The first edition of the Practice Guidelines on Endoscopic Surgery was published on 1 September 2008. A new guidelines committee was established 2 years later in September 2010 to revise the guidelines. With the introduction and spread of robot-assisted and single-port access surgeries for a wide range of applications, endoscopic surgery has evolved at an impressive pace in recent years in Japan. Through various activities, such as the establishment of the Endoscopic Surgical Skill Qualification System, the provision of educational seminars, and the development of the Practice Guidelines on Endoscopic Surgery, the Japan Society for Endoscopic Surgery has been contributing to the promotion of safe practice for endoscopic surgery, including these new techniques. The present situation is complex: sufficient evidence for recommending endoscopic surgeries has been established in some areas, but there remains a lack of well-established evidence in other areas. In the first edition of our guidelines, we mentioned the difficulty in covering such a wide spectrum of medical specialties to which endoscopic surgery should be applied in a standardized format. Such difficulties have also been raised by the members of the External Review Committee. The guidelines clearly specify the surgeons qualified by the Endoscopic Surgical Skill Qualification System as the target population. (The guidelines are applicable in the chest surgery area to surgeons with training experience and skills comparable to those of surgeons accredited by the Endoscopic Surgical Skill Qualification System in other specialties, because the Japanese Association for Chest Surgery does not have a skill qualification system in place. Similarly, in the orthopedic area, a qualification system for qualified spinal endoscopic surgeons is in place, but there is no qualification system available for widely practiced arthroscopic surgeries. Therefore, these guidelines are applicable to surgeons who have comparable training experience and skills to those qualified by the Endoscopic Surgical Skill Qualification System in other areas.) The guidelines shall address the techniques covered by health insurance or the techniques listed as advanced medical care (as of March 2013). The clinical question format shall be used in all areas. The guidelines are prepared for each area and do not address robotic or single-port access surgeries separately. Prof. Takeo Nakayama (Department of Health Informatics, Kyoto University School of Public Health) joined our committee as a special adviser for this revision. Although he proposed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as a new approach to guidelines development, more time was required to allow all committee members from a wide spectrum of areas to understand this method. Therefore, it will be addressed in the next revision. We hope these guidelines will serve as a benchmark to enhance the broader application of endoscopic surgery. Yoshiharu Sakai Chairman of the Guidelines Committee of the Japan Society for Endoscopic Surgery September 2014 These guidelines are applicable to qualified surgeons accredited by the Endoscopic Surgical Skill Qualification System of the Japan Society for Endoscopic Surgery. The guidelines aim to explicitly provide the indication criteria and recommendations for techniques covered by health insurance. These guidelines aim to eliminate over- and under-treatment. These guidelines are designed to promote mutual understanding and will thus be available to members of relevant academic societies and associations. The revision of these guidelines is anticipated to promote the safe and wider application of endoscopic surgeries and to improve the treatment outcomes and benefits to patients. The Japan Society for Endoscopic Surgery shall accept responsibility for the contents of these guidelines. However, the primary physician directly involved in treating each patient shall be responsible for treatment outcomes. The Japan Society for Endoscopic Surgery shall bear no responsibility for such outcomes. The Guidelines Committee established discussions to standardize the description format, level of evidence, and strength of the recommendations with representatives of the relevant societies and associations, including the Japanese Urological Association, the Japanese Society of Endourology, the Japan Society of Gynecologic and Obstetric Endoscopy and Minimally Invasive Therapy, the Japanese Association for Chest Surgery, the Japanese Hernia Society, and the Japanese Orthopaedic Association. The principles of guidelines development were based on surgical techniques currently in use. The techniques of endoscopic surgery addressed were those covered by health insurance or the techniques listed as advanced medical care. A clinical question was elaborated for each technique to specify clearly the indication criteria and strength of the recommendation. Answers to clinical questions determined the strength of recommendations, while subclinical questions provided an overview of the indication criteria for surgery, outcomes, and complications. The levels of evidence are noted for each article included. The following definitions were used for strength of recommendation and level of evidence: The strength of recommendation A: strongly recommended to perform B: recommended C1: may be considered, but there is insufficient scientific evidence C2: not recommended due to lack of evidence D: not recommended Levels of evidence I: based on systematic reviews and meta-analyses II: based on one or more randomized controlled trials III: based on non-randomized controlled trials IV: based on analytic studies (cohort and case-control studies) V: based on descriptive studies (case reports and case series) VI: based on expert panel and individual experts' opinions; not based on patient data We selected two to six key words (in both Japanese and English) for each clinical question and asked the Japan Medical Library Association to perform literature searches. A search was conducted for literature published between 1990 and 2012, and additional literature