The Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colonproctologia) guidelines for the management of acute and chronic hemorrhoidal disease.

The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colon-Proctologia, SIUCP) on the diagnosis and management of hemorrhoidal disease, with the goal of guiding physicians in the choice of the best treatment option. A panel of experts was charged by the Board of the SIUCP to develop key questions on the main topics related to the management of hemorrhoidal disease and to perform an accurate and comprehensive literature search on each topic, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in multiple rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to PICO (patients, intervention, comparison, and outcomes) criteria, and the statements were developed adopting the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology. In cases of grade 1 hemorrhoidal prolapse, outpatient procedures including hemorrhoidal laser procedure and sclerotherapy may be considered the preferred surgical options. For grade 2 prolapse, nonexcisional procedures including outpatient treatments, hemorrhoidal artery ligation and mucopexy, laser hemorrhoidoplasty, the Rafaelo procedure, and stapled hemorrhoidopexy may represent the first-line treatment options, whereas excisional surgery may be considered in selected cases. In cases of grades 3 and 4, stapled hemorrhoidopexy and hemorrhoidectomy may represent the most effective procedures, even if, in the expert panel opinion, stapled hemorrhoidopexy represents the gold-standard treatment for grade 3 hemorrhoidal prolapse.

Rectus muscle diastasis in Italian women: determinants of disease severity, and associated disorders.

Purpose: Diastasis of rectus abdominis (DRA) refers to a separation of the rectus abdominis from the linea alba, which is common in the female population during pregnancy and in the postpartum period. The present study aimed at investigating DRA severity, risk factors and associated disorders. Methods: In the present cross-sectional study, a web-based questionnaire was addressed to the 23,000 members of the Women's Diastasis Association. The questionnaire comprised three parts, dedicated respectively to diastasis characteristics, possible risk factors, and related disorders. Faecal and urinary incontinences were assessed using the Wexner and ICIQ-SF score, respectively. Risk factors for diastasis severity (<3, 3-5, >5 cm) were evaluated by a multinomial regression model. Results: Four thousand six hundred twenty-nine women with a mean age (SD) of 39.8 (6.5) years and a median BMI of 23.7 kg/m2 (range 16.0-40.0) responded to the questionnaire. Proportion of DRA >5 cm increased from 22.8% in norm weight women to 44.0% in severely obese women, and from 10.0% in nulliparous women to 39.3% in women with >3 pregnancies. These associations were confirmed in multivariable analysis. DRA severity was associated with the risk of abdominal hernia and pelvic prolapse, whose prevalence more than doubled from women with DRA <3 cm (31.6% and 9.7%, respectively) to women with DRA >5 cm (68.2% and 20.2%). In addition, most patients reported postural pain and urinary incontinence, whose frequency increased with DRA severity. Conclusion: The present study confirmed that DRA severity increases with increasing BMI and number of pregnancies. Larger separation between rectal muscles was associated with increased risk of pain/discomfort, urinary incontinence, abdominal hernia and pelvic prolapse. Prospective studies are needed to better evaluate risk factors.

The Italian Unitary Society of Colon-proctology (SIUCP: Società Italiana Unitaria di Colonproctologia) guidelines for the management of anal fissure.

INTRODUCTION: The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (SIUCP: Società Italiana Unitaria di Colon-Proctologia) on the diagnosis and management of anal fissure, with the purpose to guide every physician in the choice of the best treatment option, according with the available literature. METHODS: A panel of experts was designed and charged by the Board of the SIUCP to develop key-questions on the main topics covering the management of anal fissure and to performe an accurate search on each topic in different databanks, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in different rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to the PICO criteria, and the statements developed adopting the GRADE methodology. CONCLUSIONS: In patients with acute anal fissure the medical therapy with dietary and behavioral norms is indicated. In the chronic phase of disease, the conservative treatment with topical 0.3% nifedipine plus 1.5% lidocaine or nitrates may represent the first-line therapy, eventually associated with ointments with film-forming, anti-inflammatory and healing properties such as Propionibacterium extract gel. In case of first-line treatment failure, the surgical strategy (internal sphincterotomy or fissurectomy with flap), may be guided by the clinical findings, eventually supported by endoanal ultrasound and anal manometry.

