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Hernia

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Comparison of hernia registries: the CORE project

  • I. Kyle-Leinhase
  • F. Köckerling
  • L. N. Jørgensen
  • A. Montgomery
  • J. F. Gillion
  • J. A. P. Rodriguez
  • W. Hope
  • F. Muysoms
Open Access
Review

Abstract

Introduction

The aim of the international CORE project was to explore the databases of the existing hernia registries and compare them in content and outcome variables.

Methods

The CORE project was initiated with representatives from all established hernia registries (Danish Hernia Database, Swedish Hernia Registry, Herniamed, EuraHS, Club Hernie, EVEREG, AHSQC) in March 2015 in Berlin. The following categories were used to compare the registries: initiation and funding, data collection and use for certification of hernia centers, patient data and data protection, operative data, registration of complications and follow-up data.

Results

The Danish Hernia Database is the only one to qualify as a genuine national registry where participation is compulsory for entry of all procedures by all surgeons performing a hernia operation. All other registries have to be considered as voluntary and completeness of data depends upon the participating hospitals and surgeons. Only the Danish Hernia Database and the Swedish Hernia Registry are publicly funded. All other registries are reliant on financial support from the medical technology industry. As an incentive for voluntary participation in a hernia registry, hospitals or surgeons are issued a certificate confirming that they are taking part in a quality assurance study for hernia surgery. Due to data protection and privacy regulations, most registries are obliged or have chosen to enter their patient data anonymously or coded. The Danish Hernia Database and Swedish Hernia Registry utilize a national personal patient code. In the Herniamed Registry, patient data are saved in a coded and anonymous format after obtaining the patient’s informed consent.

Conclusion

Despite the differences in the way data are collected for each of the listed hernia registries, the data are indispensable in clinical research.

keywords

Hernia registry Hernia database Clinical trial platform 

Introduction

Randomized clinical trials (RCTs) and meta-analyses are considered the gold standard of evidence-based medicine nowadays [1]. The strength of RCTs rests on their excellent internal validity, which is based largely on the power of randomization to ensure that the only difference between two treatment arms is their exposure to the treatment of interest [2]. But the applicability of RCTs to the care of patients in routine practice is limited. In particular, patients, providers, and concurrent care in the general population are different from those in RCTs, and the generalizability or external validity of RCTs may be limited. Although observational research does not reach the same level of internal validity as RCTs, well-designed observational studies can offer high external validity and provide a unique opportunity to evaluate treatments and their outcomes in routine practice [2]. Many important clinical questions have not, cannot, and will not be addressed in the context of an RCT. In these situations, clinicians rely on information provided by observational research [2]. In a comparison of observational studies and RCTs, the estimates of the treatment effects from observational studies and RCTs were similar in most cases [3]. Registries are ongoing prospective observational data-collection repositories [4]. A registry is defined as a systematic collection of a clearly defined set of health and demographic data for patients with specific health characteristics, held in a central database for predefined purposes [5]. Medical registries can serve different purposes, for instance as a tool to monitor and improve the quality of care or as a resource for research [5]. To be useful, data in a medical registry must be of good quality [5]. To optimize the quality of medical registry data, the participating centers should follow certain procedures designed to minimize inaccurate and incomplete data [5]. The intended use of registry data determines the necessary properties of the data [5].

In 1992, surgeons from eight Swedish hospitals initiated a registry for inguinal and femoral hernia repair [6]. The aim of the registry was to report on the operative techniques used and to analyze outcome measures in order to stimulate quality improvement [6]. A number of national and international registries have since been added [6, 7, 8, 9, 10, 11, 12].

The aim of this manuscript is to explore the databases of these hernia registries and compare them in content and outcome variables.

