Hiatal hernia recurrence after open surgery - a systematic review regarding risk factors

2020/2021 Ana Carolina Domingues de Oliveira Rodrigues Amarante Recorrência da hérnia do hiato após cirurgia aberta – uma revisão sistemática acerca de fatores de risco / Hiatal hernia recurrence after open surgery – a systematic review regarding risk factors março, 2021 Mestrado Integrado em Medicina Área: Medicina Clínica Tipologia: Dissertação Trabalho efetuado sob a Orientação de: Doutor Silvestre Porfírio Ramos Carneiro Trabalho organizado de acordo com as normas da revista: Acta Médica Portuguesa Ana Carolina Domingues de Oliveira Rodrigues Amarante Recorrência da hérnia do hiato após cirurgia aberta – uma revisão sistemática acerca de fatores de risco / Hiatal hernia recurrence after open surgery – a systematic review regarding risk factors março, 2021 Hiatal hernia recurrence after open surgery – a systematic review regarding risk factors Recorrência da hérnia do hiato após cirurgia aberta – uma revisão sistemática acerca de fatores de risco Ana Amarante 1, Silvestre Carneiro 2,3 Correspondência: Ana Amarante Alameda Prof. Hernâni Monteiro, Hospital de S. João 4200-319 Porto, Portugal [email protected] 1 Faculty of Medicine, University of Porto, Porto, Portugal 2 Department of Surgery, Centro Hospitalar Universitário São João, Porto, Portugal 3 Department of Surgery and Physiology, Faculty of Medicine, University of Porto, Porto, Portugal 6 Hiatal hernia recurrence after open surgery – a systematic review regarding risk factors Resumo Introdução As hérnias do hiato ocorrem principalmente devido a fragilidade da membrana frenoesofágica e de outras estruturas próximas, como os pilares do diafragma. Isto resulta na migração intratorácica através do hiato esofágico de uma porção do tubo digestivo, o que acarreta um risco aumentado de complicações como refluxo, esofagite ou mesmo estrangulamento. A reparação cirúrgica é efetuada tradicionalmente por cirurgia aberta ou, mais recentemente, de forma minimamente invasiva. Os fatores que determinam a recorrência das hérnias do hiato após cirurgia aberta não estão ainda completamente esclarecidos. Métodos Seguindo as guidelines PRISMA, realizou-se uma revisão sistemática da literatura incidindo nos fatores de recorrência da hérnia do hiato após cirurgia aberta. Recorreuse a duas bases de dados de referências, a Medline e a Scopus. Resultados Identificaram-se um total de 1070 referências. Após exclusão de duplicados, artigos não disponíveis ou irrelevantes, analisaram-se qualitativamente 18 artigos. Discussão Vários estudos consideram o impacto do tipo de apresentação (urgente, não urgente), um maior IMC, idade ou o tipo de cirurgia (com ou sem procedimento antirefluxo associado). Contudo, ainda não foi encontrada uma associação entre estes fatores e o aumento do risco de recorrência. Um estudo descreve uma associação entre complicações graves de refluxo e o maior risco de recorrência. Não existe uniformidade na definição de recorrência nem como a diagnosticar. Conclusão Os determinantes da recorrência após reparação aberta da hérnia do hiato permanecem controversos. Demonstra-se a necessidade de estudos prospetivos que permitam uma compreensão mais aprofundada com melhor evidência sobre as causas de recorrência da hérnia do hiato e como esta pode ser prevenida. 7 Abstract Introduction Due to fragility of phrenoesophageal membrane and nearby structures such as diaphragmatic crura (among other causes), hiatal hernias can develop. This results in intrathoracic migration of a portion of the digestive tube through the esophageal hiatus, with added risk of complications such as reflux, esophagitis, or even strangulation. This surgical repair can be performed traditionally with open surgery or, more recently, by minimal invasive surgery. The factors that determine hiatal hernia recurrence after open repair are not yet well understood. Methods Following the PRISMA guidelines, we performed a systematic review of literature regarding risk factors for recurrence after open surgery for hiatal hernia repair. We used both Medline and Scopus libraries. Results We identified a total of 1070 records. After exclusion of duplicates, unavailable and nonrelevant articles, we included 18 studies in our qualitative analysis. Discussion Several studies consider the role of acute presentation, higher patient BMI, older age, or the type of surgery with or without a reflux procedure. However, a lack of significant association between these factors and a higher recurrence risk remains. A significant association was found between serious reflux complications the risk of recurrence, in one study. There is also a lack of consensus regarding what