Minimally invasive approach to incisional hernia in elective and emergency surgery: a SICE (Italian Society of Endoscopic Surgery and new technologies) and ISHAWS (Italian Society of Hernia and Abdominal Wall Surgery) online survey.

Minimally invasive abdominal wall surgery is growing worldwide, with a constant and fast improvement of surgical techniques and surgeons' confidence in treating both primary and incisional hernias (IH). The Italian Society of Endoscopic Surgery and new technologies (SICE) and the ISHAWS (Italian Society of Hernia and Abdominal Wall Surgery) worked together to investigate state of the art in IH treatment in elective and emergency settings in Italy. An online open survey was designed, and Italian surgeons interested in abdominal wall surgery were invited to fill out a 20-point questionnaire on IH surgical procedures performed in their departments. Surgeons were asked to express their points of view on specific questions about technical and clinical variables in IH treatment. Preferred approach in elective IH surgery was minimally invasive (59.7%). Open surgery was the preferred approach in 40.3% of the responses. In emergency settings, open surgery was the preferred approach (65.4%); however, 34.5% of the involved surgeons declare to prefer the laparoscopic/endoscopic approach. Most respondents opted for conversion to open surgery in case of relevant surgical field contamination, with a non-mesh repair of abdominal wall defects. Among those that used the laparoscopic approach in the emergent setting, the majority (74%) used the size of the defect of 5 cm as a decisional cut-off. The spread of minimally invasive approaches to IH repair in emergency surgery in Italy is gaining relevance. Code-sharing through scientific societies can improve clinical practice in different departments and promote a tailored approach to IH surgery.

Minimally invasive vs. open segmental resection of the splenic flexure for cancer: a nationwide study of the Italian Society of Surgical Oncology-Colorectal Cancer Network (SICO-CNN).

BACKGROUND: Evidence on the efficacy of minimally invasive (MI) segmental resection of splenic flexure cancer (SFC) is not available, mostly due to the rarity of this tumor. This study aimed to determine the survival outcomes of MI and open treatment, and to investigate whether MI is noninferior to open procedure regarding short-term outcomes. METHODS: This nationwide retrospective cohort study included all consecutive SFC segmental resections performed in 30 referral centers between 2006 and 2016. The primary endpoint assessing efficacy was the overall survival (OS). The secondary endpoints included cancer-specific mortality (CSM), recurrence rate (RR), short-term clinical outcomes (a composite of Clavien-Dindo > 2 complications and 30-day mortality), and pathological outcomes (a composite of lymph nodes removed ≧12, and proximal and distal free resection margins length ≧ 5 cm). For these composites, a 6% noninferiority margin was chosen based on clinical relevance estimate. RESULTS: A total of 606 patients underwent either an open (208, 34.3%) or a MI (398, 65.7%) SFC segmental resection. At univariable analysis, OS and CSM were improved in the MI group (log-rank test p = 0.004 and Gray's tests p = 0.004, respectively), while recurrences were comparable (Gray's tests p = 0.434). Cox multivariable analysis did not support that OS and CSM were better in the MI group (p = 0.109 and p = 0.163, respectively). Successful pathological outcome, observed in 53.2% of open and 58.3% of MI resections, supported noninferiority (difference 5.1%; 1-sided 95%CI - 4.7% to ∞). Successful short-term clinical outcome was documented in 93.3% of Open and 93.0% of MI procedures, and supported noninferiority as well (difference - 0.3%; 1-sided 95%CI - 5.0% to ∞). CONCLUSIONS: Among patients with SFC, the minimally invasive approach met the criterion for noninferiority for postoperative complications and pathological outcomes, and was found to provide results of OS, CSM, and RR comparable to those of open resection.

Stapled fascial suture: ex vivo modeling and clinical implications.

