Miscellaneous


Chapter 6


Miscellaneous


6.1Training in Hernia Surgery: Hernia Compact—Young Surgery as a 3-Day Further Education Course


6.2Hernia Register: Outcome Research in Hernia Surgery




6 Miscellaneous


6.1 Training in Hernia Surgery: Hernia Compact—Young Surgery as a 3-Day Further Education Course


Ralph Lorenz, Bernd Stechemesser, and Wolfgang Reinpold


Training surgical residents in hernia surgery is a particular challenge today. Many doctors in training are dis-satisfied with current hernia surgery training.12 This is especially due to:


The variety of available methods nowadays.4


The enormous variety of materials (meshes and fixation systems).4


The increased complexity of the procedures.


The lack of training procedures.


The growing shift of “uncomplicated” hernia operations from the universities and higher teaching hospitals to the ambulant sector.4


The absence of standards and guidelines for the individual operation techniques.


Altered hospital structures with increasing emphasis on economy.


A lack of structures in further education.12


A lack of evidence regarding training and further education models.


Poor training of mentors and those in charge of further education.12


Added to this are the following special features:


The “best operation technique” employed in practice is often not technically justified. It is usually guided by where and under which external conditions the operation takes place.4


Rotation of surgical trainees to a special ambulant surgery institution appears useful in view of the increasing shift of uncomplicated hernia procedures to the ambulant sector.6


The learning curve for endoscopic hernia procedures (especially totally extraperitoneal [TEP]) is generally regarded as longer than for open hernia repair.9


Significantly longer operation duration is described in the course of the learning curve,10,18 while serious complications may also occur at the same time.10


Surgical training can be radically improved by an additional special anatomy course. The nerve identification success rate during inguinal hernia operations was increased significantly.2 Simulated operations on cadavers increase surgical skills.3 Furthermore, use of simulation models and other virtual technologies can improve and speed up the training of resident doctors in the area of hernia surgery.16,18


6.2 Hernia Register: Outcome Research in Hernia Surgery


Ferdinand Köckerling, Dietmar Jacob, and Christine Schug-Paß


Hernia is the most frequent diagnosis worldwide requiring surgery. Of the just under 7 billion people on earth, roughly 1 million will develop an inguinal hernia in their lifetime. According to estimates of the international hernia societies, 20 million inguinal hernias are operated on annually worldwide. In Germany, 275,000 inguinal hernias and just under 100,000 abdominal wall hernias are currently treated annually.11


Despite the high number of hernia surgery procedures, the results are anything but satisfactory. In Germany, the rates of both recurrence and chronic groin pain after inguinal hernia operations are over 10%.15


More than 100 different operative methods have been described for managing inguinal hernias. Year on year, new hernia meshes and fixation techniques for these meshes come into the market without scrutiny of their effectiveness in clinical studies. Guidelines on the treatment of inguinal hernia in adults were first issued in 2009 by the European Hernia Society (EHS).14 Also, the development of binding classifications of inguinal and abdominal wall hernias took place only in the past few years.7,8 The International Endohernia Society guidelines on endoscopic inguinal hernia repair procedures were published in 2011.1


The results of many clinical studies have only limited application to routine management.17 Systematic review articles, which are accepted as the highest level in evidence-based medicine and have a major influence on health policy decisions, only perpetuate this problem, as they summarize the available evidence from individual studies. Routine management, however, takes place in a complex context. What is important for patients is the ultimate outcome of the actual treatment.17


The task of applied healthcare research is to assist implementation of the knowledge generated by evidence-based science in routine clinical practice, evaluate it, and ultimately research the outcome.


Based on this framework, hernia surgery is thus an ideal area for healthcare research, as it is performed on both an ambulant and inpatient basis in hospitals and medical practices. Thus, specific healthcare structures are examined at the same time.


The aim of Herniamed, a non-profit project, is ultimately to improve quality across the entire spectrum of hernia surgery. For instance, it was shown in Denmark that there was a significant reduction in recurrence rates following introduction of a hernia registry.5 The demand of the society to deliver outcome quality after surgery is accordingly becoming ever louder.13


6.2.1 Patient Data and Methodology


Project

The non-profit Herniamed society was founded in 2009 to implement the hernia surgery outcome research project. This is a network of German-speaking surgeons particularly interested in hernia surgery, which will be international in future due to cooperation with the EHS.