Materials and methods

The CORE (Comparison of Hernia Registries in Europe) project was initiated with representatives from all established European hernia registries in March 2015 in Berlin. Initially perceived as a European project, the scope was broadened to also include the Americas Hernia Society Collaboration (AHSQC) Registry. Each registry representative was contacted to present and verify information regarding the registry (Table 1).
Table 1

Representatives of the participating registries

Representatives

Registries

Countries

Abbreviasions

William Hope

Americas Hernia Society Quality Collaboration Registry

United States

AHSQC

Jean Francois Gillion

Club Hernie

France

CH

Lars Nannestad Jørgensen

Danish Hernia Database

Denmark

DHDB

Iris Kyle-Leinhase

Filip Muysoms

EuraHS

Belgium

EuraHS

José Antonio Pereira Rodriguez

Registro Espaniol de Eventraciones

Spain

EVEREG

Ferdinand Köckerling

Herniamed

Germany, Austria, Switzerland

Herniamed

Agneta Montgomery

Swedish Hernia Registry

Sweden

SHR

The following information was obtained: Country(ies) of use, start date of registry, procedures included, compulsory or voluntary data entry, overseeing body, funding, user cost, access route, language, number of active users, whether data are validated and by what method, data analysis provided, and how the data are published. The following categories were used to compare the registries: initiation and funding, data collection and use for certification of hernia centers, patient data and data protection, operative data, registration of complications and follow-up data.

Results

The timeline for launch of registries included in the CORE project is shown in Fig. 1. Prospective hernia surgery registration was pioneered by Erik Nilsson in 1992 with the Swedish Groin Hernia Registry (SGHR) [6]. In 1998 the Danish Groin Hernia Database (DGHD) was established and was subsequently extended to ventral hernias (Danish Hernia Database) in 2007 [7]. The German Herniamed Registry included both inguinal and ventral hernias and was launched in 2009 [9]. In France the Club Hernie (CH) started their ventral hernia registry in 2011 across 30 specialized hernia surgeons [10]. Two registries were launched in 2012: EuraHS [8], and the Spanish Registro Español de Eventraciones (EVEREG) [11]. The Americas Hernia Society Collaboration (AHSQC) Registry followed in 2013 [12].
Fig. 1

Timeline of hernia registries

Compulsory or voluntary participation

The Danish Hernia Database is the only one to qualify as a genuine national registry where participation is compulsory for entry of all procedures by all surgeons performing a hernia operation. All other registries have to be considered as voluntary and completeness of data depends upon the participating hospitals and surgeons (Table 2).
Table 2

Initiation and funding of registries

 

Country

Routes

Release

Initiation

Compulsory or voluntary

Funding

Swedish Hernia Registry

Sweden

Inguinal

1992

Non-profit team of surgeons

Voluntary

National Board of Health and Welfare

Ventral

2007

Danish Hernia Database

Denmark

Inguinal

1998

Danish surgeons, non-profit

Compulsory

Public funding

Ventral

2007

Herniamed

Germany, Austria and Switzerland

Inguinal, primary ventral, incisional, parastomal, hiatal

2009

Non-profit organization, German Hernia Society (DHG)

Voluntary

PFM medical, Storz, FEG, BARD, Ethicon, Braun, MenkeMed, Dahlhausen, Medtronic

Club Hernie

France

Inguinal, primary ventral, incisional, parastomal

2011

Non-profit surgeon incentive

Voluntary

Bard, Cousin, Medtronic, Peters

EuraHS

Europe

Primary ventral incisional, parastomal,

2012

Non-profit organization, European Hernia Society (EHS)

Voluntary

Medtronic, FEG, BARD, Ethicon

Hiatal, inguinal, open abdomen, abdominal wall closure, prophyl. meshes

2015

Evereg

Spain

Incisional

2012

Surgeons’ incentive/B Braun

Voluntary

B. Braun

AHSQC

United States of America

Inguinal, primary ventral, parastomal

2013

Non-profit organization, Americas Hernia Society (AHS)

Voluntary

Bard, Allergan, Intuitive, Medtronic, W. L. Gore

National vs international registries

Most hernia registries only record data on hernia operations conducted in their own country. The Herniamed Registry is used in the German-speaking countries Switzerland, Austria and Germany. EuraHS with a multilingual interface is intended for use at international level (Table 2).

