Int J Colorectal Dis (2014) 29:863–875 DOI 10.1007/s00384-014-1887-x

ORIGINAL ARTICLE

Clinical competence in the surgery of rectal cancer: the Italian Consensus Conference Piccoli Micaela & Agresta Ferdinando & Trapani Vincenzo & Nigro Casimiro & Pende Vito & Campanile Fabio Cesare & Vettoretto Nereo & Belluco Enrico & Bianchi Pietro Paolo & Cavaliere Davide & Ferulano Giuseppe & La Torre Filippo & Lirici Marco Maria & Rea Roberto & Ricco Gianni & Orsenigo Elena & Barlera Simona & Lettieri Emanuele & Romano Giovanni Maria & on behalf of The Italian Surgical Societies Working Group

Accepted: 23 April 2014 / Published online: 13 May 2014 # Springer-Verlag Berlin Heidelberg 2014

Abstract Background and aim The literature continues to emphasize the advantages of treating patients in “high volume” units by “expert” surgeons, but there is no agreed definition of what is meant by either term. In September 2012, a Consensus

Conference on Clinical Competence was organized in Rome as part of the meeting of the National Congress of Italian Surgery (I Congresso Nazionale della Chirurgia Italiana: Unità e valore della chirurgia italiana). The aims were to provide a definition of “expert surgeon” and “high-volume

P. Micaela : T. Vincenzo Department of General and Emergency Surgery, NOCSAE, Modena, Italy

F. Giuseppe General and Minimally Invasive Surgery, University Department of Public Health University of Naples “Federico II”, Naples, Italy

A. Ferdinando (*) UOC di Chirurgia Generale, Presidio Ospedaliero di Adria (RO), ULSS 19 del Veneto, Adria, RO, Italy e-mail: [email protected]

L. T. Filippo Emergency Surgical Department at Policlinico “Umberto I”, “La Sapienza” University of Rome, Rome, Italy

N. Casimiro General Surgery Unit, University of Rome Tor Vergata, Viale Oxford, 81, 00133 Rome, Italy

L. M. Maria “San Giovanni” Hospital, Rome, Italy

P. Vito Department of Surgery Minimally Invasive Laparoscopic and Robotic Surgery Unit, San Giovanni Addolorata Hospital, Rome, Italy C. Fabio Cesare Surgical Division, San Giovanni Decollato Andosilla Hospital (VT), Civita Castellana, Italy V. Nereo Laparoscopic Surgical Unit, M.Mellini Hospital, Chiari, BS, Italy B. Enrico Surgery Unit, Monselice Hospital, PD ULSS, Veneto, Italy

R. Roberto U.O. Chirurgia Generale e Oncologica, Clinica Mediterranea, Naples, Italy R. Gianni U.O. Malattie dell’Apparatro Digerente, Casa di Cura Villa del Sole, Salerno, Italy O. Elena Department of Surgery at the Scientific Institute “San Raffaele”, “Vita-Salute San Raffaele” University, Milan, Italy B. Simona Laboratory of Medical Statistics, Department of Cardiovascular Research, IRCCS MARIO NEGRIO, Milan, Italy

B. P. Paolo Minimally-Invasive Surgery Unit, European Institute of Oncology, via Ripamonti 435, 20141 Milan, Italy

L. Emanuele Health Technology Assessment, Politecnico of Barlera, Milan, Italy

C. Davide Unit of Oncological Surgery and Advanced Therapies, “Morgagni-Pierantoni” Hospital—AUSL Forlì, Forlì, Italy

R. G. Maria Department G.I. Oncology, National Cancer Institute and “G. Pascale”, Naples, Italy

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facility” in rectal cancer surgery and to assess their influence on patient outcome. Method An Organizing Committee (OC), a Scientific Committee (SC), a Group of Experts (E) and a Panel/Jury (P) were set up for the conduct of the Consensus Conference. Review of the literature focused on three main questions including training, “measuring” of quality and to what extent hospital and surgeon volume affects sphincter-preserving procedures, local recurrence, 30-day morbidity and mortality, survival, function, choice of laparoscopic approach and the choice of transanal endoscopic microsurgery (TEM). Results and conclusion The difficulties encountered in defining competence in rectal surgery arise from the great heterogeneity of the parameters described in the literature to quantify it. Acquisition of data is difficult as many articles were published many years ago. Even with a focus on surgeon and hospital volume, it is difficult to define their role owing to the variability and the quality of the relevant studies. Keywords Clinical competence . Guidelines . Rectal cancer . Quality of life . Surgery