BACKGROUND: Recently, in the field of abdominal wall repair surgery, some minimally invasive procedures introduced the use of staplers to provide a retromuscular prosthetic repair. However, to the knowledge of the authors, there are little data in the literature about the outcomes of stapled sutures adoption for midline reconstruction. This study aims to investigate the biomechanics of stapled sutures, simple (stapled), or oversewn (hybrid), in comparison with handsewn suture. From the results obtained, we tried to draw indications for their use in a clinical context. METHODS: Human cadaver fascia lata specimens, sutured (handsewn, stapled, or hybrid) or not, underwent tensile tests. The data on strength (maximal stress), ultimate strain (deformability), Young's modulus (rigidity), and dissipated specific energy (ability to absorb mechanical energy up to the breaking point) were recorded for each type of specimens and analyzed. RESULTS: Stapled and hybrid suture showed a significantly higher strength (handsewn 0.83 MPa, stapled 2.10 MPa, hybrid 2.68 MPa) and a trend toward a lower ultimate strain as compared to manual sutures (handsewn 344%, stapled 249%, hybrid 280%). Stapled and hybrid sutures had fourfold higher Young's modulus as compared to handsewn sutures (handsewn 1.779 MPa, stapled 7.374 MPa, hybrid 6.964 MPa). Handsewn and hybrid sutures showed significantly higher dissipated specific energy (handsewn 0.99 mJ-mm3, stapled 0.73 mJ-mm3, hybrid 1.35 mJ-mm3). CONCLUSION: Stapled sutures can resist high loads, but are less deformable and rigid than handsewn suture. This suggests a safer employment in case of small defects or diastasis (< W1 in accord to EHS classification), where the presumed tissutal displacement is minimal. Oversewing a stapled suture improves its efficiency, becoming crucial in case of larger defects (> W1 in accord to EHS classification) where the expected tissutal displacement is maximal. Hybrid sutures seem to be a good compromise.

Extended totally extraperitoneal Rives-Stoppa (eTEP-RS) technique for ventral hernia: initial experience of The Wall Hernia Group and a surgical technique update.

The enhanced-view extended totally extraperitoneal (eTEP) approach for ventral hernia repair is a novel surgical technique. We present the results from the initial experience with eTEP repair Rives-Stoppa (eTEP-RS) at two Italian centers, and we provide an update on this approach. Between December 2018 and July 2020, 19 patients suffering from ventral hernia were treated with the eTEP-RS. Patients' characteristics, operative details, and complications were analyzed. The median follow-up time was 16 (range 6-24) months. Thirteen (68.4%) patients with ventral incisional hernias and 6 (31.6%) with primary ventral hernia underwent an eTEP-RS procedure. The average defect area was 21 cm2 and the prosthesis's average size was 380 cm2. We registered complications in two cases (10.5%); 1 patient had an asymptomatic seroma (Clavien-Dindo grade 1), and another had intestinal obstruction on the 10th postoperative day (Clavien-Dindo grade 3B). The mean hospital stay was 3.9 (range: 2-6) days. There was no hernia recurrence. The eTEP-RS is a feasible and safe approach in ventral hernia repair with minimally invasive surgery. Further studies are needed to define patients' selection and to know long-term outcomes.

Complications and mortality in a cohort of patients undergoing emergency and elective surgery with perioperative SARS-CoV-2 infection: an Italian multicenter study. Teachings of Phase 1 to be brought in Phase 2 pandemic.

Since the beginning of the pandemic due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its related disease, coronavirus disease 2019 (COVID-19), several articles reported negative outcomes in surgery of infected patients. Aim of this study is to report results of patients with COVID-19-positive swab, in the perioperative period after surgery. Data of COVID-19-positive patients undergoing emergent or oncological surgery, were collected in a retrospective, multicenter study, which involved 20 Italian institutions. Collected parameters were age, sex, body mass index, COVID-19-related symptoms, patients' comorbidities, surgical procedure, personal protection equipment (PPE) used in operating rooms, rate of postoperative infection among healthcare staff and complications, within 30-postoperative days. 68 patients, who underwent surgery, resulted COVID-19-positive in the perioperative period. Symptomatic patients were 63 (92.5%). Fever was the main symptom in 36 (52.9%) patients, followed by dyspnoea (26.5%) and cough (13.2%). We recorded 22 (32%) intensive care unit admissions, 23 (33.8%) postoperative pulmonary complications and 15 (22%) acute respiratory distress syndromes. As regards the ten postoperative deaths (14.7%), 6 cases were related to surgical complications. One surgeon, one scrub nurse and two circulating nurses were infected after surgery due to the lack of specific PPE. We reported less surgery-related pulmonary complications and mortality in Sars-CoV-2-infected patients, than in literature. Emergent and oncological surgery should not be postponed, but it is mandatory to use full PPE, and to adopt preoperative screenings and strategies that mitigate the detrimental effect of pulmonary complications, mostly responsible for mortality.

