. What are the essential features of a successful surgical registry? A systematic review. BMJ Open 2017; 7 (09) e017373
  • 55 Breakwell LM, Cole AA, Birch N, Heywood C. Should we all go to the PROM? The first two years of the British Spine Registry. Bone Joint J 2015; 97-B (07) 871-874
  • 56 Dindo D, Clavien PA. What is a surgical complication?. World J Surg 2008; 32 (06) 939-941
  • 57 Dol J, Hughes B, Bonet M. et al. Timing of neonatal mortality and severe morbidity during the postnatal period: a systematic review. JBI Evid Synth 2023; 21 (01) 98-199