A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial).

BACKGROUND: Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials. METHOD: This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis. RESULTS: Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available. CONCLUSIONS: Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison. Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.

Complete mesocolic excision in comparison with conventional surgery for right colon cancer: a nationwide multicenter study of the Italian Society of Surgical Oncology colorectal cancer network (CoME-in trial). Study protocol for a randomized controlled trial.

Complete mesocolic excision with central vascular ligation, or simply CME, includes the sharp dissection along the mesocolic visceral and parietal layers, with the ligation of the main vessels at their origins. To date, there is low evidence on its safety and efficacy. This is a study-protocol of a multicenter, randomized, superiority trial in patients with right-sided colon cancer. It aims to investigate whether the complete mesocolic excision improves the oncological outcomes as compared with conventional right hemicolectomy, without worsening early outcomes. Data on efficacy and safety of complete mesocolic excision are available only from a large trial recruiting eastern patients and from a low-volume single-center western study. No results on survival are still available. For this reason, complete mesocolic excision continues to be a controversial topic in daily practice, particularly in western world. This new nationwide multicenter large-volume trial aims to provide further data on western patients, concerning both postoperative and survival outcomes.

Neoadjuvant chemotherapy for gastric cancer. Is it a must or a fake?

AIM: To investigate the neoadjuvant chemotherapy (NAC) effect on the survival of patients with proper stomach cancer submitted to D2 gastrectomy. METHODS: We proceeded to a review of the literature with PubMed, Embase, ASCO and ESMO meeting abstracts as well as computerized use of the Cochrane Library for randomized controlled trials (RCTs) comparing NAC followed by surgery (NAC + S) with surgery alone (SA) for gastric cancer (GC). The primary outcome was the overall survival rate. Secondary outcomes were the site of the primary tumor, extension of node dissection according to Japanese Gastric Cancer Association (JGCA) performed in both arms, disease-specific (DSS) and disease-free survival (DFS) rates, clinical and pathological response rates and resectability rates after perioperative treatment. RESULTS: We identified a total of 16 randomized controlled trials comparing NAC + S (n = 1089) with SA (n = 973) published in the period from January 1993 - March 2017. Only 6 of these studies were well-designed, structured trials in which the type of lymph node (LN) dissection performed or at least suggested in the trial protocol was reported. Two out of three of the RCTs with D2 lymphadenectomy performed in almost all cases failed to show survival benefit in the NAC arm. In the third RCT, the survival rate was not even reported, and the primary end points were the clinical outcomes of surgery with and without NAC. In the remaining three RCTs, D2 lymph node dissection was performed in less than 50% of cases or only recommended in the "Study Treatment" protocol without any description in the results of the procedure really perfomed. In one of the two studies, the benefit of NAC was evident only for esophagogastric junction (EGJ) cancers. In the second study, there was no overall survival benefit of NAC. In the last trial, which documented a survival benefit for the NAC arm, the chemotherapy effect was mostly evident for EGJ cancer, and more than one-fourth of patients did not have a proper stomach cancer. Additionally, several patients did not receive resectional surgery. Furthermore, the survival rates of international reference centers that provide adequate surgery for homogeneous stomach cancer patients' populations are even higher than the survival rates reported after NAC followed by incomplete surgery. CONCLUSION: NAC for GC has been rapidly introduced in international western guidelines without an evidence-based medicine-related demonstration of its efficacy for a homogeneous population of patients with only stomach tumors submitted to adequate surgery following JGCA guidelines with extended (D2) LN dissection. Additional larger sample-size multicentre RCTs comparing the newer NAC regimens including molecular therapies followed by adequate extended surgery with surgery alone are needed.

Surgeon's clinical valuation and accuracy of ultrasound in the diagnosis of acute appendicitis: A comparison with intraoperative evaluation. Five years experience.