Rare Intraoperative and Postoperative Complications After Transabdominal Laparoscopic Hernia Repair: Results from the Multicenter Wall Hernia Group Registry.

Background: Inguinal hernioplasty is the most frequently performed operation in the Western world today. Although the laparoscopic approach for inguinal hernia repair has shown excellent results in terms of complications and recurrences, the anterior approach is still the most used. Postoperative pain and recurrences are the most widely studied complications in both approaches, but there is little information about the often more troublesome rare complications of laparoscopic surgery and their treatment. Methods: In the period from January 1, 2014 to December 31, 2019, 1874 hernioplasty operations were performed with the transabdominal approach and recorded prospectively in the Wall Hernia Group database. The mean follow-up was 47 months (range 3-64 months). All less frequent complications were analyzed and a literature review was carried out to assess the presence of similar cases and their treatment in other series. Results: Eight cases of rare complications were identified and subdivided according to the Clavien-Dindo classification. They included a bowel perforation, 4 cases of bleeding, 2 bowel obstructions, and an injury to the motor branch of the obturator nerve. The postoperative course in these patients was significantly longer than in patients with a regular postoperative course. In 2 cases the complication occurred during the first admission, while the remaining 6 patients had to be readmitted within 30 days after discharge. Conclusions: Although serious postoperative complications in laparoscopic inguinal hernioplasty are rare, all surgeons, also those who have completed the learning curve, should be aware of their possible occurrence.

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in pseudomyxoma peritonei of appendiceal origin: result of a single centre study.

Pseudomyxoma peritonei (PMP) is a rare condition characterized by the intraperitoneal accumulation of mucus derived mostly by appendiceal mucinous neoplasm. Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) can offer a favourable overall survival. In this study, we report a single-institute outcomes following CRS and HIPEC in patients with this condition. This is a review of prospectively collected data from 32 patients (11 men and 21 women) affected by PMP of appendiceal origin who underwent CRS and HIPEC from 2008 to 2016 in our Surgical Unit of General and Esophagogastric Surgery. The median age of the patients was 53 years (range 25-77 years). After CRS, all patients underwent HIPEC (mytomicin C 3.3 mg/m2/L and cisplatin 25 mg/m2/L at 41 °C for 60 min) with closed abdomen technique. The median (range) follow-up time for surviving patients was 43 (18-119) months. The median peritoneal cancer index (PCI) was 17. Complete cytoreductive surgery (CC0) was achieved in in 22 patients (69%). The majority of patients (88%) had grade I-II complications, 3 (9%) had grade III complications, and 1 (3%) patient had a grade IV complication. There were no perioperative mortalities. The median hospital stay was 9.5 (range 9-24) days. One year and 5-year overall survival (OS) were 90% and 58%, respectively. Regardless of histotype, disease-free survival was 95% at 1 year and 46% at 5 years. CRS in combination with HIPEC is a feasible treatment strategy and can achieve a satisfactory outcome in patients with PMP of appendiceal origin.

Elevated platelet count is a negative predictive and prognostic marker in locally advanced rectal cancer undergoing neoadjuvant chemoradiation: a retrospective multi-institutional study on 965 patients.

BACKGROUND: In patients with locally advanced rectal cancer treated by neoadjuvant chemoradiation, pathological complete response in the surgical specimen is associated with favourable long-term oncologic outcome. Based on this observation, nonoperative management is being explored in the subset of patients with clinical complete response. Whereas, patients with poor response have a high risk of local and distant recurrence, and appear to receive no benefit from standard neoadjuvant chemoradiation. Therefore, in order to develop alternative treatment strategies for non responding patients, predictive and prognostic factors are highly needed. Accumulating clinical observations indicate that elevated platelet count is associated with poor outcome in different type of tumors. In this study we investigated the predictive and prognostic impact of elevated platelet count on pathological response and long-term oncologic outcome in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation. METHODS: A total of 965 patients were selected from prospectively maintained databases of seven Centers within the SICO Colorectal Cancer Network. Patients were divided into two groups based on a pre-neoadjuvant chemoradiation platelet count cut-off value of 300 × 109/L identified by receiver operating characteristic curve considering complete pathological response as the outcome. RESULTS: Complete pathological response rate was lower in patients with elevated platelet count (12.8% vs. 22.1%, p = 0.001). Mean follow-up was 50.1 months. Comparing patients with elevated platelet count with patients with not elevated platelet count, 5-year overall survival was 69.5% vs.76.5% (p = 0.016), and 5-year disease free survival was 63.0% vs. 68.9% (p = 0.019). Local recurrence rate was higher in patients with elevated platelet count (11.1% vs. 5.3%, p = 0.001), as higher was the occurrence of distant metastasis (23.9% vs. 16.4%, p = 0.007). At multivariate analysis of potential prognostic factors EPC was independently associated with worse overall survival (HR 1.40, 95% CI 1.06-1.86), and disease free survival (HR 1.37, 95% CI 1.07-1.76). CONCLUSIONS: In locally advanced rectal cancer elevated platelet count before neoadjuvant chemoradiation is a negative predictive and prognostic factor which might help to identify subsets of patients with more aggressive tumors to be proposed for alternative therapeutic strategies.