Funding

Only the Danish Hernia Database and the Swedish Hernia Registry are publicly funded. All other registries are reliant on financial support from the medical technology industry (Table 2).

Case numbers

The case numbers in the various registries will of course greatly differ in accordance with how long a hernia registry has been in existence, the number of participating hospitals and surgeons as well as with the size of the respective country (Table 3).
Table 3

Data collection and certification

 

Routes

Language

Data entry

Active users

Registered cases

Percentage of all hernias in the country

Complete data necessary for inclusion in analyses

Certification for the surgeon/institution

Swedish Hernia Registry

Inguinal

Swedish

Surgeon and follow-up by educated register secretary/nurse

90 centers

Inguinal: > 240, 000

> 95%

Yes

No certification is provided

Primary ventral, incisional, parastomal

> 10 centers

Primary ventral: > 2800

Incisional and parastomal: > 1800

15%

Yes

Danish Hernia Database

Inguinal (including femoral)

Danish

Surgeon

> 300

Inguinal: > 200,000

90%

Yes

No certification is provided

Ventral: incisional, umbilical, epigastric, port-site, parastomal, other (Spigeli, lumbar, etc.)

Ventral: > 45,000 (umbilical: > 22,500

Incisional: > 11,500

Epigastric: > 6500

Port: > 1500

Parastomal: > 1100)

80%

Yes

Herniamed

Incisional, parastomal, hiatal, inguinal, umbilical, epigastric

English, German

Surgeon

> 500 in Germany, Austria, Switzerland

Inguinal: > 290,000

Umbilical: > 70,000

Incisional: > 50,000

Epigastric: > 16,000

Hiatal: > 9000

Parastomal: > 2000

15–20%

Yes

User certificates defined by certain outcome criteria

Club Hernie

Primary ventral, incisional, inguinal,

parastomal,

giant incisional

French

Surgeon and independent clinical research assistants

50

Inguinal: > 17,700

Ventral: > 7000

2–3%

Yes

Continuing medical education credits

EuraHS

Primary ventral, incisional, parastomal

English, German, French, Italian, Spanish, Polish

Surgeon

> 100 all over Europe

Incisional > 4175

Inguinal > 800

Hiatal: > 300

Open abdomen > 400

No data available for Europe

No

Certificate for registration from EuraHS

Hiatal, inguinal, open abdomen, abdominal wall closure, prophyl. meshes

English, German, Dutch

No data available for Europe

No

Evereg

Only incisional hernias, no primary hernias

Spanish

Surgeon

113 hospitals in Spain only

> 7300

No data available for Spain

Yes

No certification is provided

AHSQC

Primary, incisional, parastomal, inguinal

English

Surgeon, clinical teams, patient

> 200

> 20,000

No data available for USA

Yes

American Board of Surgery Maintenance of Certification Part IV; Centers for Medicare and Medicaid Services Qualified Clinical Data Registry

Certification of participation

As an incentive for voluntary participation in a hernia registry, hospitals or surgeons are issued a certificate (EuraHS, AHSQC, Herniamed) confirming that they are taking part in a quality assurance study for hernia surgery. Since participation in the Herniamed Registry constitutes a basic prerequisite for obtaining certification as a hernia center from the German Hernia Society (DHG), the DHG has defined certain outcome criteria (Table 3).