Introduction Although a volume/outcome relationship exists for several cancer operations [1–3], its application to rectal cancer surgery is uncertain. It is not known whether hospital, surgeon or oncologist volume is the most important predictor of outcome [4]. Although the literature continues to emphasize the advantages of treating patients in “high volume” units by “expert” surgeons, there is no agreed definition of either of these terms. A Consensus Conference on Clinical Competence in the surgery of rectal cancer was therefore established, and this took place on 24–25 September 2012 in Rome as part of the meeting of the National Congress of Italian Surgery. Its aims were to define the terms “expert surgeon” and “high-volume facility” in rectal cancer surgery and to assess their impact on patient outcome. The literature of the last 10 years was reviewed, and this was supplemented by opinions of authoritative Italian surgeons. The literature review focused on three main questions: 1. To what extent does hospital/surgeon volume affect the following variables? (a) (b) (c) (d) (e) (f)

Sphincter-preserving procedures Local recurrence 30-day morbidity and mortality Survival Function Choice of laparoscopic approach

(g) Choice of transanal approach (transanal endoscopic microsurgery (TEM)) 2. Which training path allows the surgeon to be defined as an expert in laparoscopic and/or robotic surgery? 3. How can “quality” be measured?

Method The Consensus Conference (CC) was organized in compliance with the recommendations included in the methodological manual developed by ISS (Istituto Superiore di Sanità, Italian National Institute of Health) (http://www.snlg-iss.it/ manuale_metodologico_consensus). An Organizing Committee (OC), a Scientific Committee (SC), a Group of Experts (E) and a Panel/Jury (P) were established. The SC was appointed by the OC, to include the most prominent Italian surgical associations (Italian Surgical Societies Working Group, see Appendix): ACOI (Associazione Chirurghi Ospedalieri Italiani), SIC (Società Italiana di Chirurgia), SICE (Società Italiana di Chirurgia Endoscopica), ACS—Italian Chapter (American College of Surgeons), CRSA (Clinical Robotic Surgery Association), ISSE (Società Italiana Endoscopia di Area Chirurgica), SICCR (Società Italiana di Chirurgia ColoRettale), SICOP (Società Italiana di Chirurgia nell'Ospedalità Privata), SIFIPAC (Società Italiana di Fisiopatologia Chirurgica), SIUCP (Società Italiana Unitaria di ColonProctologia), SPIGC (Società Italiana Polispecialistica Dei Giovani Chirurghi) and with the participation of the Foundation “Chirurgo e Cittadino” and of the study group “Medicina e Legalità”.

Literature search The initial literature search was performed through PubMed using the following keywords: volume, hospital, surgeon, load, colon and rectal surgery, clinical competence, quality of life, quality assurance, education, skill, experience. After identifying the main issues for discussion, a more focused search was initiated using the default “AND” to combine the above listed keywords with specific keywords including local recurrence, prognosis, bowel function, sexual dysfunction, bladder dysfunction, TME (total mesorectal excision), LAR (low anterior resection), robotic assisted, laparoscopy, training, learning curve, resection margin, margin circumferential, and longitudinal margin. The only filters used were English and only publications from 1991 to 2011 were included. Two independent observers (members of the SC) analysed the abstracts of all articles identified to obtain the full papers for those selected. A third observer was called in as an arbitrator in cases of difference between the two main

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observers. Duplicated studies were removed [5]. At the end of the process, 143 articles were extracted in “full text” and divided by topic, which formed the starting reference pool.

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hospital caseload plays an important role in quality, but it is unclear which of the two variables exerts the greater effect: surgeon or hospital or both. Local recurrence

Reports by the Experts 1. To what extent does hospital volume/surgeon volume affect the following variables? Sphincter-preserving procedures Abdominoperineal resection (APR) of the rectum was considered to be the standard procedure for nearly all rectal cancers. From 1980, the notion that not rectal malignancies should be submitted to APR began to be established (LE 3) [6–8]. The improved understanding of pelvic anatomy, rectal physiology and tumour biology in combination with surgical and technical advances has turned sphincter-preserving (SSP) procedures into safe and effective procedures. The maintenance of anal function has improved the quality of life of patients. This has resulted in an increase of SSP with a reduction of APR. A meta-analysis of 11 studies [9] showed that patients treated by surgeons with a high volume of rectal resections run a much lower risk of having a permanent stoma or an APR compared with those treated by low-volume surgeons. Many studies identify APR rate as a quality indicator, but case series differ and importantly the distance between the lower border of the tumour and the anal margin is rarely given. The Intergroup 0114 study [10] is an exception, in which the results are based on the height of the tumour in the rectum (LE 2). Another important meta-analysis [11] (LE 3) shows a positive correlation between hospital volume and SSP rate, and also postoperative mortality. In the meta-analysis by Intergroup 0114 [10], most studies assessing the impact of volume on SSP shows a positive correlation between both variables. Another major systematic review [12] (LE 3) concludes that the rate of permanent colostomy formation is lower in highvolume hospitals. It should, however, be noted that there is considerable heterogeneity in the literature regarding the parameters used to define the number of procedures defining a given hospital or surgeon as “high or low volume”. Data are often collected at different points in time and are frequently rendered obsolete due to the long time span of data collection. Consequently, the procedures used have been changing over time, due to the refinement of surgical techniques, especially TME (total mesorectal excision). The results of these studies show that both surgeon and hospital volume produce a positive effect on the quality of surgery and in particular on the rate of sphincter-preserving resections (LE 2–3) (version 2011 of Oxford Centre for Evidence-based Medicine Levels of Evidence). The size of