The key aspect of the Herniamed project is an internet-based registry in which all interested hospitals and surgeons can easily and quickly input the hernia operations they have performed according to a well-founded scientific standard. The treatment results are followed up for 10 years so that late problems can be identified. Based on these results, the best treatment options for patients can be elaborated from the latest information by constant analysis and publications.


The database includes all forms of abdominal wall hernias, such as inguinal, umbilical, incisional, and epigastric hernias. In addition, data regarding internal hernias and the rarer parastomal and hiatal hernias are included. The German Hernia Society (DHG) has now established participation in a quality assurance study as a requirement for hernia center certification.


Informed Consent

Prior to the operation, each patient is asked to sign an informed consent form that includes data protection consent after his doctor has given him detailed information. The aims of the general data capture are mentioned and he is informed that the anonymous treatment and follow-up data will be sent to the central database of the non-profit society Herniamed. The data are stored only when the patient gives his consent; the data can be deleted at any time at the patient’s wish.


Recording of Clinical Data

General Part

All data from patients included in the Herniamed registry are recorded prospectively in special study forms by the treating doctors. Each form is configured specifically according to hernia type in the current EHS classification.


Patient Data

Patients are asked about risk factors that can influence hernia pathogenesis and the development of postoperative complications, such as chronic obstructive pulmonary disease (COPD), bronchial asthma, diabetes mellitus, aortic aneurysm, immunosuppression, corticosteroid therapy, smoking, clotting disorders, use of antiplatelet drugs (or whether these were discontinued in good time before the operation) and use of coumarin derivatives.


Patients’ current health status is recorded according to the American Society of Anesthesiologists (ASA) grading. Patients are graded preoperatively by the treating anesthetist into grade I-IV based on systemic diseases (ASA 1: normal healthy patient, ASA 2: patient with mild systemic disease, ASA 3: patient with severe systemic disease, ASA 4: patient with severe systemic disease that is constantly life-threatening).


All previous operations in the abdomen and groin region are classified as laparoscopic/endoscopic or open and noted down.


Preoperative pain is reported by the patients using a numerical analog scale (NAS). This is a self-assessment scale from 0 to 10, where 0 corresponds to no pain and 10 to the most severe pain. The pain event must occur within 4 weeks preoperatively.


Operation Data

Inpatient or ambulant care is recorded and whether the operation is urgent (emergency within 24 hours) or elective. The form of anesthesia is classified as local, spinal, or general anesthesia.


The operative documentation includes the surgeon, any incarceration, bowel resection, operation time, antibiotic therapy (single shot, a few days, no therapy), and whether this is a primary operation or the number of previous recurrences and their management. All currently licensed meshes are listed by manufacturers and can be checked, ensuring clear identification. The effective width and length of the meshes used and mesh fixation (suture, tacks, glue) are documented. Use of a drain is recorded. Tacks and glue used are also listed and recorded precisely by the manufacturer and on the product.


Complications

Bleeding or injuries of blood vessels, stomach, spleen, bowel, and liver are noted as intraoperative complications. Postoperative complications are divided into surgical and general complications. The predefined surgical complications comprise secondary bleeding, bowel injury, suture dehiscence, impaired wound healing, seroma, infection, symptoms of obstruction, and whether reoperation was performed.


The predefined general complications comprise fever (> 38.0°C, > 1 day), hypertensive crisis, gastritis/ulcers, renal failure, pleural effusion, diarrhea, heart failure, pulmonary embolism, myocardial infarction, COPD/asthma, urinary tract infection, coronary heart disease (CHD), thrombosis, pneumonia, and perioperative mortality.


Pain

Postoperative pain is documented like preoperative pain using the NAS. In this category, the worst pain event within 7 days postoperatively is recorded. Analgesic use and duration (in days) are recorded and any existing nerve lesions and dysesthesia are noted.


European Hernia Society Classification

All hernia types included in the hernia quality assurance are coded by the surgeon according to the current EHS classification (where applicable).