Data protection

Due to data protection and privacy regulations, most registries are obliged or have chosen to enter their patient data anonymously or coded. Registries often use only the patient’s age or year of birth and mostly only a unique case identification number. The DHDB and SHR use a national personal patient code. In the Herniamed Registry, patient data are saved in a coded and anonymous format after obtaining the patient’s informed consent. The latter can be deleted at any time upon the patient’s request. All data classified as sensitive may be read and edited only by the treating institution for follow-up of the patients (Table 4).
Table 4

Patient data

 

Routes

Indentification

Contact details

Date of birth

BMI

Occupation

Smoker

Sport/exercise

Risk factors

Comorbidities

Swedish Hernia Registry

Inguinal

Anonymous, gender

No

Yes

Yes

No

Yes

No

Immunosuppression, collagen-related disease, increase risk for bleeding

Diabetes, pulmonary disease

Primary ventral, incisional, parastomal

Immunosuppression, collagen-related disease, bleeding disease, steroids

Danish Hernia Database

Inguinal

National identity code (CPR)

Yes

Yes

No

No

No

No

No

No

Port-site, primary ventral, incisional, parastomal

Yes

Yes

Yes for incisional and parastomal hernia

Herniamed

Incisional, parastomal, hiatal, inguinal, umbilical, epigastric

No, only treating institution

No

No

Yes

No

Yes

No

Aneurysm, immunosuppression, thrombocyte aggregation inhibitors, coumarin derivate, coagulopathy, smoking

COPD, asthma, diabetes

Club Hernie

Primary ventral, incisional, inguinal, parastomal, giant incisional

Anonymous, gender

No

Age only

Yes

Yes

Yes

Yes

Aneurysm, immunosuppression, thrombocyte aggregation inhibitors, anticoagulant, personal history of hernia surgery, radiotherapy, chronic medical disease

ASA grading, diabetes, Hepatic disease, COPD, dysuria, constipation

EuraHS

Primary ventral, incisional, parastomal, hiatal, inguinal, open abdomen, abd. wall closure, prophyl. meshes

Anonymous, gender

No

Year only

Yes

Yes

Yes

Yes

Aneurysm, collagen-related disease, immunosuppression, thrombocyte aggregation inhibitors, personal history of hernia surgery

cardiac disease, COPD, diabetes, arterial hypertension, pulmonary disease, hepatic disease, renal disease, malignant disease

Evereg

Incisional

Anonymous, gender

No

Yes

Yes

No

Yes

No

Anticoag, antiplatelet, immunosupressants, smoking, personal history of hernia surgery

COPD, diabetes, cardiac disease, arterial hypertension, hepatic disease, renal disease, malignant disease

AHSQC

Primary ventral, incisional, parastomal, inguinal

Yes

Yes

Yes

Yes

No

Yes

Yes

Anticoagulant use, antiplatelet use, immunosuppressant use, nicotine use and route, history of hernia operation/open abdomen/myofascial release/surgical site infection, MRSA, currently active infection

Liver failure, ascites, HTN, diabetes, dialysis, COPD, dyspnea, inflammatory bowel disease, aneurysm

COPD Chronic obstructive pulmonary disease, MRSA Multiresistant Staphylococcus aureus

Patient variables

In addition to the patient’s age and gender, most registries also record details of previous operations, risk factors and comorbidities (Tables 4, 5). Only a few registries record the patient’s occupation or information on sporting or exercise activities.
Table 5

Operative data

 

Routes

Pre-op data collection

Use of classifications (EHS)

Anatomical considerations

Operating time

Antibiotic use

Reducibility of the hernia

Defect closure

Registration of concomitant abdominal surgery

Swedish Hernia Registry

Inguinal

Yes

Size and localization

Yes

Yes

Yes

Yes

No

Yes, but no report of type

Primary ventral, incisional, parastomal

Yes

Yes

Danish Hernia Database

Inguinal

No

No

Yes

No

No

No

Yes

Yes, but no report of type

Port-site, primary ventral, incisional, parastomal

Yes, only for incisional and parastomal

Herniamed

Incisional, parastomal, hiatal, inguinal, umbilical, epigastric

Yes

Yes

Yes

Yes

Yes

No

Yes

No

Club Hernie

Primary ventral, incisional, inguinal, parastomal, giant incisional

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

EuraHS

Primary ventral, incisional, parastomal, hiatal, inguinal, open abdomen, abd. wall closure, prophyl. meshes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Evereg

Incisional

Yes

No

Yes

Yes

No

No

Yes

Yes

AHSQC

Primary ventral, incisional, parastomal, inguinal

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Operative data

Most registries record details of the operation such as urgency of the operation, hernia classification, hernia localization, operating time, operative technique, anesthesia type, mesh type, fixation technique, defect closure, drain utilization and antibiotic prophylaxis (Table 5).

