Early diagnosis of anastomotic leakage after colorectal surgery by the Dutch leakage score, serum procalcitonin and serum C-reactive protein: study protocol of a prospective multicentre observational study by the Italian ColoRectal Anastomotic Leakage (iC.

BACKGROUND: Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. There is no uniform definition of anastomotic dehiscence and leak. Over the years many risk factors have been identified (distance of anastomosis from anal verge, gender, BMI, ASA score) but none of these allows an early diagnosis of AL. The DUtch LeaKage (DULK) score, C reactive protein (CRP) and procalcitonin (PCT) have been identified as early predictors for anastomotic leakage starting from postoperative day (POD) 2-3. The study was designed to prospectively evaluate AL rates after colorectal resections, in order to give a definite answer to the need for clear risk factors, and testing the diagnostic yeld of DULK score and of laboratory markers. Methods and analysis. A prospective enrollment for all patients undergoing elective colorectal surgery with anastomosis carried out from September 2017 to September 2018 in 19 Italian surgical centers. OUTCOME MEASURES: preoperative risk factors of anastomotic leakage; operative parameters; leukocyte count, serum CRP, serum PCT and DULK score assessment on POD 2 and 3. Primary endpoint is AL; secondary endpoints are minor and major complications according to Clavien-Dindo classification; morbidity and mortality rates; readmission and reoperation rates, length of postoperative hospital stay (Retrospectively registered at ClinicalTrials.gov Identifier: NCT03560180, on June 18, 2018). Ethics. The ethics committee of the "Comitato Etico Regionale delle Marche - C.E.R.M." reviewed and approved this study protocol on September 7, 2017 (protocol no. 2017-0244-AS). All the participating centers submitted the protocol and obtained authorization from the local Institutional Review Board.

ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures.

BACKGROUND: The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment. METHODS: Consecutive patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal surgery-related conversion and complications. RESULTS: Some 1769 patients were enrolled, 937 with benign and 832 with malignant conditions. Procedures were completed without additional trocars in 1628 patients (92·0 per cent). Conversion to open surgery was required in 75 patients (4·2 per cent) and was related to male sex and ASA fitness grade exceeding I. Conversions were more frequent in pelvic procedures involving the rectum compared with abdominal procedures (8·1 versus 3·2 per cent; odds ratio 2·69, P < 0·001). Postoperative complications were observed in a total of 224 patients (12·7 per cent). Independent predictors of complications included male sex (P < 0·001), higher ASA grade (P = 0·006) and rectal procedures (P = 0·002). The overall 30-day mortality rate was 0·5 per cent (8 of 1769 patients); three deaths (0·2 per cent; 1 blood loss, 2 leaks) were attributable to surgical causes. CONCLUSION: The feasibility and safety, conversion and complication profile demonstrated here provides guidance for patient selection.

Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study.

BACKGROUND: Rectum-sparing approaches appear to be appropriate in rectal cancer patients with a major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The aim of the present study is to evaluate the effectiveness of rectum-sparing approaches at 2 years after the completion of neoadjuvant treatment. STUDY DESIGN: Patients with rectal adenocarcinoma eligible to receive neoadjuvant therapy will be prospectively enrolled. Patients will be restaged 7-8 weeks after the completion of neoadjuvant therapy and those with mCR (defined as absence of mass, small mucosal irregularity no more than 2 cm in diameter at endoscopy and no metastatic nodes at MRI) or cCR will be enrolled in the trial. Patients with mCR will undergo local excision, while patients with cCR will either undergo local excision or watch and wait policy. The main end point of the study is to determine the percentage of rectum preservation at 2 years in the enrolled patients. CONCLUSION: This protocol is the first prospective trial that investigates the role of both local excision and watch and wait approaches in patients treated with neoadjuvant therapy for rectal cancer. The trial is registered at clinicaltrials.gov (NCT02710812).

T1 colon cancer in the era of screening: risk factors and treatment.

