Laparoscopic appendectomy with single port vs conventional access: systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Conventional three-access laparoscopic appendectomy (CLA) is currently the gold standard treatment, however, Single-Port Laparoscopic Appendectomy (SILA) has been proposed as an alternative. The aim of this systematic review/meta-analysis was to evaluate safety and efficacy of SILA compared with conventional approach. METHODS: Per PRISMA guidelines, we systematically reviewed randomised controlled trials (RCTs) comparing CLA vs SILA for acute appendicitis. The randomised Mantel-Haenszel method was used for the meta-analysis. Statistical data analysis was performed with the Review Manager software and the risk of bias was assessed with the Cochrane "Risk of Bias" assessment tool. RESULTS: Twenty-one studies (RCTs) were selected (2646 patients). The operative time was significantly longer in the SILA group (MD = 7,32), confirmed in both paediatric (MD = 9,80), (Q = 1,47) and adult subgroups (MD = 5,92), (Q = 55,85). Overall postoperative morbidity was higher in patients who underwent SILA, but the result was not statistically significant. In SILA group were assessed shorter hospital stays, fewer wound infections and higher conversion rate, but the results were not statistically significant. Meta-analysis was not performed about cosmetics of skin scars and postoperative pain because different scales were used in each study. CONCLUSIONS: This analysis show that SILA, although associated with fewer postoperative wound infection, has a significantly longer operative time. Furthermore, the risk of postoperative general complications is still present. Further studies will be required to analyse outcomes related to postoperative pain and the cosmetics of the surgical scar.

Management of Acute Cholecystitis in High-Risk Patients: Percutaneous Gallbladder Drainage as a Definitive Treatment vs. Emergency Cholecystectomy-Systematic Review and Meta-Analysis.

BACKGROUND: This systematic review aims to investigate whether percutaneous transhepatic gallbladder biliary drainage (PTGBD) is superior to emergency cholecystectomy (EC) as a definitive treatment in high-risk patients with acute cholecystitis (AC). MATERIAL AND METHODS: A systematic literature search was performed until December 2022 using the Scopus, Medline/PubMed and Web of Science databases. RESULTS: Seventeen studies have been included with a total of 783,672 patients (32,634 treated with PTGBD vs. 4663 who underwent laparoscopic cholecystectomy, 343 who had open cholecystectomy and 746,032 who had some form of cholecystectomy, but without laparoscopic or open approach being specified). An analysis of the results shows that PTGBD, despite being less invasive, is not associated with lower morbidity with respect to EC (RR 0.77 95% CI [0.44 to 1.34]; I2 = 99%; p = 0.36). A lower postoperative mortality was reported in patients who underwent EC (2.37%) with respect to the PTGBD group (13.78%) (RR 4.21; 95% CI [2.69 to 6.58]; p < 0.00001); furthermore, the risk of hospital readmission for biliary complications (RR 2.19 95% CI [1.72 to 2.79]; I2 = 48%; p < 0.00001) and hospital stay (MD 4.29 95% CI [2.40 to 6.19]; p < 0.00001) were lower in the EC group. CONCLUSIONS: In our systematic review, the majority of studies have very low-quality evidence and more RCTs are needed; furthermore, PTGBD is inferior in the treatment of AC in high-risk patients. The definition of high-risk patients is important in interpreting the results, but the methods of assessment and definitions differ between studies. The results of our systematic review and meta-analysis failed to demonstrate any advantage of using PTGBD over ER as a definitive treatment of AC in critically ill patients, which suggests that EC should be considered as the treatment of choice even in very high-risk patients. Most likely, the inferiority of PTGBD versus early LC for high-risk patients is related to an association of various patient-side factor conditions and the severity of acute cholecystitis.

The intracavitary ECG method for positioning the tip of central venous catheters: results of an Italian multicenter study.

PURPOSE: The aim of this multicenter study was to assess the feasibility, safety, and accuracy of the intracavitary ECG method for real-time positioning of the tip of different types of central venous catheters. METHODS: A total of 1444 catheter insertions in adult patients were studied in eight Italian centers (539 ports, 245 PICCs, 325 tunneled CVCs, 335 non-tunneled CVCs). Patients with no visible P wave at the standard baseline ECG were excluded. Depending on the type of catheter and its purpose, the target was to position the tip either (a) at the cavo-atrial junction, or (b) in the lower third of the superior vena cava, or (c) in the upper part of the atrium. The final position was verified by a post-procedural chest x-ray. RESULTS: The method was feasible in 99.3% of all cases. There were no complications potentially related to the method itself. At the final x-ray control, 83% of all tips were positioned exactly at the target; 12.4% were positioned within 1-2 cm from the target, but still in a correct central position; only 3.8% were malpositioned. The mismatch between intra-procedural ECG method and post-procedural x-ray was significantly lower when the x-ray was taken in supine position. CONCLUSIONS: Our multicenter study confirms that the intracavitary ECG method for real time verification of tip position is accurate, safe, feasible in all adult patients and applicable to any type of short-term or long-term central venous access device.

GAVeCeLT* consensus statement on the correct use of totally implantable venous access devices for diagnostic radiology procedures.

