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.

Enhanced recovery pathways in colorectal surgery: a consensus paper by the Associazione Chirurghi Ospedalieri Italiani (ACOI) and the PeriOperative Italian Society (POIS).

Enhanced Recovery After Surgery (ERAS) pathway is a multi-disciplinary, patient-centered protocol relying on the implementation of the best evidence-based perioperative practice. In the field of colorectal surgery, the application of ERAS programs is associated with up to 50% reduction of morbidity rates and up to 2.5 days reduction of postoperative hospital stay. However, widespread adoption of ERAS pathways is still yet to come, mainly because of the lack of proper information and communication. Purpose of this paper is to support the diffusion of ERAS pathways through a critical review of the existing evidence by members of the two national societies dealing with ERAS pathways in Italy, the PeriOperative Italian Society (POIS) and the Associazione Italiana Chirurghi Ospedalieri (ACOI), showing the results of a consensus development conference held at Matera, Italy, during the national ACOI Congress on June 10, 2019.

Enhanced recovery after surgery efficacy in an older patients and high-risk population affected by colorectal cancer: a more than 1000 patients experience.

AIM: Enhanced recovery after surgery programs aims to standardize care, improving colorectal surgery outcomes. Older patients are a challenge population for these programs. The aim of this manuscript is to explore the effect of application Enhanced recovery after surgery protocol among older patients and high-risk patients undergone colorectal surgery for cancer. METHOD: Since January 2005, until September 2016, 1189 consecutive patients underwent elective Colorectal Surgery and treated according to our Enhanced recovery after surgery protocol. Patients are divided in three groups according to age: Group1 under 69 y-o (control group), Group2 70 to 79 y-o and Group3 over 80 y-o. Primary end point was Time to Readiness to Discharge. RESULTS: Median Time to Readiness to Discharge was 4 days (3-30) in Group 1, 5 (3-47) in Group 2 and 5 (3-19) in Group 3. Length of stay in Group 1 had a median length of 6 days (3-58), in Group 2 of 8 days (3-70) and in Group 3 of 8 days (3-53). CONCLUSIONS: Once more Enhanced recovery after surgery program has showed its efficacy in colorectal surgery field. Moreover, our experience has underlined the need to concentrate efforts mainly on older and high-risk patients.

Laparoscopic adhesiolysis: consensus conference guidelines.

AIM: Laparoscopic adhesiolysis has been demonstrated to be technically feasible in small bowel obstruction and carries advantages in terms of post-surgical course. The increasing dissemination of laparoscopic surgery in the emergency setting and the lack of concrete evidence in the literature have called for a consensus conference to draw recommendations for clinical practice. METHODS: A literature search was used to outline the evidence, and a consensus conference was held between experts in the field. A survey of international experts added expertise to the debate. A public jury of surgeons discussed and validated the statements, and the entire process was reviewed by three external experts. RESULTS: Recommendations concern the diagnostic evaluation, the timing of the operation, the selection of patients, the induction of the pneumoperitoneum, the removal of the cause of obstructions, the criteria for conversion, the use of adhesion-preventing agents, the need for high-technology dissection instruments and behaviour in the case of misdiagnosed hernia or the need for bowel resection. CONCLUSION: Evidence of this kind of surgery is scanty because of the absence of randomized controlled trials. Nevertheless laparoscopic skills in emergency are widespread. The recommendations given with the consensus process might be a useful tool in the hands of surgeons.

[A single effective way to reduce post-thyroidectomy discomfort: a clinical trial]. / Un metodo semplice ed efficace per ridure il discomfort dopo tiroidectomia: un trial clinico.