was included at the discretion of committee members. The structured abstract developed by the Japanese Council for Quality Health Care (Minds) was used as a standardized format. Retrieved literature was categorized according to the levels of evidence definitions. Literature with a lower level of evidence was not included if similar material with a higher level of evidence was available. The strength of the recommendation was determined based on discussions among the committee members from each area. Final drafts were created for each area and reviewed by committee members from each corresponding area. If required, approval was obtained from the board of the professional societies and associations of the area. A public hearing was held during the 26th Annual Meeting of the Japan Society for Endoscopic Surgery (28–30 November 2013). An online public consultation process was initiated after the annual meeting until the end of December 2013, via the Japan Society for Endoscopic Surgery website. Responses to the comments were prepared and released by the end of February 2014. The guidelines will be published in our journal (special issue) and on the website following final approval by the board of governors of the Japan Society for Endoscopic Surgery. The guidelines will not be available in printed form. The copyright of the guidelines created by professional societies and associations shall be held by such professional societies and associations (applicable societies and associations: the Japanese Society of Endourology and the Japanese Association for Chest Surgery). For guidelines other than above, the Japan Society for Endoscopic Surgery holds their copyright. The development of these practice guidelines was funded by the relevant societies and associations, including the Japan Society for Endoscopic Surgery, the Japanese Society of Endourology, the Japan Society of Gynecologic and Obstetric Endoscopy and Minimally Invasive Therapy, and the Japanese Association for Chest Surgery. We accepted no financial assistance from any other organizations or companies. Also, the intentions and interests of each society and association have not influenced the final recommendations. The director member of the Guidelines Committee identified competing interest on the basis of self-reporting. The Guidelines Committee of the Japan Society for Endoscopic Surgery shall serve as the core organization tasked to revise these guidelines in 5 years in principle. The articles requiring prompt revision shall be addressed by posting such revisions on the website. Composition of committees within the Guidelines Committee of the Japan Society for Endoscopic Surgery President Seigo Kitano Oita University Guidelines Committee of the Japan Society for Endoscopic Surgery Chairman (governor in charge) Yoshiharu Sakai Division of Gastrointestinal Surgery, Department of Surgery, Kyoto University Hospital Vice chairman Tadashi Matsuda Department of Urology and Andrology, Kansai Medical University Committee members Special adviser Working group members Esophagus Committee member Cooperation Committee members Evaluation Committee members Collaborators Stomach Committee member Cooperation Committee members Evaluation Committee member Liver Committee member Cooperation Committee members Evaluation Committee member Pancreas and Spleen Committee member Cooperation Committee members Evaluation Committee member Collaborators Large intestine Committee member Cooperation Committee members Evaluation Committee members Gallbladder and common bile duct Committee member Cooperation Committee members Evaluation Committee member Breast, thyroid and parathyroid Committee members Cooperation Committee members Evaluation Committee member Hernia Committee member Cooperation Committee members Evaluation Committee members Pediatric surgery Committee members Cooperation Committee members Evaluation Committee members Collaborators We asked the following members to perform an independent review of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II criteria (Table 1): Dr Satoru Shikata (director, Mie Prefectural Ichishi Hospital) and Dr Eishu Nango (chief physician, Department of General Medicine, Tokyo-kita Medical Center, Japan Association for Development of Community Medicine). No detailed strategy is provided for evidence search. The literature search covered the period from 1990 to 2012, and two to six key words were selected for each clinical question. However, no information is provided on which databases were consulted or whether there were language limitations. Also, there is no information regarding whether unpublished literature was searched (e.g. through manual searches, by contacting researchers). Levels of evidence were determined based on the study designs of the articles retrieved. However, the body of evidence was not examined in terms of their levels. The process used for formulating the recommendations is unclear. Ideally, any stakeholders, including general practitioners, patient representatives, and methodology experts, should participate in the formulation of the final recommendations. Search terms, strategy, and searched sources require explicit identification. The guidelines lack descriptions of inclusion criteria for the evidence, assessment of the risk of bias for individual studies, and evaluation of the body of evidence. The formulation process for recommendations is ambiguous. There is no indication whether health benefits, side-effects, and risks have been taken into consideration. It is preferable to provide tools to assist in the effective use of the guidelines (e.g. a summary table and document, computer support). Monitoring should be undertaken for the effective implementation of the practice guidelines. Measurement criteria for such monitoring should be listed as well. Explicit statements regarding conflicts of interest, including types and contents of the conflicts, are required. For the next revision, statements 2 and 7 will be placed shortly on the website.
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Sakai et al. (2015) studied this question.