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.

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.

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.

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.

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.

Low rates of loco-regional recurrence following extended lymph node dissection for gastric cancer.

AIM: The study by MacDonald et al. [Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 2001;345:725-30] has reported low loco-regional recurrence rates (19%) after gastric cancer resection and adjuvant radiotherapy. However, the lymph node dissection was often "inadequate". The aim of this retrospective study is to analyse if an extended lymph node dissection (D2) without adjuvant radiotherapy may achieve comparable loco-regional recurrence rates. METHODS: A prospective database of 200 patients who underwent a curative resection for gastric carcinoma from January 2000 to December 2006 was analysed. D2 lymph node dissection was standard. Recurrences were categorized as loco-regional, peritoneal, or distant. No patients received neoadjuvant or adjuvant radiotherapy. RESULTS: The in-hospital mortality rate was 1% (2 patients). The mean number of dissected lymph nodes was 25.9. Overall and disease-free survival at 5years were 60.7% and 61.2% respectively. During the follow-up, 60 patients (30%) have recurred at 76 sites: 38 (50%) distant metastases, 25 (32.9%) peritoneal metastases, and 13 (17.1%) loco-regional recurrences. The loco-regional recurrence was isolated in 6 patients and associated with peritoneal or distant metastases in 7 patients. The mean time to the first recurrence was 18.9 (95% confidence interval: 15.0-21.9) months. CONCLUSIONS: Extended lymph node dissection is safe and warrants low loco-regional recurrence rates.

Local surgical resection of hilar cholangiocarcinoma: is there still a place?

In recent decades, surgical treatment of hilar cholangiocarcinoma has moved toward liver surgery in association with biliary resection in order to increase radicality and to achieve better survival. Results of local resection compared with hepatectomy associated with bile duct resection and its actual indications have to be clarified. A systematic review of relevant studies published before December 2007 was performed. Original published studies comparing the results of isolated local excision with those of hepatectomy associated with bile duct resection were identified and the reported results were synthesized. The pathologic data suggest that isolated bile duct resection cannot be adequate: required wide surgical margins; neoplastic extension along perineural sheaths; Segment 1 neoplastic invasion. Considering postoperative outcomes, in the 1990s, local resection had significantly lower mortality rates than liver resection. In recent years, the short-term results of liver surgery have improved significantly, while mortality rates have decreased. The R0 resection rate is significantly higher after associated liver resection. Comparison of survival results between local resection and associated liver surgery is difficult because, in the majority of series, the treatment was planned according to tumor extension. Better long-term outcomes have been reported after liver resection than after isolated bile duct resection, even for Bismuth-Corlette type I-II cholangiocarcinoma. Long-term survivors after local resection have been reported in a few selected patients with Bismuth-Corlette type I Tis-T1 or papillary neoplasm.

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.

Neoadjuvant chemotherapy and resection for initially irresectable colorectal liver metastases.

BACKGROUND: Hepatic surgery is the treatment of choice for resectable colorectal liver metastases. Neoadjuvant chemotherapy can downstage the tumour and enable surgery in up to 38 per cent of patients whose tumours were initially considered irresectable. METHODS: This prospective study included 150 patients who underwent hepatic resection over a 4-year period. One hundred and sixteen patients had resection without neoadjuvant chemotherapy (group 1) and 34 had chemotherapy before liver surgery (group 2). Perioperative features, survival and pattern of recurrence were compared. RESULTS: Median follow-up was 35.1 months. The in-hospital mortality rate was zero. Three-year overall survival in the two groups was comparable (P = 0.232). The 3-year disease-free survival rate was 21 per cent in the neoadjuvant group compared with 50.5 per cent in the immediate resection group (P < 0.001). Recurrence rates were 94 per cent (32 of 34) in group 1 and 66.4 per cent in group 2 (P = 0.001); extrahepatic recurrence, alone or associated with recurrence in the liver, was significantly more common in group 2 than in group 1 (78 versus 55 per cent; P = 0.016). Multivariate analysis revealed that resection of the recurrence was the most important independent prognostic factor for improved disease-free survival (relative risk 0.2; P < 0.001). Patients in group 2 had reduced disease-free survival (RR 1.8; P = 0.012). CONCLUSION: The recurrence rate among patients who had neoadjuvant chemotherapy and surgery for initially irresectable liver metastases was extremely high. Re-resection should be attempted whenever feasible.

Randomized clinical trial of liver resection with and without hepatic pedicle clamping.

BACKGROUND: The purpose of this study was to compare the perioperative outcome of liver resection with and without intermittent hepatic pedicle clamping. METHODS: Between June 2002 and June 2004, 126 consecutive patients with resectable liver tumours were randomized to undergo resection with (63 patients) or without (63 patients) intermittent hepatic pedicle clamping. RESULTS: The transection time was significantly higher in the group without hepatic pedicle clamping. The blood loss per cm(2) was similar in the two groups: 2.7 ml/cm(2) in the group with versus 3.2 ml/cm(2) in group without hepatic pedicle clamping (P = 0.425). In the subset of patients with an abnormal liver, there were no differences in blood loss per transection surface: 3.1 ml/cm(2) in the group with versus 2.9 ml/cm(2) in the group without clamping (P = 0.829). The rate of blood transfusions was not higher in the non-clamping group. No differences were observed in the postoperative liver enzyme serum levels, the in-hospital mortality (one patient in each group) or the number of complications. CONCLUSION: This study showed clearly that liver resection without hepatic pedicle clamping is safe, even in patients with a diseased liver.