AIM: Nausea, with or without vomiting (postoperative nausea and vomiting, PONV), occurs up to 60-76% after thyroidectomy and other head and neck surgeries. Due to the fact that patients typically have only mild-to-moderate pain after thyroid or parathyroid surgery, PONV might be the main source of discomfort, and it may be perceived as the most unpleasant aspect of postoperative recovery. This study aims to assess the effects of a preoperative single dose of 8 mg dexamethasone on the nausea, vomiting, pain, and subjective vocal function after thyroidectomy in patients undergoing surgery for benign disease. METHODS: Seventy patients operated on for thyroidectomy were randomized in two groups: Group A, 8 mg/2 mL of dexamethasone administered in 100 mL of physiologic saline given intravenously (i.v.) 20 minutes before the induction of anesthesia; group B, 2 mL NaCl 0.9% in 100 mL of physiologic saline. Postoperative therapy has been standardized. PONV have been evaluated with a scale of 4, degrees (0-3), pain by a Visual Analog Scale (0-100) and subjective vocal function by a Visual Analog Scale (0-100) at 8, 24, 32 and 48 hours after surgery. RESULTS: The severity of nausea was less in patients of group A (P=0.0001); Dexamethasone patients reported significantly less pain (P=0.008); no differences were noted about the subjective voice analysis (P=0.693). No steroid-related complications occurred. CONCLUSION: Dexamethasone 8 mg i.v. is a safe and effective method to reduce PONV and pain after thyroid resection and we advise its routine use.

[Feasibility and effectiveness of laparoscopic right colectomy with extracorporeal anastomosis]. / Emicolectomia destra laparoscopia con anastomosi intracorporea: fattibilità ed efficacia.

AIM: Despite the laparoscopic right hemicolectomy has been validated by many randomized prospective trials, clear evidences on the validity of the totally mini-invasive technique, namely, through intracorporeal anastomosis, are still lacking. The aim of this study was the assessment of short-term outcome within three months from laparoscopic right colectomy with intra- or extra-corporeal anastomosis. METHODS: With no exclusion, all patients undergoing laparoscopic right hemicolectomy at our institution have been enrolled in this study. Group A included patients undergoing laparoscopic right hemicolectomy with extracorporeal anastomosis (LAC) and Group B, included patients undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis (TLC). Patients' data, surgery details, results of postoperative period and histological tests have been prospectively recorded in a database and analysed. RESULTS: Between December 2006 and December 2008, 45 patients underwent right hemicolectomy, 21 with extracorporeal anastomosis and 24 had intracorporeal ones. As to patients' characteristics and histopathological results there are no difference between the groups. Anastomotic dehiscence occurred one in group A and one in group B (P>0.05). Both patients underwent reoperation. We recorded 6 postoperative ileus with vomiting in the LAC group and only 1 in the TLC group (P<0.05). The incidence of Non-Surgical Site Complications (NSSC) was of 4.54% in LAC group and 8.33% in TLC group (P>0.05). Hospitalization was of 5 days for both groups. CONCLUSION: In conclusion, we believe that this technique is feasible in terms of safety; it doesn't significatively affect the length of surgical procedure and guarantees maintenance of oncological radicality standards of reference. Besides it significatively improves quality of the post-operative period.

[A new effective method to reduce pain after laparoscopic cholecystectomy]. / Un nuovo efficace sistema per ridurre il dolore dopo videolaparocolecistectomia.

BACKGROUND: The primary aim of this randomized controlled prospective study (www.clinicaltrials.gov NCT00599144) was assessing effectiveness on pain control after videolaparoscopic cholecystectomy (VLC) of 0.5% Bupivacaine-soaked sheet of regenerated oxidized cellulose positioned in the gallbladder bed. PATIENTS AND METHODS: We randomized in three equal groups 45 patients that underwent elective videolaparoscopic cholecystectomy: group A - Bupivacaine-soaked sheet of regenerated oxidized cellulose positioned in the gallbladder bed; group B - Bupivacaine infiltrated in the muscular fasciae of the trocars' seat; group C - control group, not using local anesthetic. Six and 24 hours after the intervention we recorded the type of the pain and its intensity, using a visual analog scale (VAS). RESULTS: We observed no statistically significant difference in pain intensity. Considering the type of pain, 55,56% of patients referred visceral pain, 62,22% parietal pain and 44,44% shoulder pain. Group A shows, at both endpoints, a statistically significant reduction (p < 0.05) of visceral and shoulder pain versus other groups. Moreover, the use of a local anesthetic significantly reduces the use of post-operative pain drugs, both for group A and B. CONCLUSION: A Bupivacaine-soaked sheet of regenerated oxidized cellulose positioned in the gallbladder bed post-VLC is safe and not economically demanding, and can give advantages in increasing post-operative comfort.

Modular branched neurotensin peptides for tumor target tracing and receptor-mediated therapy: a proof-of-concept.

