Development of Guidelines in Endosurgery of Inguinal Hernia

Governments and health insurers increasingly demand transparent quality control mechanisms. A new type of reimbursement “pay for performance” is under discussion. Therefore, the development and implementation of guidelines constitutes an important step towards the introduction of optimal diagnostic and therapeutic concepts with the aim to improve the quality of treatment. Guidelines should define standards to help the surgeon in his daily work find the best surgical strategy for his patient.

The Guidelines are essentially based on a medicine which relies heavily on statistical methods (Evidence-Based Medicine, EBM), but also allow to deal with “eminence”-based statements in a critical way. Already 200 years ago, P.Ch.A. Louis postulated:” Thus a therapeutic agent cannot be employed with any discrimination or probability of success in a given case, unless its general efficacy, in analogous cases, has been previously ascertained; therefore I conceive that without the aid of statistics nothing like real medicine is possible.” Opponents of EBM argue that, in view of the uniqueness of the patient, clinical studies are of little value. However, in spite of these criticisms, it is generally accepted today that classifications, rules, laws and scientific theories cannot be developed without identifying the common features of large patient populations or diseases; variety in itself warrants statistical methods. To answer specific questions in a particular case, the surgeon should be able to draw from pertinent, high-quality, well-documented biometric studies to choose the most appropriate therapy for his patient. However, as the studies often suffer from methodical flaws, esp. from the heterogeneity of data, it needs caution and deep clinical experience when applying results of EBM to an individual case, even if elaborate metaanalytic techniques have been developed to allow for a differential evaluation of the study results.

The authors of the following guidelines are aware of these problems and conscious of the responsibility they undertake when describing the scientific state of the art in laparoscopic/endoscopic inguinal hernia repair according to the best external evidence available and when making recommendations for the individual case.

Inguinal hernia repair is the most frequent operation in general and visceral surgery worldwide. In the western countries incl. USA, more than 1.5 millions procedures are carried out every year. Thus, hernia repair does not only affect the individual patient, but also has a significant socioeconomic relevance and an important impact on the costs for the health care system. During the 3rd Meeting of the network International Endohernia Society (IEHS) held in Stuttgart, January 2008, live demonstrations of hernia repair performed by 10 surgeons coming from 4 continents showed that guidelines for standardization of operative technique esp. regarding teaching are urgently needed. This prompted a discussion about this challenge which was pursued during the meeting of AHS in Scottsdale/Arizona 2008 with the attendance of R. Fitzgibbons, M. Arregui, F.Köckerling, and P. Chowbey. The need for guidelines was unanimously acknowledged, but with a focus on technique and special problems in transabdominal preperitoneal patch plasty (TAPP) and total extraperitoneal patch plasty (TEP) . The authors were aware of the fact that some overlapping resp. interference with the EHS-Guidelines were not completely avoidable but should be limited as far as possible. Regarding this problem the authors appreciate the valuable contributions M. Miserez gave during the past year.

We started the guideline development process in June 2008 by collecting the most important questions and assembling the most qualified experts in laparoscopic hernia repair. An inviting letter was sent to all well-known laparoscopic hernia specialists having given outstanding contributions to hernia surgery published in peer review journals to participate in a Consensus Conference organized February 2009 in Delhi by P. Chowbey. The following questions were asked:

1. Are you willing to participate?

2. Are you interested in an active participation?

3. In your opinion what are the most important questions in endoscopic hernia surgery?
(e.g. TAPP or TEP, to fix or not to fix, etc.) Please make a ranking and send it to me (fax
is possible: 0049 711 743493).

4.. Are you (you can create a working group) ready to answer one of these questions
according to the literature and your own data, thus you are able to give an
recommendation at the conference?

5. If yes, please inform us about the topic you want to look for.

On the basis of the answers received, 14 topics were identified as most important and 14 surgeons declared their willingness to draft the respective guideline.

In a second step, the experts were asked to:
1. search the literature regarding the topic at hand.
2. graduation of the papers acc. to the Oxford hierarchy of evidence (following the advice of Dr. S. Sauerland) as outlined below consisting of the following 5 levels:

1A          Systematic review of RCTs (with consistent results from individual studies)

1B           RCTs (of good quality)

2A          Systematic review of 2b studies (with consistent results from individual studies)

2B           Prospective comparative studies (or RCT of poorer quality)

2C           Outcome studies (analyses of large registries, population-based data, etc.)

3              Retrospective comparative studies, case-control studies.

4              Case series (i.e. studies without control group).

5              Expert opinion, animal or lab experiments.

3. For the recommendations, use the following grading scale---

A    consistent level 1 studies => strict recommendations ("standard", "surgeons must do it.")

B    consistent level 2 or 3 studies or extrapolations from level 1 studies => less strict wording ("recommendation", "surgeons should do it.")

C    level 4 studies or extrapolations from level 2 or 3 studies => vague wording ("option", "surgeons can do it.")

D    level 5 evidence or troublingly inconsistent or inconclusive studies at any level => no recommendation at all, describe options.

However, there often is a need to upgrade or downgrade a recommendation because the outcome is so important or the clinical preference is so strong. This is possible, but needs to be explained in the commentary text ---

and
4. prepare a paper to present at the Consensus Conference in Dehli.

In Dehli ( Consensus Conference and 4th Meeting of the International Endohernia Society (IEHS) 18.-21. 02. 2009), the papers were discussed first in the round of experts and one day later during the plenary session attended by several hundreds of participants. During the following months, the authors drafted the first version of their specific chapter including all the suggestions they had received during the Conference . These first versions had been send to our biometric advisor, Dr. S. Sauerland, for reviewing and then distributed to all the other experts for critics, remarks, and supplements. During these weeks, countless mails and revisions of papers were exchanged to achieve definitive guidelines which all experts could agree upon. In addition, two meetings that brought to gether most of the authors and the steering committee took place in September 2009 during the AHS/EHS/APHS Meeting in Berlin and in the December 2009 in Stuttgart respectively.

The guidelines focus on technique and perioperative management of laparoscopic/endoscopic inguinal hernia repair. They are not intended as competing alternatives to the EHS guidelines although there is some overlap, esp. regarding risk factors for pain and selection of mesh. The advantages of the guidelines presented here are: 1. Papers published up to 01.02.2009 could be included, in so far literature used here being more up to date. 2. The authors come from Europe, America, and Asia; in so far, the guidelines are, effectively, global. 3. The authors use the Oxford hierarchy of evidence comprising 5 levels; thus, big case series could be included, all together giving a more realistic representation of generally used practice.

In summary, the guidelines have been developed by leading hernia surgeons coming from Europe, America, and Asia, working in high spirits and in an atmosphere of deep friendship. The result is a truly global achievement pointing to the future. We wish to thank all contributors for their tireless efforts and their unwavering dedication to hernia surgery without any remuneration or compensation even for traveling expenses..

If you do a PubMed literature research using the term “ hernia surgery”, you will find 29523 publications. The Guidelines should assist the surgeon in his clinical practice to make the right decision and to improve his technical performance. For validation and agreement, every expert received at least twice all the chapters written by the other authors. All comments and critics were seriously discussed with the respective author and, if necessary, the statements and recommendations were revised accordingly. In addition, the steering committee carefully reviewed every paper. Furthermore, the Guidelines were sent to Surgical Endoscopy for external peer review.

The Guidelines are valid until December 2013. The update meeting will be organized in due time by the first and last author.