constitutes a recurrence, and how to diagnose it. Conclusion The factors related to the recurrence of hiatal hernia after open repair remain controversial. There is a need for prospective studies that allow for a more comprehensive understanding specially with better evidence on why hernias recur and how can this be prevented. Key words Hiatal hernia, Recurrence, Fundoplication, Gastropexy, Gastroplasty 8 Introduction Hiatal hernia occurs when a portion of the digestive tube that usually sits below the diaphragm slides upwards through the esophageal hiatus to the thoracic cavity. This can happen, especially in older age groups, due to weakness of phrenoesophageal membrane, widening of intercrural space or increased abdominal pressure. Because the abdominal pressure is normally higher than thoracic pressure, this weakness leads to the creation of a hernia sac. The true incidence of this phenomenon is difficult to assess due to a lack of symptoms. In these cases, hiatal hernias are discovered in radiographic exams or during abdominal surgery, being incidental findings. When patients develop symptoms, these are commonly related to reflux.1 There are four types of hiatal hernias. The most common one is type I hernia, usually referred to as sliding hernia, defined as the herniation of gastroesophageal junction to the thoracic cavity. This hernia type is normally corrected only when patients become symptomatic. In type II hernia, or true paraesophageal hernia, while the gastroesophageal junction remains in place, another portion of the stomach herniates into the thoracic cavity. Type III hernia is also called combined hernia, since both the gastroesophageal junction and a different section of the stomach herniate together, as if both previous hernias occurred concurrently. A type IV hernia occurs when a portion of another abdominal organ, usually the colon or small bowel, herniate through the hiatus along with the stomach. Regarding treatment to types II-IV, correction frequently comes at the time of diagnosis, due to risk of acute gastric volvulus and strangulation, in addition to the more debilitating symptoms that patients experience. Hernia repair can be done either by an open or laparoscopic approach.2 Surgical correction of hiatal hernias can be done either by laparotomy, thoracotomy or by a minimally invasive approach, that is, laparoscopy, with the latter having comparable results to open surgery. Despite the good clinical results, some series suggest recurrence occurs as often as in 59% of patients,3 which is problematic since surgical repair of recurrences is associated with a higher morbidity and mortality rate,4 due to the added complexity of this type of surgery. However, not all patients that experience recurrence will need additional surgery, with some minor hernias being managed successfully with pharmacological treatment and lifestyle changes.3 This systematic review will focus on the factors associated with recurrence after open surgical treatment of hiatal hernia. By shedding light on who is at a higher risk of recurrence, we hopefully will contribute to provide a more adequate treatment to patients with this condition, resulting in less recurrence in the future. 9 Methods Search strategy We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We surveyed Medline (through Pubmed) and Scopus libraries, and we included interventional or observational studies published until 1 November 2020. Search terms consisted of: "Hernia, Hiatal"[Mesh] AND "Recurrence"[Mesh]. The broadness of these search terms aimed to provide a minimum loss of relevant material. Following extraction of citations to EndNote V.X9.3.3, we proceeded to deduplicate references both via the software functionality and manually. Then, we performed a screening based on title and abstract relevance. Details regarding study identification, screening and inclusion are available on figure 1. Selection of studies We developed the eligibility criteria prior to the search: Studies had to inform on type of hernia (I-IV), diagnostic assessment, recurrence criteria (radiological or symptomatic) and follow up period. This was meant to ensure that it would be possible to retrieve conclusions from the study data and allow for comparison between studies. Study design could be observational or interventional. Only full-text papers were included, excluding other publication types. Data extraction and qualitative analysis We retrieved data regarding recurrence, follow-up period and sample size and included it in an extraction table (table 1). We also performed a risk of bias analysis using Study Quality Assessment Tools from National Institutes of Health for each of the studies included in this