BACKGROUND: The aim of this study was to identify risk factors for lymph node positivity in T1 colon cancer and to carry out a surgical quality assurance audit. METHODS: The sample consisted of consecutive patients treated for early-stage colon lesions in 15 colorectal referral centres between 2011 and 2014. The study investigated 38 factors grouped into four categories: demographic information, preoperative data, indications for surgery and post-operative data. A univariate and multivariate logistic regression analysis was performed to analyze the significance of each factor both in terms of lymph node (LN) harvesting and LN metastases. RESULTS: Out of 507 patients enrolled, 394 patients were considered for analysis. Thirty-five (8.91%) patients had positive LN. Statistically significant differences related to total LN harvesting were found in relation to central vessel ligation and segmental resections. Cumulative distribution demonstrated that the rate of positive LN increased starting at 12 LN harvested and reached a plateau at 25 LN. CONCLUSIONS: Some factors associated with an increase in detection of positive LN were identified. However, further studies are needed to identify more sensitive markers and avoid surgical overtreatment. There is a need to raise the minimum LN count and to use the LN count as an indicator of surgical quality.

A narrative review of the construct of hedonic hunger and its measurement by the Power of Food Scale.

INTRODUCTION: The term 'hedonic hunger' refers to one's preoccupation with and desire to consume foods for the purposes of pleasure and in the absence of physical hunger. The Power of Food Scale (PFS) was developed as a quantitative measure of this construct in 2009. Since then, over 50 published studies have used the PFS to predict appetite-related outcomes including neural, cognitive, behavioural, anthropometric and clinical measures. OBJECTIVE: This narrative review evaluates how closely the PFS captures the construct it was originally presumed to assess and to more clearly define hedonic hunger itself. METHODS: The measure's relationship to four domains is reviewed and summarized: motivation to consume palatable foods; level of actual consumption of such foods; body mass; and subjective loss-of-control over one's eating behaviour. Findings are synthesized to generate a more accurate understanding of what the PFS measures and how it may relate to the broader definition of hedonic hunger. RESULTS: Results suggest that the PFS is closely related to motivation to consume palatable foods and, in extreme cases, occurrence of loss-of-control eating episodes. PFS scores are not consistently predictive of amount of food consumed or body mass. CONCLUSIONS: Implications of these findings are discussed in the context of behavioural health, and avenues for further inquiry are identified.

Liver resection for large-size hepatocellular carcinomas in 47 non-cirrhotic patients--no mortality and long-term survival.

BACKGROUND/AIMS: Few reports have analyzed short- and long-term outcomes in the subset of patients with hepatocellular carcinoma (HCC) on non-cirrhotic liver. METHODOLOGY: From January 1985 to December 2002, 277 patients underwent liver resection for HCC; in only 47 the liver was normal or showed mild chronic hepatitis at histology. RESULTS: A major hepatectomy (MHR) was accomplished in 37 cases (78.7%) including an extended hepatic resection in 18 (38.3%). In-hospital mortality was nil. The rate of complications was 40.4%. Overall and disease-free survival rates at 5 years were 30.9% and 33.9%. Fifteen patients are actually alive with a median survival of 33.3 months. By multivariate analysis, tumor size > 10cm and presence of satellite nodules were independent predictive factors of 5-year survival; median survival of thirteen patients with HCCs < or = 10cm and without daughter nodules was 60 months. Twenty-six patients had a margin less than 1cm and without cancer involvement; overall and recurrence-free survival rates were comparable to those of the patients with a > 1cm margin. CONCLUSIONS: In the treatment of HCC without cirrhosis, major hepatic resections are often needed. Tumors less than 10cm in size and without satellite nodes are the best candidates for operation. The width of the resection margin is unimportant provided that there is no microscopic infiltration.

Liver resection for hepatocellular carcinoma on cirrhosis: analysis of mortality, morbidity and survival--a European single center experience.

