Carlo Vallicelli

Evaluation of extensive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced epithelial ovarian cancer.

Objective Although standard treatment for advanced epithelial ovarian cancer (EOC) consists of surgical debulking and intravenous platinum- and taxane-based chemotherapy, favorable oncological outcomes have been recently reported with the use of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The aim of the study was to analyze feasibility and results of CRS and HIPEC in patients with advanced EOC. Materials/Methods This is an open, prospective phase 2 study including patients with primary or recurrent peritoneal carcinomatosis due to EOC. Thirty-nine patients with a mean (SD) age of 57.3 (9.7) years (range, 34–74 years) were included between September 2005 and December 2009. Thirty patients (77%) had recurrent EOC and 9 (23%) had primary EOC. Results For HIPEC, cisplatin and paclitaxel were used for 11 patients (28%), cisplatin and doxorubicin for 26 patients (66%), paclitaxel and doxorubicin for 1 patient (3%), and doxorubicin alone for 1 patient (3%). The median intra-abdominal outflow temperature was 41.5°C. The mean peritoneal cancer index (PCI) was 11.1 (range, 1–28); and according to the intraoperative tumor extent, the tumor volume was classified as low (PCI <15) or high (PCI ≥15) in 27 patients (69%) and 12 patients (31%), respectively. Microscopically complete cytoreduction was achieved for 35 patients (90%), macroscopic cytoreduction was achieved for 3 patients (7%), and a gross tumor debulking was performed for 1 patient (3%). Mean hospital stay was 23.8 days. Postoperative complications occurred in 7 patients (18%), and reoperations in 3 patients (8%). There was one postoperative death. Recurrence was seen in 23 patients (59%) with a mean recurrence time of 14.4 months (range, 1–49 months). Conclusions Hyperthermic intraperitoneal chemotherapy after extensive CRS for advanced EOC is feasible with acceptable morbidity and mortality. Complete cytoreduction may improve survival in highly selected patients. Additional follow-up and further studies are needed to determine the effects of HIPEC on survival.

Small bowel emergency surgery: literature's review

Emergency surgery of the small bowel represents a challenge for the surgeon, in the third millennium as well. There is a wide number of pathologies which involve the small bowel. The present review, by analyzing the recent and past literature, resumes the more commons. The aim of the present review is to provide the main indications to face the principal pathologies an emergency surgeon has to face with during his daily activity.

Mast Cells Positive to Tryptase and c-Kit Receptor Expressing Cells Correlates with Angiogenesis in Gastric Cancer Patients Surgically Treated

Background. Angiogenesis is a complex process involved in both growth and progression of several human and animal tumours. Tryptase is a serin protease stored in mast cells granules, which plays a role in tumour angiogenesis. Mast cells (MCs) can release tryptase following c-Kit receptor (c-KitR) activation. Method. In a series of 25 gastric cancer patients with stage T3N2-3M0 (by AJCC for Gastric Cancer 7th Edition), immunohistochemistry and image analysis methods were employed to evaluate in the tumour tissue the correlation between the number of mast cells positive to tryptase (MCPT), c-KitR expressing cells (c-KitR-EC), and microvascular density (MVD). Results. Data demonstrated a positive correlation between MCPT, c-KitR-EC, and MVD to each other. In tumour tissue the mean number of MCPT was 15, the mean number of c-KitR-EC was 20, and the mean number of MVD was 20. The Pearson test correlating MCPT and MVD, c-KitR-EC and MVD was significantly (r = 0.64, P = 0.001; r = 0.66, P = 0.041, resp.). Conclusion. In this pilot study, we suggest that MCPT and c-KitR-EC play a role in gastric cancer angiogenesis, so we think that several c-KitR or tryptase inhibitors such as gabexate mesilate and nafamostat mesilate might be evaluated in clinical trials as a new antiangiogenetic approach.

The SIC-GIRCG 2013 Consensus Conference on Gastric Cancer

The topic chosen by the Board of the Italian Society of Surgery for the 2013 annual Consensus Conference was gastric cancer. With this purpose, under the direction of 2 chairmen, 36 experts nominated by the Regional Societies of Surgery and by the Italian Research Group for Gastric Cancer (GIRCG) participated in an experts consensus exercise, preceded by a questionnaire and mainly held by telematic vote, in accordance with the rules of the Delphi method. The results of this Consensus Conference, presented to the 115th National Congress of the Italian Society of Surgery, and approved in plenary session, are reported in the present paper.