review. Then, we performed a qualitative analysis of the data which is the subject of this review. Results Record search in both Medline and Scopus retrieved 1070 results. After identifying and excluding duplicates both manually and automatically, we screened 705 records for title/abstract relevance according to the objective of this review. Based on relevance, we excluded 568 records, and an additional 31 records were excluded due to full-text unavailability. After this process, we assessed 106 full-text articles for eligibility, according to the inclusion criteria previously defined. We excluded 43 articles based on hernia type criteria, 45 based on diagnostical assessment criteria, 46 based on 16 such as the preexistent reflux complications mentioned by some authors, that could be responsible for higher recurrence. There was, indeed, a significant association between more serious reflux complications such as erosive esophagitis or stricture and the recurrence of type I hernia. As far as the type of surgery is concerned, the surgeon and surgical center preference and experience are not to be dismissed, however many advised against the non-selective use of antireflux procedures, such as fundoplications, and favored the Hill gastropexy specially with giant hernias, and the Collis gastroplasty specially in obese patients. Hiatal hernia recurrence remains a difficult topic to assess. Adding to the scarcity of studies covering specifically this entity following open repair, a problem persists with the lack of consensus in the definition of recurrence, as previously stated. Other causes are related to the fact that hiatal hernia repair is not a very frequent surgery, and most centers are abandoning open repairs.2 Adding to this difficulty, some authors advocate to operate only when hernias become symptomatic, rather than at diagnosis, even for type II-IV hernias.23 There are not, to our knowledge, other systematic reviews concerning this topic. However, in literature, there are some commonly accepted recurrence factors. An increase in intra-abdominal pressure, thus highlighting the need for adequate techniques to prevent of added stress to the repair. The hiatal hernia size, which could justify the use of mesh, even though the necessity for this is not yet consensual. And some authors also consider obesity as a risk factor,24 even though a higher BMI was not associated with recurrence in this review. Lastly, the presence of short esophagus carries an added risk, particularly in recurrence of type I hernia, which could be diminished by new diagnose tools and the addition of Collis gastroplasty to the repair, that is, the antireflux procedure.25 Controversy remains regarding the necessity of the antireflux procedure, since for some authors this should only be done selectively, while others consider it the standard treatment.23 Other reviews report similar difficulties due to the lack of standardized outcomes and definitions.26,27 There are limitations inherent to this systematic review. The first one is that only two major databases were consulted, neither being a surgical one, and no gray literature was searched. A meta-analysis could have helped to add to the validity of the review conclusions. And there is a lack of recent studies regarding this subject, which is most probably attributed to declining interest in open repair and the growing interest in minimal invasive surgery. However, there are some strong points too. We performed a thorough search in our chosen databases and did not limit the studies in terms of year of publication or language, which could add to a broader pool of eligible articles, bearing in mind that this is a theme on which there are not many studies available, even less recent 17 ones. We also performed a risk of bias analysis using a validated tool and considered those results when analyzing conclusions. As previously stated, most centers are favoring laparoscopic repairs over open surgery.2 Even though recurrence factors following laparoscopic repair are more lengthily studied,3 this shift in care highlights a need to further understand how these factors compare to those that arise following open surgery. This valuable insight could help determine the best patient care, along with the surgeon experience and preference, beyond the patient surgical risk. Even though there is room and necessity for prospective studies to fill in the gaps in knowledge regarding this subject, it is also possible to reflect on the applicability of the results provided by this review. The most consensual recurrence factor across studies was related to the severe complications of reflux. This could mean that the timing of diagnosis and, consequently, of surgery is occurring later than ideal. We hope to provide, with this review, a basis for the discussion of recurrence factors following open surgery, regarding not only the patient related ones but also those concerning the surgery itself. 