AIMS: To evaluate short- and long-term results of liver resections and prognostic factors in cirrhotic patients with hepatocellular carcinoma. STUDY DESIGN: A single-unit, retrospective study analyzing 216 patients with histologically confirmed cirrhosis who underwent hepatic resection for hepatocellular carcinoma. All clinico-pathologic and follow-up data were collected prospectively. RESULTS: Child A patients had a significantly lower in-hospital mortality rate compared to Child B-C: 4.7 vs 21.3% (p=0.0003). Overall morbidity rate was 38.4%; multiple logistic regression analysis identified liver function, hepatic pedicle clamping time, number of nodes and transfusion rate as independent predictors for post-operative complications. Overall and disease-free 5-year survival rates were 34.1 and 25.2%. Multivariate analysis showed that Child A, radical resection, tumour size < or =5 cm and, absence of vascular invasion were independent prognostic factors for long-term survival. No significant differences in overall and disease-free survival were found according to the type of resection (anatomic vs non-anatomic). CONCLUSIONS: Patients with preserved liver function and small-size, single-node hepatocellular carcinomas are the best candidates for hepatic resection.

Transanal total mesorectal excision (taTME) for cancer located in the lower rectum: short- and mid-term results.

BACKGROUND: Laparoscopic trans-abdominal total mesorectal excision is technically demanding. Transanal Total Mesorectal Excision (taTME) is a new technique which seems to provide technical advantages. This study describes the results of taTME in a consecutive series of patients with low rectal cancer. METHODS: From January 2012 to December 2013, a consecutive series of 26 patients with low rectal cancer underwent laparoscopic taTME with coloanal anastomosis. cT4 or Type II-III rectal cancer (according to Rullier's classification) were contraindications to taTME. After anal sleeve mucosectomy, the rectal wall was transected at the ano-rectal junction. A single-access multichannel port was inserted in the anal canal. taTME was performed from down to up until the sacral promontory posteriorly and the Pouch of Douglas anteriorly were reached. A laparoscopic trans-abdominal approach was used to complete the left colon mobilization. RESULTS: Sixteen patients (61.5%) were male. The mean distance of the rectal cancer from the anal verge was 4.4 cm (range 3-6). Nineteen patients (73.1%) received long-course neoadjuvant radiotherapy. At final pathology, resection margins were negative in all the patients: the mean distal and radial resection margins were 19 mm and 11.2 mm, respectively. TME was complete in 23 patients (88.5%) and nearly complete in three. Postoperative mortality was 3.8%. The overall morbidity rate was 26.9% (7 patients): two patients (7.7%) had an anastomotic leakage (Dindo I-d). After a mean follow up of 23 months, no patients have developed a local recurrence. CONCLUSIONS: laparoscopic taTME allow wide resection margins and good quality TME.

Measurement of the mechanical properties of the ovine anterior cruciate ligament bone-ligament-bone complex: a basis for prosthetic evaluation.

The reported ultimate tensile stress of the anterior cruciate ligament varies greatly, ranging from 13 to 147 MPa. This study shows that the orientation and degree of flexion of the bone-ligament-bone complex significantly alter the apparent ultimate tensile properties (ultimate tensile stress ranging from 60 +/- 3 to 123 +/- 15 MPa, ultimate specific extension from 37 +/- 7 to 93 +/- 20%), whilst the method chosen for measuring extension also affects the calculated specific extension of the bone-ligament-bone complex. It is suggested that, for considerations of prosthesis design and evaluation, the mechanical properties of the bone-ligament-bone complex should be measured in anterior draw and extension measured using points as close as possible to the positions of the ligamentous attachment sites.

Radical surgery for gallbladder cancer: current options.

