Skip to content
DSML.KZ
Publications

Article · British journal of surgery · June 17, 2024

Global access to technologies to support safe and effective inguinal hernia surgery: prospective, international cohort study

Maria Picciochi, Adesoji Oludotun Ademuyiwa, Adewale Adisa, Anita Eseenam Agbeko, Jose Andrés Calvache, Daoud Chaudhry

Ildar Fakhradiyev
Open via DOI

Abstract

Technological advancement is important to improve healthcare quality and safety, especially in surgery1. For patients with an inguinal hernia, mesh and minimally invasive surgery are the two main technologies that have improved healthcare quality and safety2,3. The use of mesh is proven to reduce recurrence4,5. This avoids the need for further repairs, which are technically more challenging and have a higher risk for patients6. The use of minimally invasive surgery has proven advantages in bilateral hernias and in female patients2,3 and is recommended in unilateral repair where appropriate expertise is available2,3. Access to these technologies and the expertise required are not widely or equitably distributed at a global level. As it is the case for other technologies, countries in the Global South have more limited access1. At the same time, in this part of the globe, there is a higher prevalence and a higher burden of disease associated with inguinal hernias7. Several barriers to implementation in the Global South have been identified previously, including costs, distribution, and training8,9. To overcome these, studies reporting the use of mesh based on mosquito net mesh and evaluating training programmes have been conducted10,11. With these efforts and with global investment in new technologies and the expansion of existing technologies, it was expected that there would be an increase in their use in low–middle-income countries. Data assessing this variability have not been collected in a standardized way and are usually reported from single-country or single-region studies5,12. Therefore, identification of areas where improvement is most needed will be key to better inform policymakers. The overarching aim of this study was to evaluate access to technologies that are relevant to the treatment of inguinal hernia patients to identify the areas where improvement is needed. Therefore, the primary aim of this study was to evaluate the use of mesh and predictors of mesh use in elective inguinal hernia repairs and the secondary aims of this study were to evaluate the use of minimally invasive surgery and predictors of minimally invasive surgery use and to evaluate the safety associated with the use of mesh and the use of minimally invasive surgery. This was a pre-planned analysis of an international, multicentre, prospective cohort study of patients undergoing inguinal hernia surgery. Routine and anonymized data were collected and no changes in patient care were made. The study protocol is publicly available (globalsurgeryunit.org/clinical-trials-holding-page/hippo) and was registered in ClinicalTrials.gov (NCT05748886). Approvals were obtained by local principal investigators in each hospital taking part, according to local and national regulations. This study is reported in line with STROBE guidelines13. Any hospital performing inguinal hernia repair was eligible to take part. Each participating hospital identified consecutive patients undergoing primary inguinal hernia repair as the main procedure during a 4-week inclusion window between 30 January and 21 May 2023. Adult patients, defined as older than 16 years, undergoing elective primary inguinal repair were included. Patients operated on via midline incision or converted to midline incision were excluded, considering the complexity inherent to this approach. The use of mesh in open surgery was defined as the primary outcome and was compared across the different income groups, as defined by the World Bank. The use of minimally invasive surgery and complications at 30 days were secondary outcomes. Minimally invasive surgery included both laparoendoscopic and robotic approaches and was defined as per intention-to-treat, therefore converted surgeries to open were included in this group. Postoperative complications were defined according to the Clavien–Dindo classification and these data were collected at 30 days after surgery14. To comprehensively evaluate postoperative complications, surgical-site infection rates and reoperation rates (mapped to surgical approach and use of mesh) were also collected at 30 days after surgery. Data were collected and stored online using a secure server running the Research Electronic Data Capture (REDCap) web application15. The service was managed by the Global Surgery REDCap system hosted at the University of Birmingham, Birmingham, UK. Its security was governed by the policies of the University of Birmingham. Each collaborator involved in data collection was identified and registered by the hospital lead and received personal login details. This allowed secure data entry and storage in REDCap. The data collection methodology was validated previously, in terms of case ascertainment and data accuracy16,17. The hospital lead had access to the data entered by their team. They were responsible for data accuracy and data completeness