18 Figure 1. PRISMA flow chart for the selection of articles. Records identified in Medline (through Pubmed) (n = 427) Screening Included Eligibility Identification Records identified in Scopus (n = 643) Total identified records (n = 1070) Records screened (n = 705) Records excluded based on title/abstract relevance (n=568) Records excluded based on fulltext availability (n= 31) Full-text articles assessed for eligibility (n = 106) Full-text articles excluded (n= 88) Hernia type (n= 43) Diagnostical assessment (n= 46) Recurrence criteria (n= 47) Follow up period (n= 28) Studies included in qualitative synthesis (n = 18) Duplicates excluded (n = 365) 19 Table 1. Selected studies characteristics First Author Year Sample size Hernia type Recurrence rate (%) Follow-up period Quality analysis1 Bahadorzadeh 1975 29 I, symptomatic 13.8 (radiological) 1 month to 60 months (mean 20 months) Fair Díez Tabernilla 2009 47 II, III, IV 4.3 (radiological) 12 months to 228 months (median 144 months) Good El Lakis 2017 524 II (2.7%), III (83.6%), IV (13.7%) (over 50% gastric herniation) 17.3 (radiological) mean 4.3 months Good Ferri 2005 18 II, III (36% - most common), IV 44 (radiological) 27 months to 144 months (mean 104 months) Good Gatzinsky 1980 90 I (86.7%), II (3.3%), III (17.8%) 15.5 (radiological) 12 months to 120 months (mean 60 months) Good Guijarro 1989 47 I, III 4.3 (radiological) mean 60 months Fair Hashemi 2000 27 III "large" 15 (radiological) 5 months to 166 months (mean 17 months) Good Karmali 2008 47 II, III, IV (over 33% gastric herniation) 9 (radiological) 2 months to 58 months (median 21 months) Good Laan 2017 118 II, III, IV (over 75% gastric herniation) 8.4 (radiological) 1 month to 175 months (median 22 months) Good Low 2005 72 II (2.8%), III (72.2%), IV (25%) (over 50% gastric herniation) 18 (radiological) 2 months to 84 months (mean 29.8 months) Good 20 Lugaresi 2016 60 III (73.3%), IV (26.6%) 8 (radiological) median 180 months Fair Maher 1978 65 I, II 23 (radiological) 14 months to 18 months (mean 15.6 months) Fair Myers 1995 37 II (70.2%), III (29.8%) 2.7 (radiological) 1.5 months to 129 months (mean 67 months) Fair Nicholson 1976 283 I (87.6%), II (6.7%), III (3.5%) 18 (clinical, radiological) 1 month to 156 months Fair Patel 2004 240 III (91.7%), IV (8.3%) 9.6 (radiological) 1 month to 204 months (mean 42 months) Good Shaikh 2013 24 II, over 50% stomach herniated 8.3 (clinical) mean 46.7 months Good Williamson 1993 119 II (76%), III (24%); "large", 6.7% with volvulus 10.1 (clinical) 6 months to 216 months (median 61.5 months) Fair Zehetner 2011 73 II (over 50% herniated stomach) 24.7 (radiological) 36 months (median 16 months) Good 1 National Institutes of Health Study Quality Assessment Tools, available from https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools 21 Table 2. Patient’s characteristics Bahadorzadeh Nicholson Maher Gatzinsky Guijarro Williamson Myers Hashemi Patel Ferri Low Karmali Díez Tabernilla Zehetner Shaikh Lugaresi El Lakis Laan Males 27 4:6 M:F 41 53 23 44 17 72 10 31 17 22 26 6 159 35 Females 2 24 44 24 75 20 168 15 41 30 68 47 18 365 83 Age range 23-69 (mean 49) mean 52 18-79 (mean 53) 30-84 (mean 58) 37-95 (median 64) 19-85 (mean 69) 31-80 (mean 66) 29-94 (mean 65.3) 41-84 (mean 66) 45-91 (mean 68,7) 43-90 (mean 72) 37-96 (median 67.6) 57-75 (median 65) 35-85 (mean 71) mean 67 60.2±7.7 to 84.5±4.0 37.686.4 (median 71) BMI 30 (71% 25-35, 15% > 35) 28.8± 4.9 28.3 (median) 26.7±4.6 to 30.6±5.1 30.3±5. 0 Co morbidities Gastroduodenal ulcer 29.7%, biliar litiasis 31.9%, both 2.1% Arterial hypertension, COPD, coronary/peripheral vascular disease, peptic ulcer disease 14% cardiac, 22% pulmonary, 42% arterial hypertensi on, 4% diabetes, 12% smokers, 11% alcoholics Arterial hypertensi on, kidney problems, diabetes Past abdominal surgery 24.6% 17.8% 36% 64% Some patients ASA category 40 % ASA > 2 38 % ASA > 2 ASA 3 (median) 25 % ASA > 2 Symptom Pyrosis 59% Majority 98% 33% 28% 60% 96% Dysphagia 47% 24% 6% 50% 70% 36% 28% 43% 32% Postprandial pain 62% 74% 70% 68% 44% 42% 72% Regurgitation 39% Majority 40% 18% Some patients 22 Gastrointestinal hemorrhage or Anemia 15% 19% 9% 34% 41% 33% 29% 52% Some patients 7% Dyspnea 22% Some patients 4% Vomiting Majority 50% 62% Some patients Eructation Majority 11% 23 References 1. Siegal SR, Dolan JP, Hunter JG. Modern diagnosis and treatment of hiatal hernias. Langenbecks Arch Surg. 2017;402:1145-51. 2. Rochefort M, Wee JO. Management of the difficult hiatal hernia. Thorac Surg Clin. 2018;28:533-9. 