Gallbladder carcinoma is the most common malignancy of the biliary tract. There are still many controversies regarding the type of curative surgical treatment for each stage of the disease. The staging system used is the TNM classification of the International Union Against Cancer. Different patterns of spread characterize gallbladder cancer but the two main types are direct invasion and lymph node metastases; since only the depth of invasion can be easily recognized by imaging techniques, it becomes the main variable in choosing the appropriate surgical treatment. Most Tis and T1 tumours are incidentally discovered after cholecystectomy for cholelithiasis and no further therapy is requested; for pT1b tumours, relaparotomy with hepatic resection and N1 dissection is associated with a better survival. For T2 tumours, cholecystectomy with hepatic resection and dissection of N1-2 lymph nodes is the standard treatment, with a 5-year survival of 60-80%. The only chance of long-term survival for patients with a T3-T4 tumour is an extended operation combining an hepatic resection with an N1-2 dissection with or without excision of the common bile duct. A subset of patients with peripancreatic positive nodes or invasion of adjacent organs seems to benefit from a synchronous pancreaticoduodenectomy.

Radical surgery for gallbladder cancer: a worthwhile operation?

AIMS: Extended operations are the only chance of a cure for patients with advanced gallbladder carcinoma, but there is no consensus about which subset of patients can benefit. The aim of this retrospective study is to evaluate the results of surgical resection with special reference to the prognostic factors and to long-term survival. METHODS: A retrospective review of 70 patients with a diagnosis of gallbladder cancer treated from 1985-1998 was performed: 33 patients had a curative resection and were included in this study. For stage I disease, simple cholecystectomy was considered curative; in most of the other cases, cholecystectomy was associated with lymph node dissection and liver resection. RESULTS: Hospital mortality and morbidity were 6% and 33%, respectively. Curative resection was associated with an actuarial 5-year survival of 27.4%. Survival of pT1-2 patients was significantly better than that of pT3 (P=0.04) or pT4 patients (P=0.002). Patients with lymph node spread had a poorer prognosis (P=0.06) but four were alive and disease-free with a median survival of 22 months. CONCLUSIONS: Depth of the tumour and lymph node metastases are important prognostic factors. Patients with pT3-4 tumours or regional lymph node spread should be considered for curative resection because long-term survival is possible.

Spontaneous rupture of hepatocelluar carcinoma: surgical resection and long-term survival.

AIMS: Spontaneous rupture of hepatocellular carcinoma (HCC) is a life-threatening event, particularly in patients with associated cirrhosis. We present our experience of hepatic resection of ruptured HCC. METHODS: We performed 199 resections of hepatocellular carcinoma between January 1984 and December 1999. Six (3%) of these patients were operated on as an emergency because of haemoperitoneum: in five the liver was cirrhotic. RESULTS: The mean duration of the operation was 195+/-101 min; all the patients received blood transfusions. The overall morbidity was 50%, with a mortality rate of 16.5%. Three patients were alive at 50, 80 and 116 months respectively; two had an intrahepatic recurrence treated by chemoembolization. CONCLUSIONS: Non-surgical treatment of spontaneously ruptured hepatocarcinoma should be performed only in patients with contraindication to surgery. Hepatic resection should be the treatment of choice since, according to our experience, long-term results are similar to those of elective surgery.

Laparoscopy as a prognostic factor in curative resection for node positive colorectal cancer: results for a single-institution nonrandomized prospective trial.

BACKGROUND: Several studies reporting preliminary long-term survival data after laparoscopic resections for colonic adenocarcinoma did not show any detrimental effect in comparison with historic studies of laparotomies. A previous randomized study has reported an unforeseen better long-term survival for node-positive patients treated by laparoscopic colectomy. METHODS: A single-institution prospective nonrandomized trial compared short- and long-term results of laparoscopic and open curative resection for adenocarcinoma of the left colon or rectum in 255 consecutive patients from January 1996 to December 2000. RESULTS: In this study, 34 left hemicolectomy, 202 anterior resections, and 19 abdominoperineal resections were performed. A total of 74 patients underwent a laparoscopic resection (LR), and 181, an open resection (OR). The tumor site was the descending colon in 32 cases, the sigmoid colon in 98 cases, and the rectum in 125 cases, including 87 mid-low rectal cancers. Ten LR procedures (13.5%) were converted to open surgery. The hospital mortality was 0.08%, and in hospital morbidity was 16.2% for LR and 13.3% for OR (p = 0.56). The median postoperative stay was 1 day shorter for LR (9 days) than for OR (10 days) (p = 0.09). The mean number of lymph nodes retrieved were 13.8 +/- 5.7 for OR and 12.7 +/- 5; for LR (p = 0.23). Age exceeding 70 years, T stage, N stage, grading, mid-low rectal site, and laparoscopy were found by multivariate analysis to be significant prognostic factors for disease-free and cancer-related survival. When patients were stratified by stage, a trend toward a better disease-free and cancer-related survival was identified in stage III patients undergoing LR. CONCLUSIONS: Laparoscopic colonic resection is a safe procedure in terms of postoperative outcome and long-term survival. Multivariate analysis showed that laparoscopy is a positive prognostic factor for disease-free and cancer-related survival. The current data agrees with the data for the only randomized study reported so far. Both suggest a better outcome for node-positive patients treated by laparoscopy.