The search on local recurrence (LR) after surgery for rectal cancer was carried out separately for hospital and surgeon volume. Hospital volume Ten studies (LE 2–3) analysed the correlation between hospital volume and LR incidence in the 5 years following the procedure [10, 11, 13–19] (LE 3). The metaanalysis of Archampong et al. [20] published in 2012 showed that among 3,870 patients operated for rectal cancer, the risk of local recurrence at 5 years was significantly lower (hazard ratio (HR)=0.70) for hospitals with the highest caseloads defined as 17 or more cases/year. This advantage showed, however, a non-significant change in value for case mix adjusted data (HR=0.77, 95 % CI 0.51–1.16). According to the recent observation of Iversen [21] (LE 3), “hospital volume” is a proxy for other major surgery-unrelated factors and also structural and organizational factors, such as intensive care quality, availability of high-level multidisciplinary services and qualified nursing. Surgeon volume Seven studies, including two independent reviews, (LE 2–3), analysed the correlation between “surgeon volume” and the incidence of LR at 5 years. They show a statistically significant fall in local recurrence rate (HR=0.42– 0.56) for surgeons with a greater volume of rectal cancer procedures, but the threshold beyond which a surgeon should be considered as “high volume” was not clearly defined and the numbers varied between 10 and 21 cases per year [4, 11, 13, 17, 19, 21, 22]. Surgeon specialization A review of the literature (LE 3) found the surgeon’s “specialization” in colorectal surgery was an independent prognostic factor for 5-year local recurrence. However, “specialization” is not clearly defined and is sometimes described as a surgeon’s special commitment to the study of rectal cancer pathology [22] (LE 3), while in other cases, it is understood as membership of a scientific association with a special focus on this pathology [23, 24]. In other papers, a surgeon’s extensive experience in the treatment of this pathology qualifies him or her to be a “specialist” [17] (LE 2). However defined, “specialization” in colorectal surgery is significantly correlated with a lower incidence (HR=0.55) of 5-year local recurrence [20] (LE 3). Further studies are needed to assess the impact of all these prognostic, technical and management factors, since the evidence of significant benefit in favour of higher volume surgeons/hospitals could result in the strategic decision to

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concentrate this disease in large hospitals equipped with specialist surgeons, sophisticated technology and more extensive health care services, taking it away from smaller hospitals, although the latter may be easier to reach for many patients. 30-day morbidity and mortality rates The literature is very heterogeneous and mainly includes observational studies [16, 17, 22, 25–27], with varying results. In 2006, a systematic review considered all studies published from 1992 to June 2004 and selected 35 studies (prospective, retrospective and registry studies) to assess the short-term outcome (LE 2). Only five of these however were specifically focused on rectal cancer, and there was no correlation between hospital volume and 30-day morbidity. In particular, no correlation was demonstrated between high hospital volume and the incidence of anastomotic dehiscence [28]. The correlation between morbidity and surgeon procedure volume was also not statistically significant [4, 19, 22, 23, 29, 30], which may be due to the loss of important information on postoperative complications during data collection [10]. It could also be explained by the lack of standardization of the surgical technique [31]. Another reason for the difficulties in interpreting the relationship of volume to morbidity in rectal cancer surgery seems to be due to patient-related factors including gender, age, tumour staging at diagnosis and comorbidity. All are independent prognostic factors, adversely affecting the postoperative morbidity [32], and thus, even in the case of high-volume hospitals and specialist surgeons, it is difficult to eliminate the risk of the postoperative complications occurring in high-risk patients [33, 34]. More prospective studies are necessary to define a correlation between morbidity, surgeon procedure volume and hospital caseload [13]. Survival The relationship between hospital volume and outcome in cancer patients has long been suggested by reviews [15], but a large caseload is not predictive of positive results of treatment and postoperative course [35, 36]. The analysis of overall survival in rectal cancer, in connection with the parameters of hospital volume and surgeon volume, is basically complex and controversial [11, 34] because this pathology is increasingly addressed by a multidisciplinary approach and the applicable therapeutic protocols are constantly evolving. Excellent tumour regression, for instance, has been observed in many cases after neoadjuvant therapy, but difficulties in its standardization are making many surgeons choose wait and watch with unknown effect on long-term survival [37, 38]. There is a broad disagreement in the definition of volume, both “hospital” and “surgeon” [39, 40].