Complications after gastrectomy for cancer: Italian perspective.

Surgery for gastric cancer is associated with significant major morbidity and an estimated mortality rate of about 5%. A reliable comparison of post-operative outcomes is hampered by the lack of a clear, universally recognized, definition of the most frequent complications. This paper reports the final results of a project launched by the Italian Research Group for Gastric Cancer in September 2015, whose goal was to propose a comprehensive list of surgical-related, gastric cancer-specific complications, with their definitions. The project was carried out through a multicentric, mainly web-based, consensus of experts. The proposed list, following assessment and validation by a group of experts of the European Chapter of the International Gastric Cancer Association, will form the basis for implementing a "Complications Recording Sheet" that can be disseminated worldwide for proper and reliable post-operative assessment.

Incidence and Prognostic Value of Metastases to "Posterior" and Para-aortic Lymph Nodes in Resectable Gastric Cancer.

BACKGROUND: The purpose of this retrospective study was to evaluate the incidence and prognostic value of metastases to "posterior" (8p, 12b/p, 13) and para-aortic lymph nodes in a large cohort of Western patients submitted to D2 plus lymphadenectomy. METHODS: Removal of "posterior" nodes was performed in 743 patients, and para-aortic lymphadenectomy in a subgroup of 390 patients. After lymph node mapping and retrieval on the fresh specimen, a median number of 41 total lymph nodes were analyzed. The median follow-up period was 37 months for the entire series and 68 months for survivors. RESULTS: Of 743 included patients, 23 (3.1%) had metastases in station 8p, 12 (1.6%) in station 12b/p, and 19 (2.6%) in station 13. On the whole, 47 of 743 patients (6.3%) had positive "posterior" nodes. Para-aortic metastases were present in 42 of 390 patients (10.8%). Metastases to "posterior" stations were significantly related to depth of invasion, number of positive nodes, and surgical radicality. Distal tumors showed higher trend to metastasize to "posterior" nodes than upper third, whereas for para-aortic metastases it was the reverse. 5-year survival in patients with positivity to "posterior" nodes was 17%, with no significant difference according to 8p, 12b/p, and 13 stations; long-term outcome was overlapping to pN3b stage. 5-year survival in para-aortic positive cases was 11%, and a trend to better outcome was observed in proximal tumors. CONCLUSIONS: Although metastases to "posterior" and para-aortic nodes are expression of an advanced nodal stage, not negligible survival rates are observed in subgroups of patients.

Siewert III adenocarcinoma: treatment update.

Siewert III cancer, although representing around 40% of EGJ cancers and being the EGJ cancer with worst prognosis, does not have a homogenous treatment, has few dedicated studies, and is often not considered in study protocols. Although staged as an esophageal cancer by the TNM 7th ed., it is considered a gastric cancer by new TNM 8th ed. Our aim was to consolidate the current literature on the indications and treatment options for Siewert III adenocarcinoma. A review of the literature was performed to better delineate treatment indications (according to stage, surgical margins, type of lymphatic spread and lymphadenectomy) and treatment strategy. The treatment approach is strictly dependent on cancer site and nodal diffusion. T1m cancers have insignificant risk of nodal metastases and can be safely treated with endoscopic resections. The risk of nodal metastases increases markedly starting from T1sm cancers and requires surgery with lymphadenectomy. The site of this type of cancer and the nodal diffusion require a total gastrectomy and distal esophagectomy, with 5 cm of clear proximal and distal margins and a D2 abdominal and inferior mediastinal lymphadenectomy. Multimodal treatments are indicated in all locally advanced and node positive cancers. Siewert III cancers are gastric cancers with some peculiarities and require dedicated studies and deserve more consideration in the current literature, especially because their treatment is particularly challenging.