INTRODUCTION: Acute appendicitis is the most common cause of acute abdomen in adolescents, with an overall incidence of 7%. Two such tools are used to diagnose acute appendicitis: ultrasound and Computer Tomography imaging. End point of this study was to verify the accuracy of ultrasound imaging in the diagnosis of acute appendicitis with respect to intraoperative observations and the respective clinical and laboratory findings in young and in the elderly. METHODS: We considered all the appendectomies for acute appendicitis performed between 1 January 2010 and 1 January 2015. We evaluated clinical symptoms, laboratory findings, ultrasound findings, intraoperative signs, and anatomical and pathological findings. In the study we compared the ultrasound and intraoperative findings and then compared these with the respective clinical and laboratory data. RESULTS: In a comparison of diagnostic accuracy, the difference between clinical and ultrasound examinations was not significant. The differences between the diagnostic accuracy of clinical and laboratory findings and between ultrasound and laboratory investigations were statistically significant. CONCLUSION: We defined white blood cells and C protein levels as non-diagnostic of the type of acute inflammation but rather as indicators of the severity of the inflammatory process. We also agree with the authors who proposed the incorporation of ultrasonography into routine practice in the diagnosis of acute appendicitis, but only and exclusively to support other diagnostic procedures and preferably within emergency departments. A thorough clinical examination of patients with suspected acute appendicitis is still the best diagnostic procedure available to us.

Laparoscopic management of non-midline incisional hernia: A multicentric study.

BACKGROUND: The laparoscopic repair of non-midline ventral hernia (LNM) has been debated. The aim of this study is to analyze our experience performing the laparoscopic approach to non-midline ventral hernias (NMVHs) in Northwest Italy for 6 years. METHODS: A total of 78 patients who underwent LNM between March 2008 and March 2014 in the selected institutions were analyzed. We retrospectively analyzed the peri- and postoperative data and the recurrence rate of four subgroups of NMVHs: subcostal, suprapubic, lumbar, and epigastric. We also conducted a literature review. RESULTS: No difference was found between the four subgroups in terms of demographic data, defect characteristics, admission data, and complications. Subcostal defects required a shorter operating time. Obesity was found to be a risk factor for recurrence. CONCLUSIONS: In our experience, subcostal defects were easier to perform, with a lower recurrence rate, lesser chronic pain, and faster surgical performance. A more specific prospective randomized trial with a larger sample is awaited. Based on our experience, however, the laparoscopic approach is a safe treatment for NMVHs in specialized centers.

Management of venous ulcers: State of the art.

Venous ulceration is a complex and serious problem that affects 1-2% of the global elderly population (>65 years), and its incidence is constantly increasing. The population group with higher risk of development of venous ulceration is the elderly. These lesions have a significant negative impact on patients' quality of life. Our aim was to analyze the state of the art, starting with the medical literature review. The evidence supports that managing chronic wounds with a multidisciplinary wound care team significantly increases wound healing and reduces the severity of wound-associated pain and the required daily wound treatments compared with persons who are not managed by such a team.

Learning curve for endorectal ultrasound in young and elderly: lights and shades.

Aim of the study is to highlight difficulties faced by an inexperienced surgeon in approaching endorectal-ultrasound, trying to define when learning curve can be considered complete. A prospective analysis was conducted on endorectal-ultrasound performed for subperitoneal rectal adenocarcinoma staging in the period from January 2008 to July 2013, reported by a single surgeon of Department of Oncology, Section of General Surgery, "San Luigi Gonzaga" Teaching Hospital, Orbassano (Turin, Italy); the surgeon had no previous experience in endorectal-ultrasound. Fourty-six endorectal-ultrasounds were divided into two groups: early group (composed by 23 endorectal-ultrasounds, made from January 2008 to May 2009) and late group (composed by 23 endorectal-ultrasound, carried out from June 2009 to July 2013). In our experience, the importance of a learning curve is evident for T staging, but no statystical significance is reached for results deal with N stage. We can conclude that ultrasound evaluation of anorectal and perirectal tissues is technically challenging and requires a long learning curve. Our learning curve can not be closed down, at least for N parameter.

The learning curve of laparoscopic holecystectomy in general surgery resident training: old age of the patient may be a risk factor?

