Rectal Surgery Evaluation Trial: protocol for a parallel cohort trial of outcomes using surgical techniques for total mesorectal excision with low anterior resection in high-risk rectal cancer patients.

AIM: Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgery technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery and transanal surgery. Comparative data for these techniques are required to provide clinical data on the surgical management of rectal cancers. METHODS: The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicentre trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery or transanal surgery in high-surgical-risk patients with mid-to-low non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in at least one of the techniques. Oncological, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥ 1 mm, TME Grade III and minimal postoperative morbidity (absence of Clavien-Dindo Grade III-IV complications within 30 days after surgery). Secondary end-points will include the co-primary end-points over the long term (2 years), quality of surgery, quality of life, length of hospital stay, operative time and rate of unplanned conversions. DISCUSSION: This will be the first trial to study all four surgical techniques currently used for TME with LAR in a specific group of high-risk patients. The knowledge obtained will contribute towards helping physicians determine the advantages of each technique and which may be the most appropriate for their patients.

European consensus on the standardization of robotic total mesorectal excision for rectal cancer.

AIM: Surgery for rectal cancer is challenging for both technical and anatomical reasons. The European Academy of Robotic Colorectal Surgery (EARCS) provides a competency-based training programme through a standardized approach. However, there is no consensus on technical standards for robotic surgery when used during surgery for rectal cancer. The aim of this consensus study was to establish operative standards for anterior resection incorporating total mesorectal excision (TME) using robotic techniques, based on recommendations of expert European colorectal surgeons. METHOD: A Delphi questionnaire with a 72-item statement was sent through an electronic survey tool to 24 EARCS faculty members from 10 different countries who were selected based on expertise in robotic colorectal surgery. The task was divided into theatre setup, colonic mobilization and rectal dissection, and each task area was further divided into several subtasks. The levels of agreement (A* > 95% agreement, A > 90%, B > 80% and C > 70%) were considered adequate while agreement of < 70% was considered inadequate. Once consensus was reached, a draft document was compiled and sent out for final approval. RESULTS: The average length of experience of robotic colorectal surgery for participants in this study was 6 years. Initial agreement was 87%; in nine items, it was < 70%. After suggested modifications, the average level of agreement for all items reached 94% in the second round (range 0.75-1). CONCLUSION: This is the first European consensus on the standardization of robotic TME. It provides a baseline for technical standards and structured training in robotic rectal surgery.

Genital marginal failures after intensity-modulated radiation therapy (IMRT) in squamous cell anal cancer: no higher risk with IMRT when compared to 3DCRT.

Intensity-modulated radiotherapy (IMRT) is considered the preferred option in squamous cell canal cancer (SCAC), delivering high doses to tumor volumes while minimizing dose to surrounding normal tissues. IMRT has steep dose gradients, but the technique is more demanding as deep understanding of target structures is required. To evaluate genital marginal failure in a cohort of patients with non-metastatic SCAC treated either with IMRT or 3DCRT and concurrent chemotherapy, 117 patients with SCAC were evaluated: 64 and 53 patients were treated with IMRT and 3DCRT techniques, respectively. All patients underwent clinical and radiological examination during their follow-up. Tumor response was evaluated with response evaluation criteria in solid tumors v1.1 guideline on regular basis. All patients' data were analyzed, and patients with marginal failure were identified. Concomitant chemotherapy was administered in 97 and 77.4% of patients in the IMRT and 3DCRT groups, respectively. In the IMRT group, the median follow-up was 25 months (range 6-78). Progressive disease was registered in 15.6% of patients; infield recurrence, distant recurrence and both infield recurrence and distant recurrence were identified in 5, 4 and 1 patient, respectively. Two out of 64 patients (3.1%) had marginal failures, localized at vagina/recto-vaginal septum and left perineal region. In the 3DCRT group, the median follow-up was 71.3 months (range 6-194 months). Two out of 53 patients (3.8%) had marginal failures, localized at recto-vaginal septum and perigenital structures. The rate of marginal failures was comparable in IMRT and 3DCRT groups (χ2 test p = 0.85). In this series, the use of IMRT for the treatment of SCAC did not increase the rate of marginal failures offering improved dose conformity to the target. Dose constraints should be applied with caution-particularly in females with involvement of the vagina or the vaginal septum.

Suprapubic approach for robotic complete mesocolic excision in right colectomy: Oncologic safety and short-term outcomes of an original technique.