3. Witek TD, Luketich JD, Pennathur A, Awais O. Management of Recurrent Paraesophageal Hernia. Thorac Surg Clin. 2019;29:427-36. 4. Kao AM, Otero J, Schlosser KA, Marx JE, Prasad T, Colavita PD, et al. One More Time: Redo Paraesophageal Hernia Repair Results in Safe, Durable Outcomes Compared with Primary Repairs. Am Surg. 2018;84:1138-45. 5. Bahadorzadeh K, Jordan PH. Evaluation of the Nissen fundoplication for treatment of hiatal hernia: use of parietal cell vagotomy without drainage as an adjunctive procedure. Ann Surg. 1975;181:402-8. 6. Maher JW, Hollenbeck JI, Woodward ER. An analysis of recurrent esophagitis following posterior gastropexy. Ann Surg. 1978;187:227-30. 7. Gatzinsky P, Bergh NP, Larsson S. Husfeldt hernia repair: indications and results. A follow-up study. Scand J Thorac Cardiovasc Surg. 1980;14:129-35. 8. El Lakis MA, Kaplan SJ, Hubka M, Mohiuddin K, Low DE. The Importance of Age on Short-Term Outcomes Associated with Repair of Giant Paraesophageal Hernias. Ann Thorac Surg. 2017;103:1700-9. 9. Patel HJ, Tan BB, Yee J, Orringer MB, Iannettoni MD. A 25-year experience with open primary transthoracic repair of paraesophageal hiatal hernia. J Thorac Cardiovasc Surg. 2004;127:843-49. 10. Ferri LE, Feldman LS, Stanbridge D, Mayrand S, Stein L, Fried GM. Should laparoscopic paraesophageal hernia repair be abandoned in favor of the open approach? Surg Endosc. 2005;19:4-8. 11. Zehetner J, DeMeester SR, Ayazi S, Kilday P, Augustin F, Hagen JA, et al. Laparoscopic versus open repair of paraesophageal hernia: the second decade. J Am Coll Surg. 2011;212:813-20. 12. Laan DV, Agzarian J, Harmsen WS, Shen KR, Blackmon SH, Nichols FC, et al. A comparison between Belsey Mark IV and laparoscopic Nissen fundoplication in patients with large paraesophageal hernia. J Thorac Cardiovasc Surg. 2018;156:418-28. 13. Guijarro AA, Palanca MV, Irene JES, Valer CC, Vergeli PS. Treatment of hiatal hernia and gastroesophageal reflux using pexis of the round ligament by the Narbona technic. Rev Esp Enf Ap Digest. 1989;76: 31-4. 24 14. Myers GA, Harms BA, Starling JR. Management of paraesophageal hernia with a selective approach to antireflux surgery. Am J Surg. 1995;170:375-80. 15. Hashemi M, Peters JH, DeMeester TR, Huprich JE, Quek M, Hagen JA, et al. Laparoscopic repair of large type III hiatal hernia: objective followup reveals high recurrence rate. J Am Coll Surg. 2000;190: 553-60. 16. Low DE, Unger T. Open repair of paraesophageal hernia: Reassessment of subjective and objective outcomes. Ann Thorac Surg. 2005;80:287-94. 17. Lugaresi M, Mattioli B, Daddi N, Di Simone MP, Perrone O, Mattioli S. Surgery for Type III-IV hiatal hernia: anatomical recurrence and global results after elective treatment of short oesophagus with open and minimally invasive surgery. Eur J Cardiothorac Surg. 2016;49:1137-43. 18. Williamson WA, Ellis FH, Streitz JM, Shahian DM. Paraesophageal hiatal hernia: is an antireflux procedure necessary? Ann Thorac Surg. 1993;56:447-51. 19. Shaikh I, Macklin P, Driscoll P, de Beaux A, Couper G, Paterson-Brown S. Surgical management of emergency and elective giant paraesophageal hiatus hernias. J Laparoendosc Adv Surg Tech. 2013;23:100-5. 20. Karmali S, McFadden S, Mitchell P, Graham A, Debru E, Gelfand G, et al. Primary laparoscopic and open repair of paraesophageal hernias: a comparison of short-term outcomes. Dis Esophagus. 2008;21:63-8. 21. Díez Tabernilla M, Ruiz-Tovar J, Marino G, García PC, Hernández JDP, Vaisman AC, et al. Paraesophageal hiatal hernia. Open vs. laparoscopic surgery. Rev Esp Enferm Dig. 2009;101:706-11. 22. Nicholson DA, Nohl-Oser HC. Hiatus hernia: a comparison between two methods of fundoplication by evaluation of the long-term results. J Thorac Cardiovasc Surg. 1976;72:938-43. 23. Lebenthal A, Waterford SD, Fisichella PM. Treatment and controversies in paraesophageal hernia repair. Front Surg. 2015;20:13. 24. Laliberte AS, Louie BE. Short-Term and Long-Term Outcomes of Paraesophageal Hernia Repair. Thorac Surg Clin. 2019;29:405-14. 25. Lal P, Tang A, Sarvepalli S, Raja S, Thota P, Lopez R, et al. Manometric Esophageal Length to Height (MELH) Ratio Predicts Hiatal Hernia Recurrence. J Clin Gastroenterol. 2020;54:e56-e62. 26. Draaisma WA, Gooszen HG, Tournoij E, Broeders IAMJ. Controversies in paraesophageal hernia repair: a review of literature. Surg Endosc. 2005;19:1300-8. 27. Tatum JM, Lipham JC. Recurrent Hiatal Hernia: Evolving Definitions and Clinical Implications. 