High-energy devices in different surgical settings: lessons learnt from a full health technology assessment report developed by SICE (Società Italiana di Chirurgia Endoscopica).

BACKGROUND: The present paper aims at evaluating the potential benefits of high-energy devices (HEDs) in the Italian surgical practice, defining the comparative efficacy and safety profiles, as well as the potential economic and organizational advantages for hospitals and patients, with respect to standard monopolar or bipolar devices. METHODS: A Health Technology Assessment was conducted in 2021 assuming the hospital perspective, comparing HEDs and standard monopolar/bipolar devices, within eleven surgical settings: appendectomy, hepatic resections, colorectal resections, cholecystectomy, splenectomy, hemorrhoidectomy, thyroidectomy, esophago-gastrectomy, breast surgery, adrenalectomy, and pancreatectomy. The nine EUnetHTA Core Model dimensions were deployed considering a multi-methods approach. Both qualitative and quantitative methods were used: (1) a systematic literature review for the definition of the comparative efficacy and safety data; (2) administration of qualitative questionnaires, completed by 23 healthcare professionals (according to 7-item Likert scale, ranging from - 3 to + 3); and (3) health-economics tools, useful for the economic evaluation of the clinical pathway and budget impact analysis, and for the definition of the organizational and accessibility advantages, in terms of time or procedures' savings. RESULTS: The literature declared a decrease in operating time and length of stay in using HEDs in most surgical settings. While HEDs would lead to a marginal investment for the conduction of 178,619 surgeries on annual basis, their routinely implementation would generate significant organizational savings. A decrease equal to - 5.25/-9.02% of operating room time and to - 5.03/-30.73% of length of stay emerged. An advantage in accessibility to surgery could be hypothesized in a 9% of increase, due to the gaining in operatory slots. Professionals' perceptions crystallized and confirmed literature evidence, declaring a better safety and effectiveness profile. An improvement in both patients and caregivers' quality-of-life emerged. CONCLUSIONS: The results have demonstrated the strategic relevance related to HEDs introduction, their economic sustainability, and feasibility, as well as the potentialities in process improvement.

Short- and long-term outcomes in ypT2 rectal cancer patients after neoadjuvant therapy and local excision: a multicentre observational study.

BACKGROUND: Although local excision (LE) after neoadjuvant treatment (NT) has achieved encouraging oncological outcomes in selected patients, radical surgery still remains the rule when unfavorable pathology occurs. However, there is a risk of undertreating patients not eligible for radical surgery. The aim of this study was to evaluate the outcomes of patients with pathological incomplete response (ypT2) in a multicentre cohort of patients undergoing LE after NT and to compare them with ypT0-is-1 rectal cancers. METHODS: From 2010 to 2019, all patients who underwent LE after NT for rectal cancer were identified from five institutional retrospective databases. After excluding 12 patients with ypT3 tumors, patients with ypT2 tumors were compared to patients with ypT0-is-1 tumors). The endpoints of the study were early postoperative and long-term oncological outcomes. RESULTS: A total of 177 patients (132 males, 45 females, median age 70 [IQR 16] years) underwent LE following NT. There were 46 ypT2 patients (39 males, 7 females, median age 72 [IQR 18.25] years) and 119 ypT0-is-1 patients (83 males, 36 females, median age 69 [IQR 15] years). Patients with pathological incomplete response (ypT2) were frailer than the ypT0-is-1 patients (mean Charlson Comorbidity Index 6.15 ± 2.43 vs. 5.29 ± 1.99; p = 0.02) and there was a significant difference in the type of NT used for the two groups (long- course radiotherapy: 100 (84%) vs. 23 (63%), p = 0.006; short-course radiotherapy: 19 (16%) vs. 17 (37%), p = 0.006). The postoperative rectal bleeding rate (13% vs. 1.7%; p = 0.008), readmission rate (10.9% vs. 0.8%; p = 0.008) and R1 resection rate (8.7% vs. 0; p = 0.008) was significantly higher in the ypT2 group. Recurrence rates were comparable between groups (5% vs. 13%; p = 0.15). Five-year overall survival was 91.3% and 94.9% in the ypT2 and ypT0-is-1 groups, respectively (p = 0.39), while 5-year cancer specific survival was 93.4% in the ypT2 group and 94.9% in the ypT0-is-1 group (p = 0.70). No difference was found in terms of 5-year local recurrence free-survival (p = 0.18) and 5-year distant recurrence free-survival (p = 0.37). CONCLUSIONS: Patients with ypT2 tumors after NT and LE have a higher risk of late-onset rectal bleeding and positive resection margins than patients with complete or near complete response. However, long-term recurrence rates and survival seem comparable.