Epigastric hernias are classified as small (< 2 cm), medium (≥ 2–4 cm), or large (≥ 4 cm). The vertical and horizontal diameters of the hernial orifice are stated in cm. The choice of operation method consists of the following procedures: laparoscopic IPOM, open IPOM, open onlay, open inlay, open sublay, open with direct suture (absorbable, nonabsorbable), mesh insertion and defect tightening by direct suture (absorbable, nonabsorbable).


Inguinal hernias are first classified by their location into medial, femoral, lateral, and scrotal. They are further classified according to the orifice size into type I (< 1.5 cm), type II (1.5–3 cm), and type III (> 3 cm). The choice of operation method consists of the Bassini repair (absorbable suture, nonabsorbable suture), the Shouldice repair (absorbable suture, nonabsorbable suture), the Lichtenstein repair, TEP, transabdominal preperitoneal (TAPP) mesh repair, plug, transinguinal preperitoneal patch (TIPP), hernial sac closure (absorbable suture, nonabsorbable suture), and mesh insertion is recorded.


Incisional hernias are classified according to their location into midline and lateral defects. Hernias in the midline are classified more precisely as subxiphoid (M1), epigastric (M2), umbilical (M3), infraumbilical (M4), and suprapubic (M5). Lateral incisional hernias are classified as subcostal (L1), flank (L2), iliac (L3), and lumbar (L4). The vertical and horizontal extents of the defect are measured and recorded as W1 (< 4 cm in width), W2 (≥ 4–10 cm), and W3 (≥ 10 cm). The choice of operation method consists of the following procedures: laparoscopic intraperitoneal onlay mesh (IPOM), open IPOM, open onlay, open inlay, open sublay, and open direct suture (absorbable, nonabsorbable). In addition, mesh implantation and tightening of the defect by direct suture (absorbable, nonabsorbable) are recorded.


Umbilical hernias are classified into small (< 2 cm), medium (≥ 2–4 cm), and large (≥ 4 cm), stating the defect diameter. The choice of operation method consists of the following procedures: laparoscopic IPOM, open IPOM, open onlay, open inlay, open direct suture (absorbable, nonabsorbable). In addition, mesh implantation and tightening of the defect by direct suture (absorbable, nonabsorbable) are recorded.


Parastomal hernias have not yet been classified by the EHS. In the Herniamed project, the type of stoma (ileostomy, colostomy, urostomy) and its location (left upper abdomen, right upper abdomen, left lower abdomen, right lower abdomen) are recorded. The vertical and horizontal extents of the hernial defect are measured. The choice of operation methods consists of the following procedures: laparoscopic IPOM, open IPOM, open onlay, open inlay, open direct suture (absorbable, nonabsorbable). In addition, mesh implantation and tightening of the defect by direct suture (absorbable, nonabsorbable) are recorded.


There is still no EHS classification of hiatal hernias. These are classified according to their location into axial, paraesophageal, mixed hernia, or “upside-down stomach.” Moreover, specific symptoms, such as reflux, dysphagia, regurgitation, pain, anemia/bleeding, or lung conditions, are noted. The vertical and horizontal sizes of the hernia are recorded along with the access route (open, laparoscopic) and the operation method (the Nissen fundoplication [360°], the Toupet fundoplication [270°], fundophrenicopexy, others). Management of the hiatus (hiatoplasty with mesh and suture, hiatoplasty only with suture, hiatoplasty only with mesh) is also documented.


Data Protection

As the data entered with this online portal are very sensitive, the highest data protection standard is applied with the Herniamed database. The data collection software in the Herniamed project was developed by StatConsult and is based on the ClinWise-HealthCare study design tool libraries, which are used for internet-based studies in both clinical and healthcare provision research projects. ClinWise-HealthCare provides the option of storing features that identify the patient, such as name, address, family doctor, as well as the patient codes usual in clinical studies. These data are captured only when they are required for conducting the study (e.g., to generate letters to patients).


A range of measures takes the sensitivity of these data into account. The ClinWise-HealthCare ensures that all data classified as sensitive can be read and modified only by staff assigned to the respective hospital and by the participating surgeons. It is not possible for either the study managers or IT system administrators to view these data. Conversely, this means that the confidential data cannot be restored if a password is lost. Patients can then be categorized only through their specific study patient identification.