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Hospital volume The data from high-volume hospitals seem to be the best, although the treatment and care processes producing this result require further study (LE 3–4) [39]. Also, in smaller volume hospitals, surgeons with sub-specialty training obtain the same results as in high-volume hospitals [40, 41]. Rogers et al. [42] (28,644 patients) and Hodgson et al. [39] (7,257 patients) reported a uniform distribution, even though only a quarter of patients were treated in facilities with a high caseload (LE 3). Friese et al. observed that patient characteristics vary according to the type of hospital [43]. Rogers et al. reported that the best performance obtained in high-volume facilities coincided with procedures carried out on less complicated patients (with less comorbidity and smaller tumour volume) [42]. Karanicolas et al. confirmed that lower volume facilities are characterized by a greater concentration of more critical and debilitated patients, which results in lesser protocol compliance and worse final outcome [34]. Surgeon volume The incidence on survival of the value of “surgeon volume” is viewed with a greater degree of agreement (LE 2a) [4]. In the assessment of surgeon volume, no weighting of the influence of the specialty of colorectal surgery has been taken into account [38]. Extensive oncological surgery reviews conclude that the surgeon’s specialization (residential courses, specializations, personal interest) and expertise (years of practice, improvements) are more crucial than the caseload [44, 45]. Function Although the primary aim of surgery is survival through R0 resection, there is increasing appreciation of the functional implications produced in the patient’s sex life, urinary function, continence, self-esteem and self-image. Indeed, quality of life (QoL) is a multidimensional notion involving rational, emotional and relational spheres. It is quite normal for patients diagnosed with rectal cancer to be anxious and depressed, but what is less obvious is the lack of selfconfidence, the feeling of insecurity in social and sexual life, anxiety of the sexual impairment following surgery and the altered sense of body image with a stoma (LE 4) [46]. Even though the objective quantification of function may be difficult, the literature provides many internationally validated tools for the dedicated measurement of function including through questionnaires of the impact of surgery on quality of life [47–49] (LE 1). Multimodal treatments have become standard, and although neoadjuvant radiotherapy affects continence and sexual function, there is evidence that it increases the chance of a sphincter-saving procedure [49–52] (LE 1).

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TME has greatly reduced the rate of local recurrence. The price to be paid for this, however, is a rate of 5 to 70 % of urinary and sexual nerve-induced dysfunction (LE 4 [53, 54], LE 3 [55–59]). Laparoscopic technique can bring a substantial benefit, thanks to image magnification made possible by the new instruments which allow a better view of the nerves during mesorectal dissection (LE 3) [54, 57, 58]. Many patients complain of massive discharge, sometimes accompanied by soiling or even full faecal incontinence, especially if the rectal ampulla has been removed. These episodes can be treated by medical therapy (LE 3) [60]. The construction of a J-pouch (6-cm limb) from the descending colon or a side-to-end colorectal anastomosis may improve the results of conventional anterior resection or after coloanal anastomosis [61–63] (LE 1). Side-to-end colorectal anastomosis appears to be less prone to dehiscence than the traditional KG type, possibly due to better perfusion of the colonic segment [64–66] (LE 4). A recent meta-analysis [67] showed that, despite reported complications [68, 69], a protective ileostomy reduces morbidity and mortality of low rectal resection (LE 2). In conclusion, although many authors are still skeptical towards adopting volume as a parameter to assess quality, a high surgeon volume in conjunction with good training and specialization [4, 15, 70, 71] appears to be important in achieving better function in units adopting a multidisciplinary approach to rectal surgery (LE 2) [43, 72, 73]. Choice of the laparoscopic approach Laparoscopic colorectal surgery dates back to 1991 [74, 75], after the introduction of laparoscopic cholecystectomy. The slight delay was due in part to concern about the safety of laparoscopy in oncology [74, 75], training difficulties related to the complexity of this form of surgery [76] and the increased cost. For these reasons, laparoscopy was used only in selected cases and in a small number of hospitals [77, 78]. While waiting for the ongoing North American and European randomized controlled trials comparing laparoscopy with laparotomy in rectal cancer surgery [79, 80], current data suggest that laparoscopy gives as good cancer-specific results in the hands of trained surgeons [81, 82] (LE 1). There are no studies which compare hospital/surgeon volume with open and laparoscopic surgery, and there is no significant correlation between total caseload and the percentage of cases treated laparoscopically. However, it is unanimously recognized that rectal surgery is technically demanding, but the more so if performed laparoscopically, which requires a longer and steeper learning curve [83–85] (LE 3). In comparative studies comparing open and laparoscopic surgery, the choice of approach, if mentioned at all, is seldom