The Italian Research Group for Gastric Cancer (GIRCG) guidelines for gastric cancer staging and treatment: 2015.

This article reports the guidelines for gastric cancer staging and treatment developed by the GIRCG, and contains comprehensive indications for clinical management, including radiological, endoscopic, surgical, pathological, and oncological paths.

ypN0: Does It Matter How You Get There? Nodal Downstaging in Esophageal Cancer.

BACKGROUND: ypN0 following induction treatment for advanced esophageal cancer improves survival. Importance of how ypN0 is achieved is unknown. This study evaluates survival in "natural" N0 (cN0/ypN0) and "downstaged" N0 (cN+/ypN0) patients. METHODS: Among patients treated with induction treatment and surgery, 83 CT scans were retrieved in digital format and re-evaluated by a radiologist, blinded to pathological nodal status: 28 natural N0, 37 downstaged N0, and 18 ypN+. Impact of N0 classification on survival and associations with survival were identified. RESULTS: Survival varied with ypN: 3-year survival was 84 % for natural N0 patients, 59 % for downstaged N0, and 20 % for ypN+ (p < .001). Compared with natural N0 patients, risk of cancer mortality was 3.8 for downstaged N0 and 7.6 for ypN+ (p = .01). Survival was also stratified by ypT: compared with ypT0 natural N0, who had the best survival, intermediate survival was seen in ypT+ natural N0 [hazard ratio (HR), 1.3] and ypT0 downstaged N0 (HR, 1.8), and poor survival in ypT+ downstaged N0 (HR, 9.5) and ypN+ (HR, 12.0) (p = .026). CONCLUSIONS: Natural N0 and downstaged N0 patients are different clinical entities: downstaging cN+ with induction treatment producing downstaged N0 improves survival only if there is concomitant primary cancer downstaging to ypT0. Intermediate survival is seen in downstaged N0 patients with complete tumor response. Natural N0 patients experience intermediate survival with incomplete response (ypT+). Complete response in natural N0 patients produces the best survival. Means of obtaining ypN0 status matters and requires a complete response for downstaged N0 patients to benefit from induction treatment.

Gastric cancer: Current status of lymph node dissection.

D2 procedure has been accepted in Far East as the standard treatment for both early (EGC) and advanced gastric cancer (AGC) for many decades. Recently EGC has been successfully treated with endoscopy by endoscopic mucosal resection or endoscopic submucosal dissection, when restricted or extended Gotoda's criteria can be applied and D1+ surgery is offered only to patients not fitted for less invasive treatment. Furthermore, two randomised controlled trials (RCTs) have been demonstrating the non inferiority of minimally invasive technique as compared to standard open surgery for the treatment of early cases and recently the feasibility of adequate D1+ dissection has been demonstrated also for the robot assisted technique. In case of AGC the debate on the extent of nodal dissection has been open for many decades. While D2 gastrectomy was performed as the standard procedure in eastern countries, mostly based on observational and retrospective studies, in the west the Medical Research Council (MRC), Dutch and Italian RCTs have been conducted to show a survival benefit of D2 over D1 with evidence based medicine. Unfortunately both the MRC and the Dutch trials failed to show a survival benefit after the D2 procedure, mostly due to the significant increase of postoperative morbidity and mortality, which was referred to splenopancreatectomy. Only 15 years after the conclusion of its accrual, the Dutch trial could report a significant decrease of recurrence after D2 procedure. Recently the long term survival analysis of the Italian RCT could demonstrate a benefit for patients with positive nodes treated with D2 gastrectomy without splenopancreatectomy. As nowadays also in western countries D2 procedure can be done safely with pancreas preserving technique and without preventive splenectomy, it has been suggested in several national guidelines as the recommended procedure for patients with AGC.

Short-term and long-term risk factors in gastric cancer.