The aim of this study was to demonstrate that oligo-branched peptides can be effective either for spotlighting tumor cells that overexpress peptide receptors, or for killing them, simply by exchanging the functional moiety coupled to the conserved receptor-targeting core. Tetra-branched peptides containing neurotensin (NT) sequence are described here as selective targeting agents for human colon, pancreas and prostate cancer. Fluorophore-conjugated peptides were used to measure tumor versus healthy tissue binding in human surgical samples, resulting in validation of neurotensin receptors as highly promising tumor-biomarkers. Drug-armed branched peptides were synthesized with different conjugation methods, resulting in uncleavable adducts or drug-releasing molecules. Cytotoxicity on human cell lines from colon (HT-29), pancreas (PANC-1) or prostate (PC-3) carcinoma indicated branched NT conjugated with MTX and 5-FdU as the most active agents on PANC-1 (EC(50) 4.4e-007 M) and HT-29 (1.1e-007 M), respectively. Tetra-branched NT armed with 5-FdU was used for in vivo experiments in HT-29-xenografted mice and produced a 50% reduction in tumor growth with respect to animals treated with the free drug. An unrelated branched peptide carrying the same drug was completely ineffective. In vitro and in vivo results indicated that branched peptides are valuable tools for tumor selective targeting.

[The development of a fast track surgery program after laparoscopic colonic surgery in a General Surgery Unit]. / Lo sviluppo di un Protocollo di Fast Track Surgery dopo colectomia laparoscopica in una Unità di Chirurgia Generale.

AIM: The aim of the "Fast-Track Surgery" program is to decrease the perioperative stress response to surgical trauma and thus to decrease the complication rates after elective surgery. Critics of the "Fast-Track"(FT) rehabilitation may argue that all reports of successful programs came from major specialised hospital units and that implementation in smaller or less specialised units may be difficult, if not impossible. METHODS: We retrospectively studied 101 patients that, from November 2004 to October 2007, underwent laparoscopic colorectal surgery in our institute. A detailed "Fast-Track Surgery" protocol was prepared and given to patients, physicians and nurses, with the aim to create a standard treatment. Data about demographics, ASA score, preoperative complicating diseases, diagnosis, type of surgery and postoperative clinical data were analyzed. Univariate analysis of the relationship among all factors (patient characteristics, intervention characteristics, protocol compliance and presence of complications) described here and length of hospital stay was performed. RESULTS: We compared our results to those of major trials previously published and observed no substantial differences in morbidity, mortality and length of postoperative hospital stay between the two. Univariate analysis showed that compliance to the elements of the FT protocol influences the length of postoperative period more significantly than the patient characteristics or surgical procedure. CONCLUSION: Based on six comparative single-centre studies, the FT program was found to reduce length of hospital stay and was deemed safe for major abdominal surgeries. The present study shows that enhanced recovery or FT program can also be implemented safely in a General Surgery Unit.

[Laparoscopic approach in acute bowel obstruction due to ileal endometriosis: case report]. / Occlusione intestinale acuta da endometriosi ileale trattata in laparoscopia. Case report.

Endometriosis affects 10-20% of fertile women, and in 3-37% of them it extends to the bowel. Its location, in the ileal tract of the bowel, usually the end-part, is only the 7%; and the occurrence of intestinal obstruction is no more than 0.15% of patients affected by endometriosis. We present a case of acute bowel obstruction due to ileal endometriosis in a 39 years woman, diagnosed and treated by laparoscopic approach.

Incisional hernia: repair retrospective comparison of laparoscopic and open techniques.

PURPOSE: A retrospective clinical trial was conducted to compare laparoscopic incisional hernia repair (LIHR) and open traditional repair (OR). Demographics, perioperative data, results, and follow-up data were examined to determine whether there was any difference in outcome, recurrences, and costs. METHODS: From January 2000 to June 2002, 42 consecutive, unselected patients who successfully underwent LIHR were matched with 49 consecutive, unselected patients who received OR during the same period. The operating room database, clinical files, and outpatient sheets were examined. Patient demographics, results, follow-up data, and costs were compared between the two groups. RESULTS: Demographic characteristics, obesity, ASA status, type of hernia, concomitant surgery, urgencies, and incidences of previous repair were well matched between the two groups. Hernia defect was significantly larger in the OR group (122 cm2) than in the LIHR group (83 cm2; p = 0.0006). The operative times and the overall complications rates were similar, but wound infections were more common in the OR group (12% vs 0%; p = 0.04). The analgesic requirement was smaller (mean ketorolac injections, 2 vs 5; p < 0.0001; additional opiates, 0% vs 24%; p = 0.0006) and the hospital stay was shorter (5 vs 8 days; p < 0.0001) in the LIHR group. No recurrences were noted in the LIHR group, but there were three recurrences (6%) in the OR group ( p = 0.30, not statistically significant). The cost of the prosthesis was higher for laparoscopic procedure, although the reduction in the hospital stay largely balanced the overall cost ( p = 0.017). CONCLUSIONS: In this study, LIHR appeared to be as safe as OR. Despite the fact that LIHR raised the prosthesis-related costs, the findings showed that LIHR has clinical (less wound complications, shorter hospital stay, reduced pain) and financial advantages over OR.