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based on the surgeon’s laparoscopic expertise [84]. It may be based on other factors, which broadly include the following: – Patient’s preference [86] – Surgeon’s preference [85] – Patient’s body habitus – Site and size of tumour [87] – Palpable mass found at examination under general anaesthesia [88] – Availability of a suitably equipped operating theatre [89] – Tumour invading other adjacent organs or concomitant colonic disease requiring extended resection or liver metastases requiring synchronous resection [90] There are conflicting results when laparoscopic colorectal resection is carried out in a high-volume compared with a lowvolume facility. For colonic surgery, there is no statistical difference in conversion rate between the groups according to Bennet et al. [89] who performed a prospective analysis of 1,194 laparoscopic-assisted colectomies in the USA. Conversely, in the European prospective multicenter COLOR (Colon Cancer Laparoscopic or Open Resection) study [90], the conversion rate was found to be 24 % for low-volume (10 cases/ year). Both studies reported a lower complication rate in patients treated in a high-volume facility. With regard to rectal laparoscopic surgery, however, the operation time is the only parameter directly recognized to be correlated with experience, being inversely related to the surgeon’s skill level [91, 92]. There is also a relationship between hospital/surgeon volume and conversion rate to laparotomy, anastomotic leakage, general complications and reoperation. Some authors maintain that conversion and complications decrease with experience, while others believe that general complications, anastomotic leakage and reoperations increase with the increasing complexity of the procedures. These observations reinforce the assumption that as the surgeon’s and the operating team’s experience grow, the procedures they perform improve and so do the results obtained. The price paid, however, is an overall global increase of complications directly related to the complexity of the procedure. Among laparoscopic colorectal procedures, low anterior resection and restorative proctocolectomy with ileal reservoir have the highest level of technical difficulty [93, 94] (LE 4). The transanal approach (TEM) The transanal approach includes one of the following techniques [95–99]: & Conventional—endoanal submucosal resection (lesions of the distal rectum/full-thickness resections) & ETAR—endoscopic transanal resection by means of a resectoscope (lesions of the mid- and distal rectum)

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& & &

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MITAS—minimal invasive transanal surgery (lesions of the mid- and distal rectum/partial-thickness and fullthickness mucosectomy) TEM—transanal endoscopic microsurgery (lesions of the proximal and distal rectum/full-thickness/circumferential resections) TEVA/TAMIS—transanal endoscopic video-assisted excision and transanal minimally invasive surgery (SILS, proximal and distal rectum/full thickness)

A transanal endoscopic procedure [100] includes the following: & EMR—endoscopic mucosal resection (proximal and distal rectum/mucosectomy) Some of these methods are more suitable for lesions in the distal rectum and others for those in the proximal rectum. Only a few permit full-thickness excisions of the rectal wall, and TEM is the only transanal procedure which allows circumferential resection of the rectal wall. Transanal endoscopic microsurgery (TEM) gives good results for large villous adenoma, both in the short term and for distant recurrences [101] (LE 2) and is the most indicated surgical procedure in lesions of the proximal rectum [102] (LE 4), while it is controversial that TEM may represent the transanal surgical procedure of choice for distal rectum lesions [100, 103] (LE 2). TEM seems to be the most suitable transanal method for rectal lesions with suspected early invasion and staged as T1 with minimal penetration of the submucosa [104–108] (LE 3). Although it is not possible to correlate this approach to hospital/surgeon volume, there is some evidence that: & TEM needs a structured training and its clinical use is characterized by a long learning curve [109–111] (LE 4). & The surgeon’s level of expertise is related to the procedure time, complications and short- and long-term outcomes [109, 112] (LE 4). The incidence of complications is also correlated to the site of the tumour [113] (LE 4). There is a correlation between the surgeon’s willingness to adopt endoluminal therapies after adequate training, rather than conventional treatment, but this willingness for change was found to be statistically significant for upper rather than lower GI procedures including TEM and EMR [111] (LE 4). The choice of the transanal approach for early rectal cancer is influenced by various factors including the following: 1. The difficulty of reliable tumour staging [114–116] (Level of Evidence 3). 2. The biological behaviour and histology of the tumour [115–119] (Level of Evidence 3). There is a correlation between the depth of submucosal invasion (SM1–3) and