Intra- and postoperative complications

Intra- and postoperative surgical and general complications are recorded and vary among registries (Table 6).
Table 6

Registration of complications

 

Routes

Intraoperative wound contamination

Intraoperative complications

Postoperative complications

Mesh infection

Mesh removal

Post-surgical death

Intra-hospital pain

Swedish Hernia Registry

Inguinal

No

Bleeding and injuries to other organs, cardiac and pulmonary, technical problems

Hematoma, urinary retention, infection, severe pain, reoperation (bleeding, infection, severe pain, ileus, other).

Complication is graded:

Mild, severe, life-threatening

Superficial, deep and reoperation.

Yes

30-day mortality

No

Primary ventral, incisional, parastomal

Yes

Bleeding and injuries to other organs, cardiac and pulmonary, technical problems, bladder injury, intestinal damage, severity of the injury and equipment failure

Bleeding, seroma/hematoma, SSI, mesh infection, intestinal injury, ileus, non-surgical complications, others

Superficial, deep and reoperation

No

30-day mortality

No

Danish Hernia Database

Inguinal

No

No

No (data obtained from the National Patient Registry)

No

No

30-day mortality

No

Port-site, primary ventral, incisional, parastomal

Yes, only for incisional and parastomal

Herniamed

Incisional, parastomal, hiatal, inguinal, umbilical, epigastric

Yes

Bleeding and injuries to other organs

Complications within 30 days, non-surgical and surgical complications (bleeding, wound healing disorder, deep infection, seroma, hematoma), complication-related reoperations

Yes (deep infection)

No

Yes

Yes

Club Hernie

Primary ventral, incisional, inguinal, parastomal, giant incisional

Yes

Bleeding, adhesions, technical problems and injuries to other organs

Complications within 30 days, Clavien-Dindo grading, non-surgical complications, SSO, Surgical others, length of stay, ICU requirement, unplanned return to OR,

Re-admissions within 30 days

Yes

Yes

Yes

Yes

EuraHS

Primary ventral, incisional, parastomal, hiatal, inguinal, open abdomen, abd. wall closure, prophyl. meshes

Yes

Bleeding, adhesions, technical problems and injuries to other organs

Bleeding, intestinal injury, impaired wound healing, ileus, SSI, seroma, non-surgical complications; Clavien-Dindo grading

Superficial, deep and reoperation

Yes

Yes

Yes, but not for all routes

Evereg

Incisional

Yes

Yes

Yes

Yes

Yes

Yes

Yes

AHSQC

Primary, incisional, parastomal,

inguinal

Yes

Bleeding, adhesions, technical problems and injuries to other organs

Yes

Yes

Yes

Yes

No

Follow-up data

Further variations are observed in the follow-up parameters and protocols as well as the follow-up achievements of the registries (Tables 7, 8). This can be explained by a huge variation in the structure of healthcare systems in different European countries. The quality and frequency of routine clinical follow-up varies due to clinical and financial limitations. Patients who experience postsurgical complications often do not present to the initial operating surgeons or institution.
Table 7

Follow-up data part 1

 

Routes

Time scale post-op follow-up

FU achievements

Swedish Hernia Registry

Inguinal

1 month, re-entry for a recurrence

> 90%

Primary ventral, incisional, parastomal

1, 6 months

> 90%, respective 50%

Danish Hernia Database

Inguinal, port-site, primary ventral, incisional, parastomal

Until patient death or emigration from data linking with the Danish Patient Registry