Ureteral Stenting in Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy as a Routine Procedure: Evidence and Necessity

Introduction: There is a need for more exhaustive data concerning the use of prophylactic ureteral stenting for extended debulking and cytoreductive procedures in the literature. Material and Methods: A retrospective analysis of the CARPEPACEM study protocol database was performed. The trial protocol schedules the positioning of bilateral ureteral stents before cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (HIPEC). Results: Fifty-one operated patients: 31 (59.6%) with peritoneal dissemination from ovarian cancer, 8 (15.3%) from colorectal cancer, 4 (7.9%) from pseudomyxoma peritonei, 3 (5.7%) from gastric cancer, 2 (3.8%) from peritoneal mesothelioma, 1 (1.9%) from appendiceal cancer, 1 (1.9%) from endometrial cancer, and 1 (1.9%) from leiomyosarcoma. Mean and median peritoneal cancer index: 11 and 10 (range: 0–28). CC-score: CC-0 in 45 (86.5%) patients, CC-1 in 5 (9.6%) and CC-2 in 1 (1.9%). HIPEC was performed with platinum + taxol in 22 patients (42.3%), platinum + adriablastin in 10 (19.2%), mitomycin in 9 (17.3%), platinum + mitomycin in 7 (13.4%), platinum + doxorubicin in 2 (3.8%), and taxol + adriablastin in 1 (1.9%). Two major ureteral complications were observed (3.9%). Discussion: Prophylactic ureteral stenting could reduce the risk of postoperative ureteral complications without an increase in stent placement-related complications; however, a randomized clinical trial is needed.

The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis

BackgroundThe HARMONIC SCALPEL (H) is an advanced ultrasonic cutting and coagulating surgical device with important clinical advantages, such as: reduced ligature demand; greater precision due to minimal lateral thermal tissue damage; minimal smoke production; absence of electric corrents running through the patient. However, there are no prospective RCTs demonstrating the advantages of H compared to the conventional monopolar diathermy (MD) during laparoscopic cholecystectomy (LC) in cases of acute cholecystitis (AC).MethodsThis study was a prospective, single-center, randomized trial (Trial Registration Number: NCT00746850) designed to investigate whether the use of H can reduce the incidence of intra-operative conversion during LC in cases of AC, compared to the use of MD. Patients were divided into two groups: both groups underwent early LC, within 72 hours of diagnosis, using H and MD respectively (H = experimental/study group, MD = control group). The study was designed and conducted in accordance with the regulations of Good Clinical Practice.Results42 patients were randomly assigned the use of H (21 patients) or MD (21 patients) during LC. The two groups were comparable in terms of basic patient characteristics. Mean operating time in the H group was 101.3 minutes compared to 106.4 minutes in the control group (p=ns); overall blood loss was significantly lower in the H group. Conversion rate was 4.7% for the H group, which was significantly lower than the 33% conversion rate for the control group (p<0.05). Post-operative morbidity rates differed slightly: 19% and 23% in the H and control groups, respectively (p=ns). Average post-operative hospitalization lasted 5.2 days in the H group compared to 5.4 days in the control group (p=ns).ConclusionsThe use of H appears to correlate with reduced rates of laparoscopic-open conversion. Given this evidence, H may be more suitable than MD for technically demanding cases of AC.

T.E.A. Study: three-day ertapenem versus three-day Ampicillin-Sulbactam

BackgroundIntra-abdominal infections are one of the most common infections encountered by a general surgeon. However, despite this prevalence, standardized guidelines outlining the proper use of antibiotic therapy are poorly defined due to a lack of clinical trials investigating the ideal duration of antibiotic treatment. The aim of this study is to compare the efficacy and safety of a three-day treatment regimen of Ampicillin-Sulbactam to that of a three-day regimen of Ertapenem in patients with localized peritonitis ranging from mild to moderate severity.MethodsThis study is a prospective, multi-center, randomized investigation performed in the Department of General, Emergency, and Transplant Surgery of St. Orsola-Malpighi University Hospital in Bologna, Italy. Discrete data were analyzed using the Chi-squared and Fisher exact tests. Differences between the two study groups were considered statistically significant for p-values less than 0.05.Results71 patients were treated with Ertapenem and 71 patients were treated with Ampicillin-Sulbactam. The two groups were comparable in terms of age and gender as well as the site of abdominal infection. Post-operative infection was identified in 12 patients: 10 with wound infections and 2 with intra-abdominal infections. In the Ertapenem group, 69 of the 71 patients (97%) were treated successfully, while the therapy failed in 2 cases (3%). Therapy failures were more frequent in the Unasyn group, amounting to 10 of 71 cases (p = 0.03).ConclusionAccording to these preliminary findings, the authors conclude that a three-day Ertapenem treatment regimen is the most effective antibiotic therapy for patients with localized intra-abdominal infections ranging from mild to moderate severity.Trial registrationTrial registration: ClinicalTrials.gov: NCT00630513

Prepouch Ileitis After Ileal Pouch-anal Anastomosis: Patterns of Presentation and Risk Factors for Failure of Treatment