[Indications and results of radical treatment of gallbladder carcinoma]. / Indicazioni e risultati del trattamento radicale del carcinoma della colecisti.

Extended cholecystectomy is the only chance of a cure for patients with locally advanced cancer of the gallbladder. The aim of the study was to evaluate the short- and long-term results of surgical treatment and to define the prognostic factors associated with better survival. We conducted a retrospective study in 81 patients with gallbladder cancer admitted to our surgical department from 1985 to 1999. Radical surgery was performed on 39 patients. The type of surgical treatment was based on the TNM stage of the disease: all but stage I patients underwent extended cholecystectomy (resection of segment IVa-V, N1-2 lymph-node dissection). The mortality and morbidity rates were 5.1% and 28.2%, respectively. In the patients undergoing curative resection, the 5-year survival was 31.5% (75% in T1 patients, 57.1% in T2, 25.9% in T3 and 0% in T4. Long-term survival of patients with T1-2 tumours was significantly better than that of T3 (P = 0.02) or T4 patients (P = 0.0003); 53.6% of N0 patients were still alive at 5 years as against only 14.5% of N+ patients (P = 0.06). Depth of infiltration is an important prognostic factor. The presence of lymph-node metastases should not be a contraindication to surgery since long-term survival is possible.

[The therapeutic strategy in calculosis of the main biliary tract]. / La strategia terapeutica della calcolosi della VBP.

With the advent of laparoscopic techniques and other nonoperative techniques, the management of patients with common bile duct (CBD) stones became more complex. With low, medium or high preoperative suspicion of CBD stones, three factors influence the correct management: the degree of endoscopic, radiologic and laparoscopic expertise; the severity of symptoms; the presence or absence of the gallbladder. In patients with a low probability of having CBD stones routine ERCP pre-LC appears inappropriate. The management of patients with medium probability of CBD stones depends on the ability of the laparoscopist to remove CBD stones. A single laparoscopic procedure for cholelithiasis and CBD stones would be the best approach in the majority of patients. ERCP should be considered the procedure of choice in patients with severe gallstones pancreatitis, acute cholangitis and in those with a high probability of having CBS stones.

[Complications of the surgical treatment of hemorrhoids and its therapy]. / Le complicanze della terapia chirurgica delle emorroidi ed il loro trattamento.

Hemorrhoidal disease is a common problem in a proctological ambulatory. Surgery is the best therapy for fourth degree hemorrhoids and the complication rate is 10-20%: postoperative urinary retention etiology is unknown but it may be caused by dysfunction of bladder muscles in response to pain and by an excessive perioperative somministration of fluids; delayed hemorrhage (i.e., 7-10 days postoperative) needs an inpatient care and the treatment ranges from bedside and packing to hemorrhoid pedicle suture ligation in the operating room. Anal stenosis is most commonly a result of a prior improper hemorrhoidectomy: it may be mild, moderate or severe; V-Y and C-anoplasty are the best therapy, also for ectropion. Rubber band Ligation and Sclerotherapy are the most common treatment of internal hemorrhoids: external hemorrhoid trombosis and delayed hemorrage are frequent complications.