the risk of lymph node involvement (0–3 % SM1; 20– 25 % SM3). 3. Intramural vascular invasion. This was found to be the only significant predictor of survival in patients not undergoing neoadjuvant therapy. 4. T-stage. The risk of recurrence after local excision of T1 and T2 tumours is substantial: two thirds of the patients with recurrence develop local recurrence which could be due to an inadequate resection [118] and the incidence of recurrence in patients with early rectal cancer may be higher than reported [119]. The long-term outcome after local treatment for early rectal cancer has not yet been reported on a large scale [105, 108, 115] (Level of Evidence 2), and the role of TEM is still controversial. The long-term results of TEM are limited, as they are based on one small randomized controlled trial [105]. There is however increasing evidence that local resection should be reserved for some very well selected patient niches, such as patients with large adenomas of the proximal rectum, patients with low-risk T1 rectal carcinomas and for cases of palliation therapy for more advanced malignancies [120, 121]. The use of local surgery for T2 and T1 carcinomas requires multicentre prospective randomized trials to compare radical and local surgery, with or without adjuvant therapy. The lack of data and the heterogeneous character of the factors affecting the potential choice of local treatment and of the transanal approach to rectal surgery, especially in the case of malignancy, reflect the limitations of the current literature and, consequently, make it impossible to assess the role played by hospital/surgeon volume. 2. Which training path allows the surgeon to be defined as an expert in laparoscopic and/or robotic surgery? There is little information on the training to be followed in rectal laparoscopic surgery, as there are no controlled randomized studies. Furthermore, there is no agreement on the criteria needed to assess the surgeon’s learning curve, which makes it difficult to compare the various studies. In the studies, the learning curve is assessed differently, some are based on the reduction of operating time, some on the number of conversions to open surgery, yet others on the number of complications and local recurrences [122, 123] (LE 3b). Most studies address colonic and rectal surgery together and assess the learning curve of surgeons already skilled in minimally invasive colorectal surgery [122, 123] (LE 3b). The CLASICC trial was the first randomized comparative trial on laparoscopy versus open surgery to consider also rectal resections. Surgeons were required to have performed 20 laparoscopic colorectal procedures. The conversion rate dropped from 38 % in the first year to 16 % in the sixth year of recruitment (LE 1b) [124]. The COREAN study compared open

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versus laparoscopic surgery of the mid- and lower rectum after neoadjuvant radio/chemotherapeutic treatment. Seven surgeons were enrolled with a median experience of 75 procedures each, and their video-recorded procedures were assessed by a panel of experts. Two (1.2 %) procedures of 170 were converted to open surgery in this study (LE 1b) [125]. Considering the reduction in operating time as a parameter to assess the learning process in a series of expert surgeons, the first fall occurred between 49 and 90 cases [122, 123, 126, 127] (LE 2c), even though some studies reported higher numbers. In the study by Pendlimari et al. [128], the significant change in operating time was observed after 105 cases of hand-assisted colorectal surgery (LE 3b). As to the quality assessment of the training path, the presence of a mentor throughout the learning curve prevents its negative impact on the clinical outcome and on the oncological safety of the laparoscopic procedure (LE 2c) [123, 129, 130]. Specifically, the presence of an expert tutor results in the reduction of operating time after 40–60 procedures. There are no significant differences in the results achieved by the expert surgeon, throughout the training period, as far as conversion to open surgery, postoperative complications and oncological radicality are concerned [131, 132] (LE 2c). The study by Hemandas et al. [133] considers modular training, requiring the trainee to perform predefined and increasingly difficult procedure modules, under the guidance of an expert surgeon. Ninety-seven percent of the procedures were completed by the minimally invasive route without significant changes in the clinical outcome (LE 2c). The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and American Society of Colon and Rectal Surgeons (ASCRS) set up a focus group to analyse the training path for colonic laparoscopic resection. As far as the rectum is concerned, however, due to the lack of high levels of evidence, only a recommendation has been issued advising that laparoscopic resection of the rectum should be restricted to facilities specialized in colorectal and minimally invasive surgery (http:// www.fascrs.org/physicians/position_statements/laparoscopic_ proctectomy, http://www.sages.org/publication/id/32/). The European Association for Endoscopic Surgeons (EAES) published the results of a consensus conference on the guidelines for rectal laparoscopic surgery, which does not analyse the training process. It does, however, recommend that the procedures should be performed by expert surgeons, in specialty facilities, on selected patients and with the exclusion of advanced stages [80]. The use of simulation training helps to improve the dexterity in the performance of intracorporeal suturing and knot tying [134, 135] (LE 3b). Simulation systems include direct, virtual or computer-enhanced training with tactile feedback. Although most users prefer tactile feedback systems over other fully virtual devices, the randomized study by Kanumuri et al. [134] (LE 2b) reports that no differences were found between both systems in the improvement of proficiency and that equal