Background and Aims There is a lack in the literature about prepouch ileitis [PI], in particular regarding risk factors associated with failure of the medical treatment. Aim of the study is to analyse the characteristics of PI patients and to compare those who required surgery with those who were successfully treated with conservative therapy. Methods All cases presenting a diagnosis of PI were included and analysed. Patients eventually requiring surgery were compared with those who were managed conservatively, for symptoms of presentation, endoscopic characteristics, and rate of response to medical treatment. A sub-analysis of outcomes based on the final histology was performed. Results The overall incidence of PI among 1286 patients was 4.4% [57], after a median of 6.8 years from pouch surgery. Symptoms included increased frequency [26.4%], outlet obstruction [21%], and bleeding [15.8%]. Afferent limb stenosis affected 49.1% of patients. The comparison showed that patients requiring surgery had a higher rate of Crohns disease and indeterminate colitis [42.1 vs 0% and 15.8 vs 2.6%, p < 0.0001], outlet obstruction as main symptom [47.4 vs 7.9%, p = 0.0023], and afferent limb stenosis [73.7 vs 36.8%, p = 0.008] at endoscopy. Rate of failure of medical treatment at 5 years was 8.2% in patients with ulcerative colitis and 75% in the presence of both indeterminate colitis and Crohns disease [p < 0.0001]. Conclusions Crohns disease, indeterminate colitis, and stenosis with outlet obstruction are risk factors for failure of treatment after diagnosis of PI. Early aggressive therapy and surgery should be considered in these cases.

Endoluminal vacuum-assisted therapy as treatment for anastomotic leak after ileal pouch–anal anastomosis: a pilot study

AbstractBackgroundAnastomotic leak after ileal pouch–anal anastomosis (IPAA) could lead to poor functional results and failure of the pouch. The aim of the present study was to analyze the outcomes of the vacuum-assisted closure therapy as the unique treatment for anastomotic leaks following IPAA without any additional surgical operations. MethodsConsecutive patients with anastomotic leak after IPAA treated at our institution between March 2016 and March 2017 were prospectively enrolled. After diagnosis, the Endosponge® device was positioned in the gap and replaced until the cavity was reduced in size and covered by granulating tissue. A pouchoscopy was performed every week for the first month and monthly subsequently. No additional procedures were performed.ResultsEight patients were included in the study. The leak was diagnosed at a median of 14 (6–35) days after surgery. At the time of diagnosis, seven patients had a defunctioning ileostomy performed as routine at the time of pouch formation, while one patient was diagnosed after ileostomy closure and underwent emergency diversion ileostomy. The Endosponge® treatment started after a median of 6.5 (1–158) days after the diagnosis of the leakage and was carried on for a median of 12 (3–42) days. The device was replaced a median of 3 (1–10) times. The median length of hospital stay after the first application of the treatment was 15.5 (6–48) days. The complete healing of the leak was documented in all patients, after a median of 60 (24–90) days from the first treatment. All patients but one had their ileostomy reversed at a median of 2.5 (1–6) months from the confirmation of the complete closure.ConclusionsEndosponge® is effective as the only treatment after IPAA leak. Based on the results of our prospective pilot study, application of Endosponge® should be the treatment of choice in selected pouch anastomotic leaks not requiring immediate surgery. These results will have to be confirmed by future prospective studies including a larger number of patients.

Transabdominal salvage surgery after pouch failure in a tertiary center: A case-matched study ☆

BACKGROUND Salvage surgery after failure of ileal pouch-anal anastomosis (IPAA) could be offered to selected patients. However, the results vary widely in different centers. AIMS To assess the outcomes of salvage surgery by comparison with a control group matched for confounding variables. METHODS From a prospective database of 1286 IPAA, patients undergoing transabdominal salvage surgery were compared for perioperative and functional outcomes and quality of life (QOL) to a 1:3 control group of primary IPAA cases. RESULTS Salvage surgery patients (30) had a higher rate of hand-sewn anastomoses (80 vs 20%, p <0.0001) and reoperations (10 vs 2.2%, p 0.02) than control group (90). A higher number of daytime and nighttime bowel movements (7.4 vs 4.1, p <0.0001, and 2.6 vs 1.8, p=0.002), a lower median CGQL score (0.7 vs 0.8, p=0.0001) and a higher rate of pouch fistulae (13.3 vs 1.1%, p=0.003) were reported after salvage surgery. Pouch failure rate after salvage surgery was 10.1%, 18.7% and 26.8% at 1, 5 and 10 years (vs 0%, 3.5% and 8.4% in control group, p=0.0085). CONCLUSIONS Although worse functional outcomes and decreased QOL have to be expected, salvage surgery after pouch failure is associated with acceptable outcomes when performed in a referral center.