Contemporary snapshot of tumor regression grade (TRG) distribution in locally advanced rectal cancer: a cross sectional multicentric experience.

Pre-operative chemoradiotherapy (CRT) followed by surgical resection is still the standard treatment for locally advanced low rectal cancer. Nowadays new strategies are emerging to treat patients with a complete response to pre-operative treatment, rendering the optimal management still controversial and under debate. The primary aim of this study was to obtain a snapshot of tumor regression grade (TRG) distribution after standard CRT. Second, we aimed to identify a correlation between clinical tumor stage (cT) and TRG, and to define the accuracy of magnetic resonance imaging (MRI) in the restaging setting. Between January 2017 and June 2019, a cross sectional multicentric study was performed in 22 referral centers of colon-rectal surgery including all patients with cT3-4Nx/cTxN1-2 rectal cancer who underwent pre-operative CRT. Shapiro-Wilk test was used for continuous data. Categorical variables were compared with Chi-squared test or Fisher's exact test, where appropriate. Accuracy of restaging MRI in the identification of pathologic complete response (pCR) was determined evaluating the correspondence with the histopathological examination of surgical specimens.In the present study, 689 patients were enrolled. Complete tumor regression rate was 16.9%. The "watch and wait" strategy was applied in 4.3% of TRG4 patients. A clinical correlation between more advanced tumors and moderate to absent tumor regression was found (p = 0.03). Post-neoadjuvant MRI had low sensibility (55%) and high specificity (83%) with accuracy of 82.8% in identifying TRG4 and pCR.Our data provided a contemporary description of the effects of pre-operative CRT on a large pool of locally advanced low rectal cancer patients treated in different colon-rectal surgical centers.

Robot-assisted laparoscopic subtotal gastrectomy for early-stage gastric cancer: Case series of initial experience.

BACKGROUND: In the last decade's robotic gastrectomy (RG) has increasingly widespread as a valid minimally invasive option for treatment of gastric cancer. In literature, evidence of its routine use is not yet well established. The aims of this study are to report our initial experience and to present possible advantages of our hybrid operative technique for subtotal gastrectomy. MATERIALS AND METHODS: Retrospectively, we analyzed data from 41 patients (22 male and 19 female) who underwent robot-assisted laparoscopic subtotal gastrectomy (RALG) with D2 lymphadenectomy using the da Vinci XI robotic system. Inclusion criteria were gastric cancer in the middle or lower portion of the stomach amenable of radical subtotal gastrectomy without preoperative suspicion of positive lymph-nodes or other organs involving and distant metastasis. All the procedures were performed by attending surgeons. RESULTS: The mean operative time was 270 min with one case of conversion to open surgery. The mean age was 71.4 (IQR 68.2-76.8) with 43.9% of patients classified as ASA (American Society of Anesthesiologists) score ≥3. The median of lymph-nodes retrieved was 25 (IQR 19-35). No intra-operative complications occurred. Time to resume a soft diet was 5 days. Patients were hospitalized a median of 7 days. According to pathological AJCC-TNM, 21 patients were classified as advanced gastric cancer. Post-operative morbidity was recorded in 9 patients (21.9%) with major complications requiring surgical operation in 4 patients (9.8%). Elevated ASA score, fewer lymph-nodes retrieved and ICU recovery requirements were significant increased in patients with major complications. CONCLUSION: The preliminary results demonstrated that robot-assisted laparoscopic subtotal gastrectomy is safe and feasible. In particular, we found that the da Vinci platform improves surgeon abilities to perform an adequate lymphadenectomy and digestive reconstruction. Further studies are necessary to better clarify the role of this high-cost technology in minimally invasive treatment of gastric cancer.