A well-designed learning curve is essential for the acquisition of laparoscopic skills: but, are there risk factors that can derail the surgical method? From a review of the current literature on the learning curve in laparoscopic surgery, we identified learning curve components in video laparoscopic cholecystectomy; we suggest a learning curve model that can be applied to assess the progress of general surgical residents as they learn and master the stages of video laparoscopic cholecystectomy regardless of type of patient. Electronic databases were interrogated to better define the terms "surgeon", "specialized surgeon", and "specialist surgeon"; we surveyed the literature on surgical residency programs outside Italy to identify learning curve components, influential factors, the importance of tutoring, and the role of reference centers in residency education in surgery. From the definition of acceptable error, self-efficacy, and error classification, we devised a learning curve model that may be applied to training surgical residents in video laparoscopic cholecystectomy. Based on the criteria culled from the literature, the three surgeon categories (general, specialized, and specialist) are distinguished by years of experience, case volume, and error rate; the patients were distinguished for years and characteristics. The training model was constructed as a series of key learning steps in video laparoscopic cholecystectomy. Potential errors were identified and the difficulty of each step was graded using operation-specific characteristics. On completion of each procedure, error checklist scores on procedure-specific performance are tallied to track the learning curve and obtain performance indices of measurement that chart the trainee's progress. CONCLUSIONS: The concept of the learning curve in general surgery is disputed. The use of learning steps may enable the resident surgical trainee to acquire video laparoscopic cholecystectomy skills proportional to the instructor's ability, the trainee's own skills, and the safety of the surgical environment. There were no patient characteristics that can derail the methods. With this training scheme, resident trainees may be provided the opportunity to develop their intrinsic capabilities without the loss of basic technical skills.

Self-gripping mesh versus fibrin glue fixation in laparoscopic inguinal hernia repair: a randomized prospective clinical trial in young and elderly patients.

Laparoscopic transabdominal preperitoneal inguinal hernia repair is a safe and effective technique. In this study we tested the hypothesis that self-gripping mesh used with the laparoscopic approach is comparable to polypropylene mesh in terms of perioperative complications, against a lower overall cost of the procedure. We carried out a prospective randomized trial comparing a group of 30 patients who underwent laparoscopic inguinal hernia repair with self-gripping mesh versus a group of 30 patients who received polypropylene mesh with fibrin glue fixation. There were no statistically significant differences between the two groups with regard to intraoperative variables, early or late intraoperative complications, chronic pain or recurrence. Self-gripping mesh in transabdominal hernia repair was found to be a valid alternative to polypropylene mesh in terms of complications, recurrence and postoperative pain. The cost analysis and comparability of outcomes support the preferential use of self-gripping mesh.

Anal sphincter dysfunction in multiple sclerosis: an observation manometric study.

Constipation, obstructed defecation, and fecal incontinence are frequent complaints in multiple sclerosis. The literature on the pathophysiological mechanisms underlying these disorders is scant. Using anorectal manometry, we compared the anorectal function in patients with and without multiple sclerosis. 136 patients referred from our Center for Multiple Sclerosis to the Coloproctology Outpatient Clinic, between January 2005 and December 2011, were enrolled. The patients were divided into four groups: multiple sclerosis patients with constipation (group A); multiple sclerosis patients with fecal incontinence (group B); non-multiple sclerosis patients with constipation (group C); non-multiple sclerosis patients with fecal incontinence (group D). Anorectal manometry was performed to measure: resting anal pressure; maximum squeeze pressure; rectoanal inhibitory reflex; filling pressure and urge pressure. The difference between resting anal pressure before and after maximum squeeze maneuvers was defined as the change in resting anal pressure calculated for each patient. RESULTS: Group A patients were noted to have greater sphincter hypotonia at rest and during contraction compared with those in group C (p=0.02); the rectal sensitivity threshold was lower in group B than in group D patients (p=0.02). No voluntary postcontraction sphincter relaxation was observed in either group A or group B patients (p=0.891 and p=0.939, respectively). CONCLUSIONS: The decrease in the difference in resting anal pressure before and after maximum squeeze maneuvers suggests post-contraction sphincter spasticity, indicating impaired pelvic floor coordination in multiple sclerosis patients. A knowledge of manometric alterations in such patients may be clinically relevant in the selection of patients for appropriate treatments and for planning targeted rehabilitation therapy.