Weekly gemcitabine plus Epirubicin as effective chemotherapy for advanced pancreatic cancer: a multicenter phase II study.

The current role of chemotherapy in pancreatic carcinoma is limited, and progress in the treatment of this disease represents a significant challenge to medical oncology. The most promising drug under study is gemcitabine, a relatively new antimetabolite that represents an attractive candidate for combination chemotherapy because of its excellent side-effect profile and the absence of overlapping toxicities with other chemotherapeutic agents. Combined administration of gemcitabine and anthracyclines could result in the induction of DNA breaks that are not easily repaired by the cell's machinery, thus enhancing the apoptotic signals triggered by these lesions. Forty-four patients with locally advanced and/or metastatic pancreatic adenocarcinoma were enrolled in this multicenter study. Patients received Epirubicin 20 mg m(-2) for 3 weeks followed by 1 week of rest (1 cycle) and gemcitabine 1000 mg m(-2) after Epirubicin on the same day. All were assessable for toxicity and response, 11 patients responded to treatment with one complete response and 10 partial responses, for an overall response rate of 25%. Median survival was 10.9 months (range, 2-26 months). Therapy was well tolerated, with a low incidence of haematologic grade >2 toxicity. A total of 12 of 27 (44.4%) eligible patients attained a clinical benefit response. Our findings suggest that the gemcitabine-epirubicin schedule is active and well tolerated in patients with advanced pancreatic cancer.

Results of leucovorin and doxifluridine oral regimen in the treatment of metastatic colorectal cancer.

We conducted a multicentric phase II study on advanced colorectal cancer to determine the efficacy and toxicity of oral treatment with leucovorin (LV) plus doxifluridine (5'DFUR), a novel fluoropyrimidine derivative with proven antitumor activity in different experimental models. Thirty-six outpatients with measurable disease entered the trial and received orally LV 20 mg in the morning and in the afternoon, and 2 h later 5'-DFUR 500 mg/m2 every 2 days for 3 months. Thirty-four evaluable patients underwent a total of 408 weeks of treatment. The response rate was 35%, with two complete remissions and 10 partial responses. The median survival of patients who responded to treatment (responders) was 17.1 months (range 4-32), which was significantly longer (p<0.001) than the 6.5 months (range 2-11) of the patients who did not respond (non-responders). Therefore, after 4-8 weeks of treatment, 14 patients (41%) had an improvement in their performance status and/or stabilization of pain. General toxicity was usually mild, myelo and gastrointestinal toxicity were moderate, and there was no evidence of relevant neurological toxicity. These results show that a home therapy with oral LV-5'DFUR is a safe and effective treatment regimen for metastatic colorectal carcinoma.

[Splenic injuries: recent acquisitions concerning the treatment]. / Traumi splenici: recenti acquisizioni in tema di trattamento.

The Authors briefly review spleen functions and the consequences of splenectomy particularly for what the immune function is concerned. Data concerning postoperative infections following splenectomy for staging laparotomy in 92 patients with lymphoma are analysed. Data concerning immunological function of 17 pts. who underwent splenectomy in the last 5 yrs. compared to 17 normal controls, homogeneous for sex and age, are reported. Plasma IgM decrease in 3 cases, CMI anergic status in 3 cases and CD4+/CD8+ lymphocyte ratio increase in 8 cases were observed. This article also reviews surgical techniques and recent knowledge in relation to the best treatment for splenic traumas, emphasizing advantages and disadvantages of conservative treatment. The Authors conclude presenting their personal series of 42 pts. affected with traumatic lesions of the spleen treated in the last 10 yrs., also illustrating a treatment flow-chart.