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.

Current status on the adoption of high energy devices in Italy: An Italian Society for Endoscopic Surgery and New Technologies (SICE) national survey.

BACKGROUND: In the past three decades, different High Energy Devices (HED) have been introduced in surgical practice to improve the efficiency of surgical procedures. HED allow vessel sealing, coagulation and transection as well as an efficient tissue dissection. This survey was designed to verify the current status on the adoption of HED in Italy. METHODS: A survey was conducted across Italian general surgery units. The questionnaire was composed of three sections (general information, elective surgery, emergency surgery) including 44 questions. Only one member per each surgery unit was allowed to complete the questionnaire. For elective procedures, the survey included questions on thyroid surgery, lower and upper GI surgery, proctologic surgery, adrenal gland surgery, pancreatic and hepatobiliary surgery, cholecystectomy, abdominal wall surgery and breast surgery. Appendectomy, cholecystectomy for acute cholecystitis and bowel obstruction due to adhesions were considered for emergency surgery. The list of alternatives for every single question included a percentage category as follows: " < 25%, 25-50%, 51-75% or > 75%", both for open and minimally-invasive surgery. RESULTS: A total of 113 surgical units completed the questionnaire. The reported use of HED was high both in open and minimally-invasive upper and lower GI surgery. Similarly, HED were widely used in minimally-invasive pancreatic and adrenal surgery. The use of HED was wider in minimally-invasive hepatic and biliary tree surgery compared to open surgery, whereas the majority of the respondents reported the use of any type of HED in less than 25% of elective cholecystectomies. HED were only rarely employed also in the majority of emergency open and laparoscopic procedures, including cholecystectomy, appendectomy, and adhesiolysis. Similarly, very few respondents declared to use HED in abdominal wall surgery and proctology. The distribution of the most used type of HED varied among the different surgical interventions. US HED were mostly used in thyroid, upper GI, and adrenal surgery. A relevant use of H-US/RF devices was reported in lower GI, pancreatic, hepatobiliary and breast surgery. RF HED were the preferred choice in proctology. CONCLUSION: HED are extensively used in minimally-invasive elective surgery involving the upper and lower GI tract, liver, pancreas and adrenal gland. Nowadays, reasons for choosing a specific HED in clinical practice rely on several aspects, including surgeon's preference, economic features, and specific drawbacks of the energy employed.

Acute cholecystitis during COVID-19 pandemic: a multisocietary position statement.

Following the spread of the infection from the new SARS-CoV2 coronavirus in March 2020, several surgical societies have released their recommendations to manage the implications of the COVID-19 pandemic for the daily clinical practice. The recommendations on emergency surgery have fueled a debate among surgeons on an international level.We maintain that laparoscopic cholecystectomy remains the treatment of choice for acute cholecystitis, even in the COVID-19 era. Moreover, since laparoscopic cholecystectomy is not more likely to spread the COVID-19 infection than open cholecystectomy, it must be organized in such a way as to be carried out safely even in the present situation, to guarantee the patient with the best outcomes that minimally invasive surgery has shown to have.

Laparoscopic pancreaticoduodenectomy: experience of 22 cases.