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results were achieved. Robotic simulators allow novices to complete exercises faster and with fewer mistakes, compared with other traditional laparoscopic tools [136, 137] (LE 3b). The study by Hogle et al. [138] (LE 2b) considers three different studies, two of which randomized, and assesses the impact of simulator-assisted training on the subsequent reduction of operating time. The study does not report any improvement in operating proficiency in the simulator-assisted group. The studies on robotic-assisted rectal surgery consider only cases treated by surgeons already experienced in minimally invasive rectal surgery. The comparative studies versus laparoscopic surgery show that the conversion rate to open resection is statistically lower (LE 3b) [139, 140]. The study by Akmal et al. considers the operating time on two consecutive groups of 40 patients and shows no differences between both groups, concluding that the robotic-assisted technique mitigates the learning curve in the total mesorectal excision (LE 3b) [141]. The learning curve is the object of several studies, which however have low evidence level and are not comparable. To draw any final conclusion, randomized controlled studies will be necessary, providing comparison between the various teaching/learning modes. The hypothesis that robotic assistance can decrease the learning time of minimally invasive rectal surgery shall need to be proven by further comparative studies compared with the standard laparoscopic technique. 3. How can quality be measured? Many rectal surgery studies show improved results in units with a high referral rate (hospital volume) [142] and with surgeons who are expert in this type of surgery (surgeon volume) [9] (LE 2). Many studies show that there is a lack of consistency among hospitals in treatment, contrary to the principle stated in all National Health Plans that Uniform Health Care Levels should be provided to all citizens [143] (LE 2). Assuming that the quality of the surgical teams and the number of patients requiring treatment remain the same, it is questionable whether any hospital will be able to guarantee high-quality standards of treatment to rectal cancer patients. In 2007, the German working group “Workflow Rectal Cancer II” published 19 quality indicators for the treatment of rectal cancer, with 36 Quality Goals to be used in specialized units [144] (LE 4). It seems to be the case that some quality indicators are strongly affected by the availability of technological and organizational tools and of an efficient multidisciplinary team. In particular, results are determined by the following: 1. Correct identification of lesions and staging, further improved by high-resolution (HR) and high-definition (HD) endoscopy, enhanced by chromoendoscopy (CE) with optical filters [145] (LE 1) (narrow band imaging (NBI)) [146] or by electronic filters (FICE, I-Scan) [147] (LE 3).

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2. Transrectal endoscopic ultrasound staging, which allows a good degree of accuracy in differentiating intramucosal lesions which can be treated radically with endoscopic resection, from initial submucosal invasive lesions which, having a risk of locoregional lymph node metastasis in about 6–12 % of cases, require surgical resection with lymphadenectomy with curative intent [148, 149] (LE 3–4). 3. TC MS, PET-TC and RMN staging, which can detect both locoregional lymph nodes and any distant metastasis [150–152] (LE 4). The outcome quality indicators seem to be affected by the availability of advanced technology and of specialized professionals able to detect recurrence at an early stage, so that a salvage procedure can be carried out or therapy such as chemotherapy or radiotherapy can be administered [153–159] (LE 2–4). It is clear that the results of the studies analysed suggest that rectal cancer surgery has benefit when performed in hospitals which attract a high volume of patients with high technological and organizational facilities to foster high-quality safe performance.

Conclusions by the Panel As is clear from the report by the Experts, the available scientific evidence comes almost exclusively from prospective observational studies (cohort studies) or retrospective (case-control) studies. This reinforced the belief of the Organizing Committee and the Scientific Committee belief that the CC is the correct methodological tool to address the issues at hand. The first true conclusion by the CC was that in the light of the evidence in the literature, it is difficult for the Panel/Jury to draw any conclusions regarding the real value of surgeon and/or hospital volume as far as outcome is concerned. Recommendation 1 Based on the analysis of the literature, the influence of surgeon and hospital volume on the results of rectal cancer surgery remains uncertain. The first difficulty encountered when trying to define clinical competence in rectal surgery arises directly from the analysis of the relevant literature, where heterogeneous parameters are used to quantify it. Obtaining the necessary data is as difficult, as quite often the period from which the data are derived is over many years and often out of date. The sources of data are heterogeneous and not comparable, as they stem from different Italian health care settings. Some of the evidence, however, is characterized by a special focus on surgeon volume and experience and on hospital volume. Even for