INTRODUCTION: Right-sided colon cancer has a worse prognosis than left-sided colon cancer. Complete mesocolic excision (CME) with central vessels ligation (CVL) reduces local recurrence, but is technically demanding, particularly with a laparoscopic approach. Aim of this study is to describe a new robotic approach to right colectomy with CME and CVL and to report oncologic safety and short term outcomes. METHODS: Twenty consecutive patients were included. All patients had a right colon adenocarcinoma and underwent right colectomy with a suprapubic approach. Surgery was realized with the Da Vinci Xi® system and all trocars were placed along a horizontal line 3-6 cm above the pubis. CME with CVL was realized in all the patients. Data analysed were: duration of surgery, conversions to open surgery, intraoperative and postoperative complication by Clavien Dindo classification, margins of resections, length of specimen and number of lymph nodes retrieved. RESULTS: Patients median age was 69 years, median body mass index was 27 kg/m2. Median operative time was 249 min, blood loss was negligible, no conversions to open or laparoscopic surgery occurred. Median hospital stay was six days; two postoperative grade IIIa Clavien-Dindo complications occurred, no 30-days postoperative death was registered. Resection margins were negative in all patients; median tumour diameter was 3.6 cm, median specimen length was 40 cm, median number of harvested lymph nodes was 40. CONCLUSIONS: Robotic right colectomy with CME using a suprapubic approach is a feasible and safe technique that allows for an extended lymphadenectomy and provides high quality surgical specimens.

Evaluation of the robotic approach concerning pitfalls in rectal surgery.

INTRODUCTION: The feasibility and advantages of robotic rectal surgery (RRS) in comparison to conventional open or laparoscopic rectal resections have been postulated in several reports. But well-known challenges and pitfalls of minimal invasive rectal surgery have not been evaluated by a prospective, multicenter setting so far. Aim of this study was to analyze the perioperative outcome of patients following RRS especially in regard to the pitfalls such as obesity, male patients and low tumors by a European multicenter setting. METHODS: This prospective study included 348 patients undergoing robotic surgery due to rectal cancer in six major European centers. Clinicopathological parameters, morbidity, perioperative recovery and short-term outcome were analyzed. RESULTS: A total of 283 restorative surgeries and 65 abdominoperineal resections were carried out. The conversion rate was 4.3%, mean blood loss was 191 ml, and mean operative time was 315 min. Postoperative complications with a Clavien-Dindo score >2 were observed in 13.5%. Obesity and low rectal tumors showed no significant higher rates of major complications or impaired oncological parameters. Male patients had significant higher rates of major complications and anastomotic leakage (p = 0.048 and p = 0.007, respectively). DISCUSSION: RRS is a promising tool for improvement of rectal resections. The well-known pitfalls of minimal-invasive rectal surgery like obesity and low tumors were sufficiently managed by RRS. However, RRS showed significantly higher rates of major complications and anastomotic leakage in male patients, which has to be evaluated by future randomized trials.

Assessing the role of primary tumour resection in patients with synchronous unresectable liver metastases from pancreatic neuroendocrine tumour of the body and tail. A propensity score survival evaluation.

BACKGROUND: The role of primary tumour surgery in pancreatic neuroendocrine tumours (PNETs) with unresectable liver metastases is controversial and international guidelines do not recommend surgery in such cases. Resectability of the primary tumour has never been considered in outcome comparisons between operated and non-operated patients. METHODS: From two institutional prospective databases of patients affected by PNET and unresectable liver metastases, 63 patients who underwent a left-pancreatectomy at diagnosis were identified and compared with a group of 30 patients with a potentially resectable but not-resected primary tumour located in the body or tail. The endpoint was overall survival (OS). RESULTS: The two groups significantly differed at baseline with regard to liver tumour burden Ki-67 labelling index, site of pancreas, results of the 18FDG PET-CT and age. In the operated patients, surgical morbidity comprised 7 cases of pancreatic fistula. Postoperative mortality was nil. Median OS for patients undergoing left-pancreatectomy was 111 months vs 52 for the non operated patients (p = 0.003). At multivariate analysis after propensity score adjustment, no surgery as well as liver tumour burden>25% and higher Ki-67 index were associated with an increased risk of death during follow-up. In patients with unresectable primary tumour, OS was similar in comparison to that in the resectable but non-resected patients, and significantly worse than that in the resected patients (p = 0.032). CONCLUSION: In PNETs located in the body or tail and diffuse liver metastases distal pancreatectomy may be justified in selected patients. Randomized studies may be safely proposed in future on this topic.

Robotic technology for colorectal surgery : Procedures, current applications, and future innovative challenges.