The study can be accessed after entering a login and password and selecting the hospital or participating surgeon. The centers and center administrators are created by the study administrator. The center administrator must change his/her password after logging in. A code for this center is then generated automatically and stored encrypted in the database with the study administrator’s password. Only the center administrator can create other users for this hospital.


Data Retrieval

Hospitals and ambulant practice surgeons taking part in the Herniamed registry can view their input data at any time and have them analyzed by the preinstalled software. The data are then available in both tabular and graphic forms. Statistical or extensive computer skills are not required for operation.


Follow-up

All patients are followed up after 1, 5, and 10 years. At each follow-up, the system generates a follow-up inquiry to the patient and referring doctor with the password of the participating hospital or ambulant surgery practice. This follow-up form can be completed by the patient and/or referring doctor and sent back to the treating hospital or surgical practice. The results of this inquiry after 1, 5, and 10 years are then entered into the database again by the clinic or practice. In this way, follow-up data are generated for the registry. If a patient reports problems, it is then up to the hospital or treating surgeon to send the patient an appointment for clinical follow-up so that these problems can be assessed objectively.


Further Reading


[1] Bittner R, Arregui ME, Bisgaard T, et al. Guidelines for laparoscopic (TAPP) and endoscopic (TEP): treatment of Hernia Surg Endosc. 2011; 25:2773–2843


[2] Ergül Z, Kulaço, ğ, lu H, Sen T, et al. A short postgraduate anatomy course may improve the junior surgical residents’ anatomy knowledge for the nerves of the inguinal region. Chirurgia (Bucur). 2011; 106(5):599–603


[3] Holland JP, Waugh L, Horgan A, Paleri V, Deehan DJ. Cadaveric hands-on training for surgical specialties: is this back to the future for surgical skills development? J Surg Educ. 2011; 68(2):110–116


[4] Kavic MS. Teaching and training surgery to the next generation of surgeons. JSLS. 2011; 15(3):279–281


[5] Kehlet H. Chronic pain after groin hernia repair. Br J Surg. 2008; 95(2):135–136


[6] Miguelena Bobadilla JM, Morales García D, Serra Aracil X, et al. [Training of residents in abdominal wall surgery in Spain] Cir Esp. 2013; 91(2):72–77


[7] Miserez M, Alexandre JH, Campanelli G, et al. The European hernia society groin hernia classification: simple and easy to remember. Hernia. 2007; 11(2):113–116


[8] Muysoms FE, Miserez M, Berrevoet F, et al. Classification of primary and incisional abdominal wall hernias. Hernia. 2009; 13(4):407–414


[9] Negro P, D’Amore L, Gossetti F. Mesh plug repair and surgeon’s satisfaction. Hernia. 2010; 14(2):223–224


[10] Paajanen H, Varjo R. Ten-year audit of Lichtenstein hernioplasty under local anaesthesia performed by surgical residents. BMC Surg. 2010; 10:24


[11] Reinpold W. Aktuelle Entwicklung der Hernienchirurgie. Hamburger Ärztebl 2008; 1012–1017


[12] Sádaba JR, Loubani M, Salzberg SP, et al. Real life cardio-thoracic surgery training in Europe: facing the facts. Interact Cardiovasc Thorac Surg. 2010; 11(3):243–246


[13] Sawicki PT. Die Zukunft der deutschen Chirurgie liegt in der Überzeugung durch transparente Ergebnisqualität. Chirurg BDC. 2008; 47(11):371–372


[14] Simons MP, Aufenacker T, Bay-Nielsen M, et al. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009; 13(4):343–403


[15] Soleimanian A. Postoperative Schmerzen im Fokus. Dtsch Ärztebl. 2009; 106(16):752–753


[16] Villegas L, Schneider BE, Callery MP, Jones DB. Laparoscopic skills training. Surg Endosc. 2003; 17(12):1879–1888


[17] Witt CM, Treszl A, Wegscheider K. Externer Validität auf der Spur. Dtsch Ärztebl. 2011; 108(46):2074–2079


[18] Zendejas B, Cook DA, Bingener J, et al. Simulation-based mastery learning improves patient outcomes in laparoscopic inguinal hernia repair: a randomized controlled trial. Ann Surg. 2011; 254(3):502–509; discussion 509–511

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Feb 12, 2020 | Posted by in General Surgery | Comments Off on Miscellaneous
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