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NOTA FINAL Para um mais completo esclarecimento sobre este assunto aconselha-se a leitura do Uniform Requirements for Manuscripts Submitted to Biomedical Journals do International Commitee of Medical Journal Editors), disponível em http://www.ICMJE.org. NORMAS PUBLICAÇÃO PRISMA 2009 Checklist Section/topic # Checklist item Reported on page and paragraph/ table # TITLE Title 1 Identify the report as a systematic review, meta-analysis, or both. - MANDATÓRIO Página 1. Hiatal hernia recurrence after open surgery – a systematic review regarding risk factors ABSTRACT Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number. – SEGUIR RECOMENDAÇÕES DA REVISTA Página 7. Introduction: Due to fragility of phrenoesophageal membrane and nearby structures such as diaphragmatic crura (among other causes), hiatal hernias can develop. This results in intrathoracic migration of a portion of the digestive tube through the esophageal hiatus, with added risk of complications such as reflux, esophagitis, or even strangulation. This surgical repair can be performed traditionally with open surgery or, more recently, by minimal invasive surgery. The factors that determine hiatal hernia recurrence after open repair are not yet well understood. Methods: Following the PRISMA guidelines, we performed a systematic review of literature regarding risk factors for recurrence after open surgery for hiatal hernia repair. We used both Medline and Scopus libraries. Results: We identified a total of 1070 records. After exclusion of duplicates, unavailable and non-relevant articles, we included 18 studies in our qualitative analysis. Discussion: Several studies consider the role of acute presentation, higher patient BMI, older age, or the type of surgery with or without a reflux procedure. However, a lack of significant association between these factors and a higher recurrence risk remains. A significant association was found between serious reflux complications the risk of recurrence, in one study. There is also a lack of consensus regarding what constitutes a recurrence, and how to diagnose it. Conclusion: The factors related to the recurrence of hiatal hernia after open repair remain controversial. There is a need for prospective studies that allow for a more comprehensive understanding specially with better evidence on why hernias recur and how can this be prevented. INTRODUCTION Rationale 3 Describe the rationale for the review in the context of what is already known. – MANDATÓRIO O rationale corresponde à justificação da importância da revisão sistemática Página 8. “Despite the good clinical results, some series suggest recurrence occurs as often as in 59% of patients,3 which is problematic since surgical repair of recurrences is associated with a higher morbidity and mortality rate,4 due to the added complexity of this type of surgery.” Annex 2 PRISMA 2009 Checklist Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS). - MANDATÓRIO Página 8. “This systematic review will focus on the factors associated with recurrence after open surgical treatment of hiatal hernia. By shedding light on who is at a higher risk of recurrence, we hopefully will contribute to provide a more adequate treatment to patients with this condition, resulting in less recurrence in the future.” METHODS Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number. – FACULTATIVO Não aplicável porque não foi seguido nenhum protocolo externo/institucional. Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale. – MANDATÓRIO É altamente recomendado, de acordo com as boas práticas da Cochrane, que não sejam aplicados critérios de exclusão baseados na língua e/ou data de publicação dos estudos. Página 9. “We developed the eligibility criteria prior to the search: Studies had to inform on type of hernia (I-IV), diagnostic assessment, recurrence criteria (radiological or symptomatic) and follow up period. This was meant to ensure that it would be possible to retrieve conclusions from the study data and allow for comparison between studies. Study design could be observational or interventional. Only full-text papers were included, excluding other publication types.” Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched. – MANDATÓRIO Em consonância com as boas práticas da Cochrane, é mandatório que se verifique pesquisa em pelo menos duas bases de pesquisa bibliográfica (idealmente, deverão ser pesquisadas duas bases generalistas e uma específica da área). No caso de revisões sistemáticas de estudos experimentais/ensaios clínicos aleatorizados, é altamente recomendado que uma das bases pesquisadas corresponda à CENTRAL ou a bases de ensaios clínicos como a ClinicalTrials.gov. Estudos de revisão da literatura em que a pesquisa decorra numa única base de dados não serão classificados como revisões sistemáticas. Página 9. “We surveyed Medline (through Pubmed) and Scopus libraries” Search 