BACKGROUND: Laparoscopic pancreatic surgery has gradually expanded its applications to include pancreaticoduodenectomy. However, the benefits of the laparoscopic approach are still debated. This article aims to present data regarding the efficacy of laparoscopic pancreaticoduodenectomy in a single center. METHODS: From March 2003 to June 2010, a total of 22 patients underwent pancreaticoduodenectomy with a totally laparoscopic approach, using a five-trocar technique. Reconstruction of the digestive tract was adapted to the aspect of the pancreatic stump, with 6 patients having Wirsung duct occlusion and 16 patients pancreaticodigestive anastomosis. Patient selection, short-term outcomes, oncologic results, and technical issues were retrospectively reviewed. RESULTS: Mean operative time was 392 (range, 327-570) min. Conversion was required in 2 patients (9.1 %) as a result of bleeding and difficult dissection. Major intraoperative complications included an injury to the right hepatic artery (4.5 %). Postoperative mortality was 4.5 %. Surgery-related morbidity occurred in 14 patients (63.6 %) and included bleeding (n = 5), pancreatic fistula (n = 6), biliary fistula (n = 2), and dumping syndrome (n = 1). Pancreatic fistulas occurred in 4 patients with duct occlusion and in 2 patients with pancreaticojejunostomy, and they all healed with conservative treatment. Mean hospital stay was 23 (range, 12-35) days. Pathologic diagnoses were pancreatic ductal adenocarcinoma (n = 11), ampullary adenocarcinoma (n = 8), and duodenal adenocarcinoma (n = 3). The resection margins were all free from disease; the mean number of collected lymph nodes was 15 (range, 14-20). CONCLUSIONS: The complexity of pancreaticoduodenectomy entails some issues, including patient selection and management of the pancreatic stump, that are not related to the approach used. Laparoscopic pancreaticoduodenectomy is feasible, safe, and oncologically adequate, but only if performed in selected cases by highly skilled laparoscopic surgeons. Laparoscopy does not provide any significant advantage over traditional surgery, but it may improve postoperative outcomes in the so-called excellence centers, once the learning curve has been overcome. Multicenter randomized trials are needed.

Voluminous bleeding stomach GIST: reflections on etiopathogenesis, diagnosis and therapy.

Gastrointestinal stromal tumours (GIST) constitute a heterogeneous group of neoplasms which, although rare (around 1% of the total number of malignant tumours), are the most common mesenchymal tumours of the gastrointestinal tract. In the past they were not very well known, whereas today, thanks to the remarkable progress made in the immunohistochemical and molecular fields, considerable knowledge has been acquired, offering new opportunities for classification and, above all, for a more adequate multidisciplinary treatment of this pathology. In this study, the authors report a case of a bleeding GIST of the stomach which they recently observed and discuss it in the light of recent reflections on the aetiopathogenesis, diagnosis and therapy of these tumours in the literature.

Rare cases of bowel obstruction: internal hernias.

Internal hernias are a rare form of dislocation of the abdominal viscera, usually in the small intestine, in the peritoneal sacs or cavities, resulting from the defective coalescence of the peritoneal flaps due to abnormal rotation of the medium intestine in the second stage of embryogenesis. In this paper the authors describe three cases observed during the last twelve months: two cases were ascribable to left paraduodenal hernia and one to a transepiploic hernia. Special attention needs to be paid to knowledge of the rotation process of the primitive medium intestine and to understanding whether an internal hernia underlies the clinical picture, when occlusive patients have not previously undergone surgery and show no signs of external hernias. In the surgical treatment of paraduodenal hernias, special attention must be paid to incarcerated loops, in order to prevent severe vascular complications caused by potential lesions to the mesenteric vessels.

Laparoscopic treatment of unicentric Castleman's disease with abdominal localization.

We report a case of unicentric Castleman's disease (angiofollicular lymph node hyperplasia) with abdominal localization, that was treated laparoscopically. The patient, a 23-year-old male, was referred to our unit for subtle symptoms of recurrent palpitations and vague abdominal pain. His physician had prescribed an abdominal echtomograph, which showed a mass located at the lower and anterior lower splenic pole. In order to reach a definite diagnosis and prescribe adequate treatment, a diagnostic laparoscopy was performed. Exploration of the abdominal cavity helped detect a well-vascularized solid round mass at the level of the left hypochondrium, with a vascular pedicle; the lesion was detached, and the pedicle sectioned using an Endo-GIA 40. The postoperative course was regular and the patient was discharged on postoperative day 2. The laparoscopic approach enabled the resection of the lesion (with consequent histological diagnosis) and exploration of the peritoneal cavity with the advantages of minimal invasiveness, magnified images, and more rapid recovery). The pathology was totally resolved, with satisfactory results in terms of recovery, postoperative pain, and cosmesis.