collected and uploaded from their site. The data were checked centrally and when there were missing data or invalid data, the hospital lead was contacted to complete and correct the data entered. After this, participating hospitals with data completeness less than 95% were excluded. There was no formal sample size calculation for the analysis proposed and all eligible patients were included. To ensure global generalizability of the results and to justify the resources put into the study, a minimum number of 300 centres contributing patient-level data from 70 countries was estimated, based on previous cohort studies (that is GlobalSurg and COVIDSurg studies)16,17. Assuming an average of 30 patients per centre, a minimum sample size of 10 000 patients was predicted. Assuming that the prevalence of mesh use ranges between 70% and 95%, sample size considerations for building a prediction model showed that approximately 2500 subjects would be required to build a model with 7 predictor variables, a prevalence of 95%, and a C-statistic of 0.7 (see Table S1 for full details)18. Sample sizes were estimated using the pmsampsize command in Stata, version 18.0 (StataCorp). Data were mapped to country income groups, defined according to the World Bank (low-income countries, lower-middle-income countries, upper-middle income countries, and high-income countries), as their importance in relation to healthcare access, safety, and quality has been widely recognized6. Continuous non-normally distributed hospital-, patient-, and intraoperative-related variables are presented as median (interquartile range (i.q.r.)) values, whereas categorical variables are presented as frequencies and percentages. The use of mesh and minimally invasive surgery are presented as frequencies and rates across income groups. Postoperative complications, surgical-site infection, and reoperation are presented as frequencies and rates across surgical approach and mesh use groups. Multilevel logistic regression models were used to test factors that could be associated with higher mesh use in open surgery and the use of minimally invasive surgery. Plausible hospital and clinical factors agreed by the Study Management Group were considered and hospital was included as a random effect. For the above analyses, appropriate model fit diagnostics were checked to confirm that validity and model assumptions were maintained for the data. Categories were collapsed when category event rates were too low to be efficiently included in the model, as was the case for income groups. All statistical analyses were performed using R (R Foundation for Statistical Computing, Vienna, Austria; version 4.0.2). P < 0.050 was considered statistically significant. Data were collected from 18 058 patients across 640 centres located in 83 countries. For this study, 14 768 adults undergoing elective primary inguinal hernia repair in 612 centres located in 81 countries were included, as shown in Fig. 1 and Fig. S1. Most of them were operated on in high-income countries (60.4%, 8916 of 14 768). Flow chart of included patients HIC, high-income country; UMIC, upper-middle-income country; LMIC, lower-middle-income country; LIC, low-income country. Included patients had a median age of 60 (i.q.r. 47.0–70.0) years (Table 1), with an absolute median difference of 10 years between patients operated on in high- and low-income countries. Most patients were male (91.7%, 13 539 of 14 768). Regarding their perioperative risk, most were ASA grade I–II (85.9%, 12 691 of 14 768) and without co-morbidities, which was observed across all income groups. The majority of patients presented with symptomatic hernias (86.2%, 12 729 of 14 768) that were unilateral and with an extension limited to the inguinal region (79.4%, 11 733 of 14 768). Intraoperatively, greater than 90.0% of the operations were classified as clean (14 419 of 14 768). Hernia defect size was variable in all income groups, with defects of 1.5–3 cm being the most reported (40.8%, 6031 of 14 768). Hospitals where these patients were operated on were mostly tertiary-level centres (62.4%, 9126 of 14 768) and their funding was mainly provided by the public sector (86.6%, 12 152 of 14 768) (Table S2). Preoperative and intraoperative characteristics of adults undergoing elective inguinal hernia repair Values are n (%) unless otherwise indicated. HIC, high-income country; UMIC, upper-middle-income country; LMIC, lower-middle-income country; LIC, low-income country. Preoperative and intraoperative characteristics of adults undergoing elective inguinal hernia repair Values are n (%) unless otherwise indicated. HIC, high-income country; UMIC, upper-middle-income country; LMIC, lower-middle-income country; LIC, low-income country. In all income groups, patients were more commonly operated on by a senior surgeon (71.0%, 10 487 of 14 768) (Table 2). Most had previous experience of greater than 200 inguinal hernia repairs (53.1%, 7833 of 14 768). There was heterogeneity in the surgical technique chosen to repair inguinal hernia, as shown in Fig

Global Health and SurgeryHernia repair and managementSurgical Simulation and Traininginguinal hernia repairhernia meshminimally invasive hernia repair

More by Ildar Fakhradiyev