100% for all included patients

HerniaMed

Incisional, parastomal, hiatal, inguinal, umbilical, epigastric

1, 5, 10 years

Per contract with surgeon > 85%

Club Hernie

Primary ventral, incisional, inguinal, parastomal, giant incisional

1 month by the surgeon clinically, 2 years and 5 years systematic control done by phone questionnaires by independent clinical research assistant blinded to the technique used. Additional if needed

> 85% at 2y FU for all correctly registered patients

EuraHS

Primary ventral, incisional, parastomal, hiatal, inguinal, open abdomen, abd. wall closure, prophyl. meshes

1 month, 1 year, 2 years; additional time points between and after the fixed follow-up moments are possible

> 50% for 1 year; big differences in users

Evereg

Incisional

1 month, 6 months, 1 year, 2 years. Additional if it’s needed

> 35%

AHSQC

Primary ventral, incisional, parastomal, inguinal

1 month, 6 months, 1 year, 2 year, each year after operation

90% 30 day; targeted long-term follow-up (based on individual populations of interest)

Table 8

Follow-up data part 2

 

Routes

Post-operative complications

Post-operative pain

Seroma

Infection

Recurrence

Reoperation

Mortality

QoL measurements

Swedish Hernia Registry

Inguinal

Registered by the coordinator

Yes

Yes

Yes

At reoperation

Yes

Yes

IPQ 2

Primary ventral, incisional, parastomal

Yes

Yes and at reoperation

No

Danish Hernia Database

Inguinal, port-site, primary ventral, incisional, parastomal

Only if requiring reoperation or re-admission

No

Only if requiring reoper. or re-adm.

Only if requiring reoper. or re-adm.

Only if requiring reoper. or re-adm.

Yes

Yes, derived from national identity code

No

HerniaMed

Incisional, parastomal, hiatal inguinal, umbilical, epigastric

Secondary bleeding, intestinal lesion, wound healing disorder, ileus, deep infection

Pain (VAS scale)

Yes

Yes

Yes

Yes

Yes

No

Club Hernie

primary ventral, incisional, inguinal, parastomal, giant incisional

SSI, post-op bulging, mesh infection

Yes

Yes

SSI, post-op bulging, mesh infection

Yes

Yes

Yes

Club Hernie QoL Score

EuraHS

Primary ventral, incisional, parastomal, hiatal, inguinal, open abdomen, abd. wall closure, prophyl. meshes

SSI, post-op bulging, mesh infection

VAS, chronic pain: Cunningham classification

Yes

Yes

Yes

Yes

Yes

EuraHS QoL score, Giqli score

Evereg

Incisional

Yes

Chronic pain, VAS

Yes

Yes

Yes

Yes

Yes

No

AHSQC

Primary ventral, incisional, parastomal, inguinal

SSI, SSO, NSQIP complications

Yes

Yes

Yes

Yes

Yes

Yes

HerQLes, NIH PROMIS

VAS visual analog scale, SSI surgical site infection, SSO surgical site occurance, NSQIP National Surgical Quality Improvement Program, QoL quality of life, HerQLes hernia-related quality-of-life survey, Gigli score gastrointestinal quality of life index, NIH PROMIS National Institute of Health patient-reported outcome measurement information system

Outcome measurement tools

All registries deliver feedback to their participating hospitals, surgeons and research groups via annual reports and Excel exported files (Table 9). Since registries have no proven system for checking the validy of entered data, they can suffer from selection and input bias. This is always a limitation of all data analyses from registries.
Table 9

Provision of data and validation

 

Routes

Data analysis provided

Validation

Swedish Hernia Registry

Inguinal

Annual report on website and report to each center; individual surgeons get their results via the center; publication of data on the website, reports on national and international congresses

Random external validation; selected units are monitored each year by a specially educated team

Primary ventral, incisional, parastomal

Individual surgeons get their results via the center; publication of data on national and international congresses