Diagnostic accuracy of portal-phase CT and MRI with mangafodipir trisodium in detecting liver metastases from colorectal carcinoma.

AIM: To compare the diagnostic accuracy of single section spiral computed tomography (CT) and magnetic resonance imaging (MRI) with tissue-specific contrast agent mangafodipir trisodium (MnDPDP) in the detection of colorectal liver metastases. MATERIAL AND METHODS: One hundred and twenty-five consecutive patients undergoing surgery for primary and/or metastatic disease were evaluated using CT (5 mm collimation and reconstruction interval, pitch 2), two-dimensional fast spoiled gradient echo (2D FSPGR) T1 and single shot fast-spin echo (SSFSE) T2 weighted breath-hold MRI sequences, performed before and after intravenous administration of MnDPDP. The reference standards were intraoperative ultrasound and histology. RESULTS: The per-patient accuracy of CT was 72.8 versus 78.4% for unenhanced MRI (p = 0.071) and 82.4% for MnDPDP-enhanced MRI (p = 0.005). MnDPDP-enhanced MRI appeared to be more accurate than unenhanced MRI but this was not significant (p = 0.059). The sensitivity of CT was 48.4% versus 58.1% for unenhanced MRI (p = 0.083) and 66.1% for MnDPDP-enhanced MRI (p = 0.004). The difference in specificity between procedures was not significant. The per-lesion sensitivity was 71.7, 74.9 and 82.7% for CT, unenhanced MRI, and MnDPDP-enhanced MRI, respectively; the positive predictive value of the procedures was respectively 84.0, 96.0 and 95.8%. MnDPDP-enhanced MRI provided a high level diagnostic confidence in 92.5% of the cases versus 82.5% for both unenhanced MRI and CT. The kappa value for inter-observer variability was >0.75 for all procedures. CONCLUSIONS: The diagnostic accuracy and sensitivity of MnDPDP-enhanced MRI is significantly higher than single section spiral CT in the detection of colorectal cancer liver metastases; no significant difference in diagnostic accuracy was observed between unenhanced MRI and MnDPDP-enhanced MRI.

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.

[Parenchyma sparing: evolution of the resective surgical approach of hepatic metastasis from the colorectum]. / Il risparmio di parenchima: evoluzione della strategia chirurgica resettiva delle metastasi epatiche colorettali.

Liver surgery for colorectal metastasis has moved toward a parenchymal sparing strategy in order to reduce postoperative liver failure, to resect an higher number of metastases and to allow a future re-resection. Patients undergone hepatectomy in our Department before and after 1999 were retrospectively compared. In the recent years surgery became more aggressive: a higher number of patients with multiple and bilateral lesions were treated. Short-term results improved in the recent series. After 1999, the rate of wedge resections was significantly increased with the same oncological radicality and with improved long-term results. Moreover, parenchymal sparing strategy allowed a higher re-resection rate in patients with liver recurrence.

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.

Prospective randomized study of steroids in the prevention of ischaemic injury during hepatic resection with pedicle clamping.

BACKGROUND: The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function. Perioperative steroid administration has been advocated to reduce liver damage. The aim of this prospective, randomized study was to determine whether steroid administration can reduce liver injury and improve short-term outcome. METHODS: Fifty-three patients undergoing liver resection were randomized to a steroid group (group 1) or to a control group (group 2); patients in group 1 received methylprednisolone 30 mg/kg 30 min before liver resection whereas those in group 2 did not. Serum levels of interleukin (IL) 6, total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and prothrombin time (PT) were measured. Length of stay, and type and number of complications were recorded. RESULTS: Serum IL-6 levels were significantly lower in the steroid group than in the control group 24 h after surgery. Steroid administration significantly modified AST, ALT and PT levels only in patients with chronic liver disease. Overall and lung-related morbidity were not significantly different between the two groups. CONCLUSIONS: Steroid administration suppresses serum IL-6 levels, but has no effect on short-term outcome.

Repeat hepatectomy for colorectal liver metastases: A worthwhile operation?

BACKGROUND AND OBJECTIVES: After curative resection of hepatic colorectal metastases, 10-20% of patients experience a resectable hepatic recurrence. We wanted to assess the expected risk-to-benefit ratio in comparison to first hepatectomy and to determine the prognostic factors associated with survival. METHODS: Twenty-nine patients from a group of 152 patients resected for colorectal liver metastases underwent 32 repeat hepatectomies. RESULTS: In-hospital mortality was 3.5% (1/29 patients); the morbidity after repeat hepatectomy was lower than that after first hepatic resection. Combined extrahepatic surgery was performed on 34.5% of repeat hepatectomies vs. 6.9% of first hepatectomies (P = 0.01). Overall actuarial 3-year survival was 35.1%: four patients have survived more than 3 years and one survived for more than 5 years. The number of hepatic metastases and the carcinoembryonic antigen (CEA) serum levels were significant prognostic factors on univariate analysis. The synchronous resection of hepatic and extrahepatic disease was not associated with a lower survival rate when compared with that of patients without extrahepatic localization: three patients of the former group are alive and disease-free at more than 2 years. CONCLUSIONS: Repeat hepatic resection can provide long-term survival rates similar to those of first liver resection, with comparable mortality and morbidity. The presence of resectable extrahepatic disease must not be an absolute contraindication to synchronous hepatectomy because long-term survival is possible.