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

BACKGROUND: Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. METHODS: This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. RESULTS: Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. CONCLUSIONS: Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

Abdominal compartment syndrome and open abdomen management with negative pressure devices.

BACKGROUND: Abdominal compartment syndrome (ACS) is defined as an increase of intra-abdominal pressure (IAH) to values higher than 20 mmHg, associated with reduced perfusion and organ dysfunction. MATERIALS AND METHODS: There is a classification of open abdomen which stratifies patients according to the natural history of improvement or clinical deterioration. The aim of treatment is to maintain the open abdomen at the lowest level and to prevent progression to a more complex level. DISCUSSION: Surgical treatment essentially consists in abdominal decompression by leaving the abdomen open. Analysis of the literature shows that negative pressure increases the rate of primary fascial closure; entero-cutaneous fistulas are seen in a minority of cases, without seeming consequence of the application of the dressing. Open abdomen management consists of three treatment stages: acute (24-48 hours), intermediate (from 48 hours to 10 days) and late or reconstruction (from 10 days to the final closure). CONCLUSION: It's important to recognize patients at risk of IAH and the first signs of ACS and intervene early with abdominal decompression if this will establish itself. Management of the open abdomen is now facilitated by negative pressure devices, which positively affect the morbidity and mortality of patients with ACS.

An unusual evolution of a case of Klippel-Trenaunay syndrome.

Klippel-Trenaunay syndrome (KTS) is a rare congenital disorder. KTS can be diagnosed on the basis of any 2 of 3 features: cutaneous capillary malformations, soft tissue or bony hypertrophy and varicose veins. We present an unusual case of KTS complicated by an infection of venous ulcers of the lower limb by larvae. The treatment of infection was a complete debridement; however baseline treatment of KTS is still in evaluation.

Abnormal right hepatic artery injury resulting in right hepatic atrophy: diagnosed by laparoscopic cholecystectomy.

An intact hepatic artery is the gateway to successful hepato-biliary surgery. Introduction of laproscopic cholecystectomy (LC) has stimulated a renewed interest in the anatomy of hepatic artery. In this case report we have highlighted importance of variations of right hepatic artery in terms of origin and course We present a rare asymptomatic case of liver atrophy due to an intraoperative lesion of right hepatic artery. We also performed a literature review about surgical vascular lesions and tried to confirm the right concept behind "non trivial procedure" of the LC.

Difficult abdominal access in laparoscopic cholecystectomy in elderly patients: our experience and literature review.

Laparoscopic cholecystectomy (LC) is currently the gold standard treatment for symptomatic cholelithiasis. LC is actually condidered a medium complexity surgical operation. LC could be technically hard, especially if patient underwent previous surgical operation. These difficulties increase in outcome of previous operation in right upper quadrant (RUQ): in this case laparoscopic access is defined as an "hard access". We present two cases in which an unconventional access was performed: laparoscopic cholecistectomy is a safe and feasible procedure, although a careful assessment preoperative is indispensable. In particular, caution is required in both the triangulation of the trocar, which in pneumoperitoneum induction.

Fibrin glue versus stapler fixation in laparoscopic transabdominal inguinal hernia repair: a single center 5-year experience and analysis of the results in the elderly.

INTRODUCTION: Inguinal hernia surgery is one of the most common surgical procedures performed worldwide. Some studies demonstrated clear advantages of laparoscopic approach in terms of chronic pain, recurrence rate and daily life activities Aim of this study was to compare short and long-terms outcome of tacks and fibrin glue used during laparoscopic transabdominal hernioplasty (TAPP). METHODS: This is a retrospective study conducted by our division of General Surgery. From May 2008 to May 2013 we performed 116 hernioplasty with TAPP technique. We compared two groups of patients: a group of 59 patients treated with fibrin glue and a group of 57 patients treated with conventional tacks and the two subgroups of patients over 65 years old. We evaluated: perioperative outcomes, early and late complications. RESULTS: There were no significative difference about length of postoperative stay, time to return to work, recurrence rate and complications. DISCUSSION: This study demonstrates that fibrin glue are same tolerated than tacks by patients and that the glues lead to the same good results during initial follow-up and in long term data also in the elderly. Meticulous preparation of the groin with preservation of spermatic sheet is in our opinion necessary to provide effective pain reduction and a good result in every TAPP procedure.