Not at the moment, planned

Danish Hernia Registry

Inguinal, port-site, primary ventral, incisional, parastomal

National education programs; feedback to surgeon; reports for research projects; publications in international papers; publication of data on international congresses

High validity has been demonstrated between patients´ files and entered data in the registry. Moreover, data are validated on an annual basis against certain quality standards, defined for groin and ventral hernia repair

HerniaMed

Incisional, parastomal, hiatal, inguinal, umbilical, epigastric

Study reporting per route and per section (demographic, status, surgery, mesh, complications, pain) possible. Excel export in real time for surgeons and groups; publication of data

Validation of the data via the German Hernia Society; 1st year: participant has to sign that he/she entered 90% of all hernia operations; after 3 years random audit

Club Hernie

Primary ventral, incisional, inguinal parastomal, giant incisional

Excel export in real time for surgeons and groups; real time comparisons with the group; publication of data on national and international congresses

Asking the patient, the clinical research assistant makes a retro-control of the surgeon’s input. In case of any difference, a control of the medical chart is done

EuraHS

Primary ventral, incisional, parastomal, hiatal, inguinal, open abdomen, abd. wall closure, prophyl. meshes

Excel export in real time per route or per case, case summary function, publication of data on international congresses. Annual report on website

Data validation is done by the constributing surgeons, as they are the owner of their data.

Evereg

Incisional

Excel export in real time for surgeons and groups; data report only for members of board; comparison with the group only available for the Executive Committee; publication of data on international congresses

Annual monitoring by an Executive Committee

AHSQC

Primary ventral, incisional, parastomal, inguinal

Real-time risk adjusted reports provided, comparing individual surgeon or hospital performance compared to collaborative; yearly individual surgeon reports; collaborative-wide analyses

Systematic data assurance including completion and accuracy

Discussion

Within the scope of the CORE project, representatives from seven hernia registers gathered to compare different aspects of their hernia registers. The CORE project examined aspects such as financing, data collection, certification, patient data, operative data, complications and follow-up of the patients. As registries were developed during various time periods where hernia surgery techniques and focus on outcomes have differed over time, differences between registries can be found. Financial resources have also had an impact on the quality of registries as have the ideas of individual surgeons.

It would be desirable to directly compare and combine data from the various hernia registries; therefore, the present analysis suggests potential adjustments to the way data are collected to improve data comparability in the future. The recommendations for reporting outcomes should be given particular attention [13].

Despite the differences in the way data are collected for each of the listed hernia registries, the data are indispensable in clinical research. As a consequence of the numerous innovations in hernia surgery (surgical procedures, meshes, fixation devices), hardly any other area of surgical study has such a high need for clinical trials and data collection, comparison and analysis. Registries play a vital role in this innovation process [14]. In addition, there is insufficient public funding available to perform RCTs [15, 16]. Furthermore, the costs for conducting RCTs have increased dramatically over the last decades [17]. Therefore, RCTs should be more feasible embedded within registries [18].

It has been shown that the introduction of the Danish Hernia Database improved the quality of inguinal hernia surgery from a national perspective [19]. A review based on three European hernia registries demonstrated the range of insightful findings that can be gleaned from hernia registries [20]. Registries can also play an important role in monitoring new devices by the industry (post marketing surveillance) [21]. This is of paramount importance as registries are called upon to provide more data for this specific purpose, because in the context of the current regulation environment at least in the European Union countries, the need of post marketing surveillance of medical devices has increased. As the main aim of the new European Union Medical Device Regulation is better patient safety industry, insurance companies and governments should ultimately contribute to fund hernia registries.