BACKGROUND: Colorectal cancer is the third most common cancer worldwide. Current treatment approaches are multidisciplinary, including neoadjuvant chemoradiotherapy for rectal cancer. Several studies have reported an improvement in surgical techniques and in new devices facilitating better pre- and intraoperative staging. OBJECTIVES: Since its first application in 2002, robotic surgery has progressed steadily, offering good surgical results and better oncological outcomes. Currently, many studies and reviews have confirmed its safety and feasibility for colorectal cancer. MATERIALS AND METHODS: Robotic technology simplifies surgical maneuvers thanks to the three-dimensional magnification and stable vision, convenient mobility of the robotic arms, endowrist instruments with seven degrees of freedom, ambidextrous capability, tremor filtering, and indocyanine green fluorescence imaging. RESULTS: Regarding the oncological outcome, the robotic technique is equivalent to the laparoscopic approach; however, a lower recurrence rate has been achieved with the robotic approach in extended lymphadenectomy as part of complete mesocolic excision for right colonic cancer and total mesorectal excision for low rectal tumors. CONCLUSION: Colorectal robotic surgery has progressively improved worldwide. Its advantages are related not only to better oncological outcomes, but also to improvements in terms of detection, accurate diagnosis, and staging.

[Robotic technology for colorectal surgery : Procedures, current applications, and future innovative challenges - German version]. / Robotertechnologie in der kolorektalen Chirurgie : Verfahren, aktuelle Anwendung und künftige innovative Herausforderungen.

BACKGROUND: Colorectal cancer is the third most common cancer worldwide. Current treatment approaches are multidisciplinary, including neoadjuvant chemoradiotherapy for rectal cancer. Several studies have reported an improvement in surgical techniques and in new devices facilitating better pre- and intraoperative staging. OBJECTIVES: Since its first application in 2002, robotic surgery has progressed steadily, offering good surgical results and better oncological outcomes. Currently, many studies and reviews have confirmed its safety and feasibility for colorectal cancer. MATERIAL AND METHODS: Robotic technology simplifies surgical maneuvers thanks to the three-dimensional magnification and stable vision, convenient mobility of the robotic arms, endowrist instruments with seven degrees of freedom, ambidextrous capability, tremor filtering and indocyanine green fluorescence imaging. RESULTS: Regarding the oncological outcome, the robotic technique is equivalent to the laparoscopic approach; however, a lower recurrence rate has been achieved with the robotic approach in extended lymphadenectomy as part of complete mesocolic excision for right colonic cancer and total mesorectal excision for low rectal tumors. CONCLUSION: Colorectal robotic surgery has progressively improved worldwide. Its advantages are related not only to better oncological outcomes, but also to improvements in terms of detection, accurate diagnosis and staging.

Challenges with robotic low anterior resection.

Dramatic improvements in the local recurrence rate of patients with rectal cancer have been observed after the introduction of the embriologically-based concept of total mesorectal excision by Heald more than 30 years ago. During the last decades, advances in multimodal treatment have further contributed to improve outcomes, but surgery still play a major role. Laparoscopic surgery for rectal cancer has been validated in randomized controlled trials to be oncologically as safe and effective as the open approach with better short-term postoperative outcomes. Nevertheless, laparoscopic low anterior resection continues to be challenging because of technical constraints and a steep learning curve. Robotic surgery may potentially offer significant advantages in rectal cancer surgery thanks to its technological features. This paper summarizes the current available evidence and highlights the most challenging aspects of robotic low anterior resection, with supporting data from the literature and from the authors' nearly ten-year experience in the field.

[Robotic rectal resection in rectal cancer: short term results in a monocentric prospective study]. / Trattamento chirurgico del cancro del retto con tecnica robotica: risultati a breve termine di uno studio prospettico monocentrico.

AIM: The aim of this study was to evaluate technical feasibility, oncological safety and short-term clinical results of robotic rectal resection for cancer. METHODS: From January 2008 to July 2010, 46 patients (27 males and 19 females, median age 69 years, median BMI 24.6 kg/m2) with histologically-proven adenocarcinoma of medium and distal rectum were enrolled in a prospective database. Preoperative assessment was performed with colonoscopy with biopsies, thoraco-abdominal CT scan, pelvic MRI and endorectal-ultrasound (ERUS). In the case of locally advanced non metastatic disease (T3/4 or N1/2), patients received preoperative radiotherapy (45 Grays in 5 weeks) and chemotherapy (oral Capecitabine). The robotic system was a four-arms Da Vinci® (Intuitive Surgical, Sunnyvale, CA, USA); arms position is not modified during the entire surgical procedure. RESULTS: Twenty-five patients received a preoperative radio-chemotherapy. Surgical procedure was an abdomino-perineal amputation in nine patients and an anterior resection in the remaining 37, with temporary ileostomy in 16 cases and a laparoscopic mobilization of splenic flexure in 25. Median operative time was 251 minutes, median time of first bowel movements 1.7 days and median hospital stay 6.7 days. Major complications requiring reoperation verified in 2 patients, while overall complication rate is 15.2%. Median number of harvested lymph nodes per patient was 18; median distance of the tumour from distal resection margin was 2 cm; distance of the tumour from circumferential margin was superior to 1 mm in all of the patients. At a median follow up of 11 months, all patients are alive and disease-free. CONCLUSION: Robotic rectal resection is a feasible technique which can provide good oncological and short-term clinical results.