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these two parameters, an objective judgment is difficult, owing to the variability and the quality of the studies. Recommendation 2 The Panel acknowledges surgeon volume/experience as a factor positively affecting outcome (moderate recommendation). The literature does not provide a statement of the numbers of rectal cancer operations required to define a “high” or “low” volume surgeon, nor does it clarify the meaning of the term “specialist”. Nevertheless, the variable “surgeon volume”, understood as specific expertise, is considered by the literature to be an important positive prognostic factor. Recommendation 3 Although hospital volume seems to affect the outcome positively, the Panel believes that its predictive value is limited, being a proxy of other context variables (strong recommendation). Hospital volume appears to be a proxy for other (technological and/or organizational) variables, which account for the positive relationship between volume and outcome. As these variables and their impact upon outcome have not been clearly identified, based on the currently available evidence, it is difficult to interpret the positive impact of hospital volume in rectal surgery. Recommendation 4 The Panel recognizes the diagnostic and therapeutic multidisciplinary approach achievable through a locally networked organization, as a factor producing a positive impact on the outcome (strong recommendation). The approach to rectal malignancy is increasingly multidisciplinary, with evolving diagnostic and therapeutic protocols. Multimodal treatment produces an obvious positive influence not only on outcome but also on therapeutic strategy. Recommendation 5 The Panel acknowledges that clinical competence cannot be summarized by the simple parameters of surgeon/ hospital volume and that it needs suitable quality indicators (strong recommendation). No present definite and final conclusions can be drawn in the light of the available scientific evidence. The consequences on health care policy decisions should be considered, especially taking into account the patient as a factor with independent weighting and all other variables. Many quality

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indicators are analysed in the literature also in connection with surgeon and hospital volume, but there are no definite data that permit a judgment of their true significance. Recommendation 6 The Panel deems it necessary to establish a working group, able to detect and assess the quality indicators suitable to identify expert surgeons and assess new technologies (strong recommendation) The task of such a Panel would be to express judgment based on the evidence available in the literature. Another task, just as important, is to identify any uncertain areas of topical issues, where there is too little evidence to generate debate. More important still would be the task of suggesting the type of research and the relevant studies that need to be conducted to produce more evidence. To this aim, the Panel feels it necessary that over the next few years, work should be focused on the study of indicators of quality and on the design of robust studies.

General methodological conclusive considerations The lack of high levels of evidence on the matters discussed by the CC should stimulate reflection. There is, however, concern that in the next few years no significant evidence will be spontaneously produced and it would not be ethical to perform a randomized clinical trial in which patients would be assigned to a high- or low-volume hospital/surgeon. It is of utmost importance to establish a prospective cohort study and registry stating the details of the surgical resources, whereby information on quality indicators can be collected in the form of standardized and shared criteria. Acknowledgments The authors thank Mrs Janette Hanney from the UK for the linguistic review of the manuscript. Disclosures The authors, Piccoli Micaela, Agresta Ferdinando, Trapani Vincenzo, Nigro Casimiro, Pende Vito, Campanile Fabio Cesare, Vettoretto Nereo, Belluco Enrico, Bianchi Pietro Paolo, Cavaliere Davide, Ferulano Giuseppe, La Torre Filippo, Lirici Marco Maria, Rea Roberto, Ricco Gianni, Orsenigo Elena, Barlera Simona, Lettieri Emanuele and Romano Giovanni Maria, and all the members of The Italian Surgical Societies Working Group have no conflicts of interest or financial ties to disclose.

Appendix Membership of the SC Co-coordinators: Ferdinando Agresta, Micaela Piccoli Members: Simona Barlera (statistician), Stefano Bartoli, Fabio Cesare Campanile, Emanuele Lettieri (Health Technology

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Assessment), Casimiro Nigro, Vito Pende, Vincenzo Trapani, Nereo Vettoretto Group of Experts Enrico Belluco, Pietro Paolo Bianchi, Davide Cavaliere, Giuseppe Ferulano, Filippo La Torre, Marco Maria Lirici, Roberto Rea, Gianni Ricco, Elena Orsenigo The Italian Surgical Societies Working Group: Panel/Jury Carlo Augusto Sartori—Jury President, Antonio Mele—Jury Co-president (Istituto Superiore di Sanità), Luciano Casciola, Francesco Corcione (Elected President SIC, President SICE), Annibale D’Annibale, Nicola De Manzini, Giovanni Battista Doglietto, Ermanno Leo, Emanuele Lezoche, Ignazio Marino, Gianluigi Melotti, Mario Morino, Luigi Presenti, Fernando Prete, Raffaele Pugliese, Giovanni Maria Romano, Eugenio Santoro, Giuseppe Spinoglio, Mario Trompetto

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