Percutaneous drainage and sclerosis of mesenteric cysts: literature overview and report of an innovative approach.

We present the case of a 29-years-old male patient, affected by a voluminous post-traumatic mesenteric cyst, a rare abdominal disease; our patient represents a rarely affected age group. Treatment was based on interventional radiology with an US-guided drainage and sclerosis by ethyl alcohol of the lesion. The intervention performed on this patient represents the application of a standardized radiological technique to a new contest, mesenteric cysts, whose gold-standard treatment is represented in literature by surgery. In our case we obtained an optimal result, with complete regression of the treated cyst: it proved to be an effective, feasible, safe and minimally invasive procedure.

Endorectal ultrasound in the diagnosis of rectal cancer: accuracy and criticies.

INTRODUCTION: Endorectal ultrasound (ERU) is used for locoregional staging of rectal cancer. Our work compares the data in the literature regarding diagnostic accuracy of the technique and results of routine use of the technique in two centers in Piedmont. MATERIAL AND METHODS: 77 reports ultrasound with the final diagnosis of rectal cancer from the period 2008-2012 were examined. The echographies were performed by two experienced operators, using two ultrasound device with the same technical characteristics. RESULTS: Sensitivity levels are high, with the exception of stage T3. Specificity is always high. The relationships of verisimilitude, both negative and positive, showing that the accuracy of the test is still high. The risk of overstaging is higher for pT1, while most important the risk of understaging concerns the stage T3 (23.5%); on the contrary the ERU is able to exclude infiltration of perirectal organs with a good accuracy (NPV of 99.3%). CONCLUSION: Although our study was a retrospective study, likewise some literature's reports, the interpretation of our analysis results shows a significant risk of downstaging T3 and N+ tumors. ERU represents in our experience a very important radiological staging methods to evaluate T1 and T2 rectal cancer.

Perioperative and postoperative outcomes of perforated diverticulitis Hinchey II and III: open Hartmann's procedure vs. laparoscopic lavage and drainage in the elderly.

Hartmann's procedure (HP) is the most performed technique for acute diverticulitis. Laparoscopic lavage and drainage (LLD) is an option evaluated as definitive treatment for diverticulitis Hinchey grade II-III. Aim of the study is to analyze and compare LLD vs HP outcomes. From January 1st 2009 and December 31st 2012 we prospectively enrolled 30 patients with diagnosis of acute diverticulitis Hinchey grade II-III. Fourteen patients underwent to LLD (LLD group, LLDG) and 16 patients to HP (Hartmann group, HG). We evaluated: demographic variables, comorbidities, admission clinical status, radiological imaging, intraoperative outcomes (operative time), postoperative outcomes (admission to ICU, timing of drainage removal, restore of bowel functions, timing of oral solid intake), mortality rate (perioperative and after 12 months) and morbidity rate (surgical, infectious, cardiovascular, renal and systemic complications). Exclusion criteria were: other diseases, colon cancer's suspect or diagnosis, conversion to HP. Patients' mean age was 64.8 years in HG and 62.6 in LLDG. M:F ratio was 6:10 in HG, 8:6 in LLDG. Data showed improved outcomes in LLDG for: total operative time (p < 0.0001), admission to ICU (p 0.0447), restoration of bowel functions (p 0.0035 for gases, p 0.0152 for feces), mobilization (p 0.0087) and length of hospital stay (p 0.0132). According to literature, LLD is related to operative risk, morbidity and mortality rate and length of stay lower than HP. LLD also gives the possibility to avoid stoma. Despite limits of our study, we consider LLD as a "safe and effective" treatment for Hinchey grade II-III acute diverticulitis.