Robotic versus laparoscopic total mesorectal excision for rectal cancer: a comparative analysis of oncological safety and short-term outcomes.

BACKGROUND: We assessed feasibility, short-term oncologic safety, and short-term outcomes in robotic total mesorectal excision (R-TME) for rectal cancer compared with laparoscopic TME. METHODS: From March 2008 to June 2009, 50 patients with proven middle/lower rectal adenocarcinoma underwent minimally invasive TME; 25 received R-TME. The groups were balanced (R-TME versus L-TME) in terms of age (median 69 versus 62 years; p = 0.8), disease stage, and body mass index (median 23 versus 26.5 kg/m(2); p = 0.06). There were 37 (74%) anterior resections and 13 (26%) abdominoperineal resections. Twenty-three (46%) patients received preoperative radiochemotherapy. The robot was a four-arm Da Vinci S (Intuitive Surgical, Sunnyvale, CA, USA). RESULTS: Median operating time (R-TME versus L-TME) was 240 versus 237 min (p = 0.2); first bowel movement was 2 versus 3 days (p = 0.5); median hospital stay was 6.5 versus 6 days (p = 0.4). Major complications with reoperation were two in R-TME (one anastomotic leakage, one small bowel perforation) and three in L-TME (one colonic ischemia, two anastomotic leakage). Postoperative complications were 16% versus 24% (p = 0.5). A median of 18 versus 17 (p = 0.7) lymph nodes were retrieved; distal resection margins were disease free in both groups; circumferential margin was involved (<1.0 mm) in one (4%) of L-TME. There were 0 versus 1 (5%) conversions to laparotomy. CONCLUSIONS: R-TME in rectal cancer is feasible, with short-term oncologic and other outcomes similar to those of L-TME. The greater maneuverability and visibility afforded by the robotic approach are attractive. Future studies should more systematically address advantages and costs of R-TME.

Integrated clinical-ultrasonographic diagnosis in acute appendicitis.

PURPOSE: Acute appendicitis is one of the commonest diseases encountered in the field of emergency surgery. If untreated, it can rapidly develop severe complications such as perforation and peritonitis. Surgeons therefore often choose early surgical treatment also when the diagnosis is only probable, facing the risk of performing an elevated amount of unnecessary appendectomies. The aim of this study is to analyse our experience with integrated clinical-ultrasonographic diagnosis in acute appendicitis. MATERIAL AND METHODS: From January 1999 to December 2006, 1447 patients underwent clinical examination, leucocyte count, evaluation of C-reactive protein level, and abdominal ultrasonography using graded compression technique and a high frequency probe. RESULTS: In 368 patients (25%) ultrasonographic diagnosis was acute appendicitis; 8 patients were operated on the basis of clinical evaluation only. Ultrasonography yielded false positive results in 7 cases. In 1079 patients (75%) diagnosis was negative for acute appendicitis; 173 of these patients (12%) received a different diagnosis. The remaining 906 patients underwent clinical follow-up until the symptoms disappeared; there were no complications. In our study, sensitivity of ultrasonography was 98%, specificity 99%, positive predictive value 98%, and negative predictive value 99%. Overall diagnostic accuracy was 99%. CONCLUSION: Integrated diagnosis of acute appendicitis based on clinical evaluation, laboratory tests and ultrasonography is safe and saves resources by preventing unnecessary operations.

[The use of metal vascular prosthesis in the palliative treatment of neoplastic esophago-gastric stenosis]. / Impiego di protesi metalliche vascolari nel trattamento palliativo delle stenosi neoplastiche esofago-gastriche.