Currently, over 170 analyses from various hernia registries (Danish Hernia Database—http://www.herniedatabasen.dk 84; Swedish Hernia Registry—http://www.svensktbrackregister.se 55; Herniamed—http://www.herniamed.de 22; EuraHS—http://www.eurahs.eu 5; AHSQC—http://www.ahsqc.org 5; Club Hernie—http://www.club-hernie.com 1; EVEREG—http://www.evereg.es 1) have been published. The number of published articles clearly indicates that RCTs and registry-based observational studies have become partners in the evolution of medical evidence in hernia surgery [20]. As there is a discrepancy between the actually published data from hernia registries and the number listed in PubMed the use of the registry name as key word for the publication should be obligatory.

Many important questions in the field of hernia surgery have only been studied in registry studies [20]. Thus, the registers in hernia surgery are of great importance for clinical research. One clear advantage of the registry concept is having the ability to detect and analyze low rate potentially clinically relevant or even catastrophic events. Due to the increasing complexity in hernia surgery, hernia centers are increasingly being established worldwide [22].

Public media are increasingly aware of the fact that surgery can only be improved if its results are known [23]; the registry data are increasingly used for quality control [24], for example, in the certification of hernia centers [25]. A hernia center should be required to participate in a registry and submit as complete as possible data on all hernia patients [25].

Limitation of all data analysis from registries is always selection and input bias. The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) mandates that participating hospitals assigns a NSQIP trained clinical reviewer to collect data on a stratified sampling of patients. Ongoing education for the reviewers as well as auditing is designed to ensure data reliability. This can be a model for the future, but calls for adequate financial support. This model can also prevent misuse of a registry by participating hospitals for marketing purposes.

In summary, while the seven existing hernia registries worldwide may differ in structure, together they contribute to raising the quality of hernia surgery. Assurance of data quality is critical to registries. This aspect should be taken into account in the evaluation of registry data. It would be desirable to harmonize outcome variables. The registries are of great importance for clinical research and are complimentary to RCTs for quality assurance, monitoring innovations, and potential certification of hernia expert centers. Combining all registry data in a common database would be desirable to allow additional knowledge to be gained.

Notes

Authors’ contribution

All authors were responsible for their registry and provided all relevant information’s about their registry in the manuscript. All authors carefully checked the manuscript and gave advices for corrections. All authors gave their final approval for the current version of the manuscript.

Compliance with ethical standards

Conflict of interest

LNJ, AM and JAPR declare no conflict of interest. IKL declares conflict of interest directly related to the submitted work. JFG, WH and FM declare conflict of interest not directly related to the submitted work. FK declares conflict of interest directly and not directly related to the submitted work.

Ethical approval

This study did not need approval from an ethic committee.

Human and animal rights

This study does not contain any studies with participants or animals performed by any of the authors.

Informed consent

Informed consent was not required for this study.

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Copyright information

© The Author(s) 2018

Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Authors and Affiliations

  • I. Kyle-Leinhase
    • 1
  • F. Köckerling
    • 2
  • L. N. Jørgensen
    • 3
  • A. Montgomery
    • 4
  • J. F. Gillion
    • 5
  • J. A. P. Rodriguez
    • 6
  • W. Hope
    • 7
  • F. Muysoms
    • 1
  1. 1.EuraHS and Department of SurgeryMaria Middelares HospitalGhentBelgium
  2. 2.HERNIAMED and Department of Surgery and Center for Minimally Invasive Surgery, Academic Teaching Hospital of Charité Medical SchoolVivantes Hospital SpandauBerlinGermany
  3. 3.DANISH HERNIA DATABASE and Digestive Disease Center, Bispebjerg HospitalUniversity of CopenhagenCopenhagenDenmark
  4. 4.SWEDISH HERNIA REGISTRY and Department of Clinical SciencesSkåne University Hospital Malmö, Lund UniversityMalmöSweden
  5. 5.CLUB HERNIE and Unité de Chirurgie Viscérale et DigestiveHôpital Privé d’AntonyAntonyFrance
  6. 6.EVEREG and Hospital Universitario del MarBarcelonaSpain
  7. 7.AHSQC and New Hanover Regional Medical CenterWilmingtonUSA

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