While in chronic diseases, such as diabetes, mortality rates slowly increases with age, in oncological series mortality usually changes dramatically during the follow-up, often in an unpredictable pattern. For instance, in gastric cancer mortality peaks in the first two years of follow-up and declines thereafter. Also several risk factors, such as TNM stage, largely affect mortality in the first years after surgery, while afterward their effect tends to fade. Temporal trends in mortality were compared between a gastric cancer series and a cohort of type 2 diabetic patients. For this purpose, 937 patients, undergoing curative gastrectomy with D1/D2/D3 lymphadenectomy for gastric cancer in three GIRCG (Gruppo Italiano Ricerca Cancro Gastrico = Italian Research Group for Gastric Cancer) centers, were compared with 7148 type 2 diabetic patients from the Verona Diabetes Study. In the early/advanced gastric cancer series, mortality from recurrence peaked to 200 deaths per 1000 person-years 1 year after gastrectomy and then declined, becoming lower than 40 deaths per 1000 person-years after 5 years and lower than 20 deaths after 8 years. Mortality peak occurred earlier in more advanced T and N tiers. At variance, in the Verona diabetic cohort overall mortality slowly increased during a 10-year follow-up, with ageing of the type 2 diabetic patients. Seasonal oscillations were also recorded, mortality being higher during winter than during summer. Also the most important prognostic factors presented a different temporal pattern in the two diseases: while the prognostic significance of T and N stage markedly decrease over time, differences in survival among patients treated with diet, oral hypoglycemic drugs or insulin were consistent throughout the follow-up. Time variations in prognostic significance of main risk factors, their impact on survival analysis and possible solutions were evaluated in another GIRCG series of 568 patients with advanced gastric cancer, undergoing curative gastrectomy with D2/D3 lymphadenectomy. Survival curves in the two different histotypes (intestinal and mixed/diffuse) were superimposed in the first three years of follow-up and diverged thereafter. Likewise, survival curves as a function of site (fundus vs body/antrum) started to diverge after the first year. On the contrary, survival curves differed among age classes from the very beginning, due to different post-operative mortality, which increased from 0.5% in patients aged 65-74 years to 9.9% in patients aged 75-91 years; this discrepancy later disappeared. Accordingly, the proportional hazards assumption of the Cox model was violated, as regards age, site and histology. To cope with this problem, multivariable survival analysis was performed by separately considering either the first two years of follow-up or subsequent years. Histology and site were significant predictors only after two years, while T and N, although significant both in the short-term and in the long-term, became less important in the second part of follow-up. Increasing age was associated with higher mortality in the first two years, but not thereafter. Splitting survival time when performing survival analysis allows to distinguish between short-term and long-term risk factors. Alternative statistical solutions could be to exclude post-operative mortality, to introduce in the model time-dependent covariates or to stratify on variables violating proportionality assumption.

Gastric stump cancer after distal gastrectomy for benign disease: clinicopathological features and surgical outcomes.

PURPOSE: The purpose of the present study was to analyze clinicopathologic features and long-term prognosis of gastric stump cancer (GSC) arising in the remnant stomach 5 years or later after partial gastrectomy for benign disease. METHODS: We reviewed the results of 176 patients resected with curative intent for GSC at 8 Italian centers belonging to the Italian Research Group for Gastric Cancer (GIRCG). The median (range) follow-up time for surviving patients was 71.2 (6-207) months. RESULTS: One hundred forty-six patients were men, the mean age at the time of diagnosis was 69.2 years, and the great majority (167 cases) underwent Billroth II reconstruction. R0 resection was achieved in 158 (90 %) patients, and in 94 (53 %) lymph node dissection was ≥D2. Postoperative mortality and complication rates were 6.2 and 43.2 %, respectively. T1 tumor was diagnosed in 45 (25 %) cases. Lymph node metastases were evident in 86 patients (49 %). Thirteen patients had involvement of the jejunal mesentery nodes (pJN+); five cases were T2-T3 and eight cases were T4. Overall 5-year survival rate was 53.1 %. Five-year survival rates were 68.1, 37.8, and 33.1 % for pT1, pT2-3, and pT4 tumors, respectively (P = 0.001). Five-year survival rate was 56.5 % for node-negative tumors (pN0), 32.3 % for tumors with nodal metastases without involvement of jejunal mesentery nodes (pN+), and 17.1 % for tumors with involvement of jejunal mesentery nodes (pJN+) (P = 0.002). CONCLUSIONS: Our study suggests that an aggressive surgical approach can achieve a satisfactory outcome in GSC.