8 Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated. – MANDATÓRIO A query de pesquisa deve ser obrigatoriamente disponibilizada. A utilização de filtros de pesquisa da InterTASC é altamente recomendada (https://sites.google.com/a/york.ac.uk/issg-search-filtersPágina 9. “Search terms consisted of: "Hernia, Hiatal"[Mesh] AND "Recurrence"[Mesh].” PRISMA 2009 Checklist resource/home) Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis). – MANDATÓRIO As fases de selecção dos estudos primários devem ser descritas. Em consonância com as boas práticas da Cochrane, é mandatório que o processo de selecção envolva duas fases (fase de rastreio, em que os registos são seleccionados por título e abstract, e fase de inclusão, na qual se procede à leitura integral dos full texts). Em cada uma destas fases, o processo de selecção deve mandatoriamente envolver dois investigadores actuando de forma independente. Página 9. “Following extraction of citations to EndNote V.X9.3.3, we proceeded to deduplicate references both via the software functionality and manually. Then, we performed a screening based on title and abstract relevance. Details regarding study identification, screening and inclusion are available on figure 1.” “We developed the eligibility criteria prior to the search. Studies had to inform on type of hernia (I-IV), diagnostical assessment, recurrence criteria (radiological or symptomatic) and follow up period. This was meant to ensure that it would be possible to retrieve conclusions from the study data and allow for comparison between studies. Study design could be observational or interventional. Only full-text papers were included, excluding other publication types.” Data collection process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators. – MANDATÓRIO Trata-se de descrever de que forma se procedeu à extracção de dados dos estudos primários. Em consonância com as boas práticas da Cochrane, tal processo deverá envolver dois investigadores de forma independente. Página 9. “We retrieved data regarding recurrence, follow-up period and sample size and included it in an extraction table (table 1). We also performed a risk of bias analysis using Study Quality Assessment Tools from National Institutes of Health for each of the studies included in this review. Then, we performed a qualitative analysis of the data which is the subject of this review.” Página 19. Tabela 1 Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made. – MANDATÓRIO Trata-se de descrever as variáveis para as quais foi obtida informação. Página 9. “recurrence, follow-up period and sample size and included it in an extraction table (table 1)” Página 19. Tabela 1 Risk of bias in individual studies / Risk of bias across studies 12/ 15 Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis. – MANDATÓRIO Em todas as revisões sistemáticas, deverá existir um processo de avaliação da qualidade dos estudos primários. No caso de revisões sistemáticas de estudos experimentais/ensaios clínicos aleatorizados, a aplicação dos critérios de risco de viés (Risk of Bias) da Cochrane é altamente recomendada. No caso de revisões sistemáticas de estudos observacionais, poderão ser seguidos os critérios ROBINS ou os critérios dos National Institutes of Health (https://www.nhlbi.nih.gov/healthPágina 9. “We also performed a risk of bias analysis using Study Quality Assessment Tools from National Institutes of Health for each of the studies included in this review.” Página 19. Tabela 1 PRISMA 2009 Checklist topics/study-quality-assessment-tools). Summary measures 13 State the principal summary measures (e.g., risk ratio, difference in means). – FACULTATIVO. APENAS NECESSÁRIO SE FOR FEITA META-ANÁLISE Não aplicável, uma vez que esta revisão sistemática não se acompanhou de meta-análise. Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I2) for each meta-analysis. – FACULTATIVO. APENAS NECESSÁRIO SE FOR FEITA META-ANÁLISE Não aplicável, uma vez que esta revisão sistemática não se acompanhou de meta-análise. Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified. – FACULTATIVO. APLICÁVEL APENAS SE FOR FEITA META-ANÁLISE Não aplicável, uma vez que esta revisão sistemática não se acompanhou de meta-análise. RESULTS Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram. – MANDATÓRIO Página 9. “Record search in both Medline and Scopus retrieved 1070 results. After identifying and excluding duplicates both manually and automatically, we screened 705 records for title/abstract relevance according to the objective of this review. Based on relevance, we excluded 568 records, and an additional 31 records were excluded due to full-text non availability. After this process, we assessed 106 full-text articles for eligibility, according to the inclusion criteria previously defined. We excluded 43 articles based on hernia type criteria, 45 based on diagnostical assessment criteria, 46 based on recurrence criteria and 28 based on follow-up criteria, to a total of 86 articles excluded. The remaining 18 studies were then qualitatively analyzed regarding patient characteristics, recurrence rate and follow-up period, in consonance with to the goal of this review.” Página 18. PRISMA flowchart / Figura 1 Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations. – MANDATÓRIO Página 9. “We retrieved data regarding recurrence, follow-up period and sample size and included it in an extraction table (table 1).” Página 19. Tabela 1 Risk of bias within and across studies 19/ 22 Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). – MANDATÓRIO Página 9. “We also performed a risk of bias analysis using Study Quality Assessment Tools from National Institutes of Health for each of the studies included in this review.” Página 19. Tabela 1 Results of individual studies 20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot. – FACULTATIVO. APLICÁVEL APENAS Não aplicável, uma vez que esta revisão sistemática não se acompanhou de meta-análise. PRISMA 2009 Checklist SE FOR FEITA META-ANÁLISE Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. – FACULTATIVO. MANDATÓRIO APENAS SE FOR FEITA META-ANÁLISE Não aplicável, uma vez que esta revisão sistemática não se acompanhou de meta-análise. Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). – FACULTATIVO. APLICÁVEL APENAS SE FOR FEITA META-ANÁLISE Não aplicável, uma vez que esta revisão sistemática não se acompanhou de meta-análise. DISCUSSION Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers). – MANDATÓRIO Página 15. “Our evidence suggests older patients might pose a greater risk of recurrence, however the authors that agreed to this failed to prove a significant association. The same situation happens with other factors, such as the preexistent reflux complications mentioned by some authors, that could be responsible for higher recurrence. There was, indeed, a significant association between more serious reflux complications such as erosive esophagitis or stricture and the recurrence of type I hernia. As far as the type of surgery is concerned, the surgeon and surgical center preference and experience are not to be dismissed, however many advised against the non-selective use of antireflux procedures, such as fundoplications, and favored the Hill gastropexy specially with giant hernias, and the Collis gastroplasty specially in obese patients.” Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias). – MANDATÓRIO Página 16. “There are limitations inherent to this systematic review. The first one is that only two major databases were consulted, neither being a surgical one, and no gray literature was searched. A metaanalysis could have helped to add to the validity of the review conclusions. And there is a lack of recent studies regarding this subject, which is most probably attributed to declining interest in open repair and the growing interest in minimal invasive surgery.” Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research. – MANDATÓRIO Página 17. “As previously stated, most centers are favoring laparoscopic repairs over open surgery.2 Even though recurrence factors following laparoscopic repair are more lengthily studied,3 this shift in care highlights a need to further understand how these factors compare to those that arise following open surgery. This valuable insight could help determine the best patient care, along with the surgeon experience and preference, beyond the patient surgical risk. Even though there is room and necessity for prospective studies to fill in the gaps in knowledge regarding this subject, it is also possible to reflect on the applicability of the results provided by this review. The PRISMA 2009 Checklist most consensual recurrence factor across studies was related to the severe complications of reflux. This could mean that the timing of diagnosis and, consequently, of surgery is occurring later than ideal. We hope to provide, with this review, a basis for the discussion of recurrence factors following open surgery, regarding not only the patient related ones but also those concerning the surgery itself.” FUNDING Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review. – SEGUIR RECOMENDAÇÕES DA REVISTA Não há obrigatoriedade de discriminação deste ponto pelas normas da Acta Médica Portuguesa. From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(7): e1000097. doi:10.1371/journal.pmed1000097 For more information, visit: www.prisma-statement.org. Page 2 of 2