The paper reports the authors' experience regarding the use of expandable metal prostheses designed for vascular stenoses but adapted for unoperable esophago-gastric stenoses. Their first impressions are very positive so much so that they affirm that these prostheses are close to being ideal since they are flexible and have an insertion diameter of 3 mm which does not therefore require dilatation. As a result: 1) they involve limited trauma to the patient; 2) reduce the risk of perforation to virtually zero. Moreover: 3) they can be inserted in twisted and angled stenoses and in esophaguses with difficult access due to axial deviations and restriction of the upper cervical aperture; 4) they function well even in notoriously "difficult" sections such as the cardia and esophago-jejunal anastomoses; 5) the unfastening system is easy and rapid. On the strength of these characteristics the authors suggest that these prostheses should be used in an outpatient setting, as occurred in the case of the last of the 10 patients treated, and even at a preoperative stage in preparation for resective surgery so as to preserve normal oral feeding. The structure of these prostheses renders them contraindicated for use in stenoses associated with fistulas in air paths and requires an evaluation of long-term results to verify the incidence with which the following occur: 1) tumoral growth between the mesh; 2) food obstruction; 3) hemorrhage due to compressive necrosis.(ABSTRACT TRUNCATED AT 250 WORDS)

Benign mixed salivary-type tumour of the breast.

A case of benign mixed salivary-type tumour of the breast is described. This is a rare neoplasm, only 20 cases having been reported to date, characterized by a mixture of epithelial and mesenchymal components, as in similar tumours occurring in the salivary glands and skin. Because this tumour frequently simulates carcinoma clinically, mammographically and histologically, familiarity of both the surgeon and pathologist with this lesion is essential, to avoid the overdiagnosis of malignancy, unfortunately initially made in nearly 50% of previously reported cases.

[Use of the rendez-vous technique in endoscopic insertion of biliary prosthesis in malignant obstructive jaundice]. / Impiego del rendez-vous per l'inserimento endoscopico di protesi biliari nell'ittero ostruttivo maligno.

The paper describes the Authors' personal experience of the use of the rendez-vous technique (using a combined endoscopic-transhepatic route) for the endoscopic insertion of biliary prosthesis in cases of malignant obstructive jaundice. Having illustrated the series of cases, the paper proposes the use of this technique in the event of endoscopic failure due to the smaller incidence of complications compared the use of a wholly transhepatic route.

[Carcinoma of the male breast in the province of Alessandria. Clinico-pathologic aspects of an 8-years' case load]. / Carcinoma della mammella maschile nella provincia di Alessandria. Aspetti clinico-patologici di una casistica di 8 anni.

The authors report their experience on male breast carcinoma based on a series of 16 cases diagnosed between 1981 and 1988 at the City Hospital of Alessandria. Main clinico-pathological findings are described and compared with those recorded in the relevant world literature. Emphasis is placed on the immunohistochemical evaluation of estrogen receptors and the frequency data of this uncommon cancer in hospital-based series are reviewed.

Expression of epidermal growth factor receptor in human breast carcinoma and its correlation with morphological and biological features of tumour aggressiveness.

A series of 54 patients presenting with primary breast cancer were investigated for tumour expression of epidermal growth factor receptor (EGFR) by the indirect three-step immunoperoxidase technique which used the monoclonal antibody EGFR1. The percentage of malignant cells positive for EGFR was determined and scored on a four-point (0-3) scale in each case. EGFR was demonstrated in 35 (64.8%) tumours. EGFR expression did not correlate (p greater than 0.05) with growth fraction immunohistochemically visualized by means of the monoclonal antibody Ki-67, tumour size, axillary lymph node status and malignancy grade. In contrast, a significant inverse relationship (p less than 0.05) was found between EGFR and estrogen receptor (ER) patterns. Expression of EGFR per se does not appear to be relevant to the biological behaviour of breast cancer as revealed through an evaluation of proliferative activity, pathological stage and histological differentiation. Recognition that EGFR is negatively related to ER supports the present evidence that the control of malignant cell growth and differentiation depends on complex regulatory mechanisms in which several extracellular messenger molecules, including hormones and peptide growth factors together with their specific cellular receptors, are involved and inextricably interwoven.

[Type III entrapment syndrome of the popliteal artery. Presentation of a clinical case with diagnostic and therapeutic discussion]. / Sindrome da "entrapment" della poplitea tipo III. Presentazione di un caso clinico con discussione diagnostica e terapeutica.

Following a short review of the various types of possible abnormalities in the popliteal artery entrapment syndrome, a case is presented which was misdiagnosed for more than 2 years. Problems concerning the differential diagnosis are discussed together with details of the surgical approach performed using the medial incision and the PTFE prosthesis.