The use of totally implantable venous access devices in radiology may be associated with complications such as occlusion of the system (because of the high density of some contrast), infection (if the port is not handled in aseptic conditions, using proper barrier protections), and mechanical complications due to the high-pressure administration of contrast by automatic injectors (so-called power injector), including extravasation of contrast media into the soft tissues, subintimal venous or myocardial injection, or serious damage to the device itself (breakage of the external connections, dislocation of the non-coring needle, or breakage of the catheter). The last problem - i.e., the damage of the device from a power injection - is not an unjustified fear, but a reality. A warning by the US Food and Drug Administration of July 2004 reports around 250 complications of this kind, referring to both port and central venous catheters and peripherally inserted central catheter systems, which occurred over a period of several years; in all cases, the damage occurred during the injection of contrast material by means of power injectors for computed tomography or magnetic resonance imaging procedures. Though the risk associated with the use of ports in radiodiagnostics is thus clear, it has been suggested that administration of the contrast material via the port may have some advantage in terms of image quality, increased comfort for the patient, and maybe more accurate reproducibility of the patient's own follow-up exams. This contention needs to be supported by evidence. Also, since many cancer patients who need frequent computed tomography studies already have totally implantable systems, it would seem reasonable to try to define how and when such systems may safely be used. The purpose of this consensus statement is to define recommendations based on the best available evidence, for the safe use of implantable ports in radiodiagnostics.

Dose-dense chemotherapy in metastatic gastric cancer with a modified docetaxel-cisplatin-5-fluorouracil regimen.

AIMS AND BACKGROUND: Previous studies have reported that in early breast cancer, lymphomas and advanced bladder cancer, dose-dense chemotherapy may be more effective than conventional treatments. In metastatic gastric cancer, chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TCF) q3w is very active, and, even though there is no international consensus on the subject, it is the regimen of choice of many European centers as first-line chemotherapy in this subset of patients. Based on these studies, we tested for the first time the feasibility and activity of an intensified dose-dense TCF regimen (q2w) modifying the 5-fluorouracil infusion with 1-folinic acid/5-fluorouracil according to the "De Gramont regimen". METHODS AND STUDY DESIGN: Patients with histologically confirmed measurable metastatic gastric cancer, ECOG performance status or=65 years received the same schedule with a dose reduction of 30%. RESULTS: Thirty-two consecutive patients were enrolled (63% male, 37% female); median age, 64 years (range, 40-81). A median of 4 cycles (range, 1-7) per patient was administered. Eleven of 32 patients (34%) required a dose reduction, mostly for hematological grade III-IV toxicity and severe asthenia. Twelve patients (38%) completed the first 4 cycles of therapy within 7 weeks, thereby finishing without delay the initially planned dose-density schedule. Twenty-eight patients were evaluated for response (1 early suspension after the first cycle because of toxicity, 3 deaths before response evaluation due to progression of disease). There were 3 complete responses (9%), 15 partial responses (47%), 7 stable disease (22%) and 3 progression of disease (9%), for an overall response rate, by intention to treat, of 56% (95% CI, 39-73). The most frequent grade 3-4 toxicities were: neutropenia (53%), thrombocytopenia (34%), anemia (16%) febrile neutropenia (22%), asthenia (38%) and diarrhea (19%). Median time to progression was 9.1 months (95% CI, 6.0-12.2); median overall survival was 10.1 months (95% CI, 8.8-12.2). CONCLUSIONS: A dose-dense TCF regimen in metastatic gastric cancer is feasible, with activity comparable to previous results achieved with epirubicin-based chemotherapy and TCF q3wk in terms of overall survival and time to progression, and deserves to be further tested in randomized phase III studies.

[Endometriosis of the caecum and ileo-caecal valve. A case report and review of the literature]. / Endometriosi del cieco e della valvola ileo-ciecale: osservazione di un caso e revisione della letteratura.

Endometriosis is a non-cancerous disorder characterised by development of endometrial epithelium outside the uterus, in which involvement of the gastrointestinal tract is most common. The most frequent site is the rectosigmoid colon (72%), whereas the caecum is involved in 4% of cases. Endometriosis may present with abdominal pain, constipation, and sometimes intestinal bleeding. The treatment of the disease is surgical when medical therapy fails and in cases of surgical urgency. We report the case of a patient with bowel obstruction due endometriosis of the caecum and ileo-caecal valve in association with metrorrhagia. A segmentectomy of the right colon was performed. Since endometriosis is more frequent on the left side of the pelvis probably due to regurgitated endometrial cells, the case observed is not very frequent and is worth reporting.

A pilot phase II study of chemotherapy with oxaliplatin, folinic acid, 5-fluorouracil and irinotecan in metastatic gastric cancer.

AIMS AND BACKGROUND: Previous phase II studies have reported that combinations of oxaliplatin, folinic acid and 5-fluorouracil or irinotecan, folinic acid and 5-fluorouracil are associated with good efficacy and an acceptable safety profile in metastatic gastric cancer. The aim of this study was to evaluate chemotherapy with oxaliplatin, folinic acid, 5-fluorouracil and irinotecan (COFFI regimen) in metastatic gastric cancer. METHODS: Patients received oxaliplatin (85 mg/m2 d 1), irinotecan (140 mg/m2 d 1), and L-folinic acid (200 mg/m2 d 1) followed by 5-fluorouracil bolus (400 mg/m2 d 1) and then 5-fluorouracil (2,400 mg/m2 48-h continuous infusion), every 14 days. RESULTS: Seventeen patients with metastatic gastric cancer were enrolled. Eight patients were pretreated for advanced disease. Of the 9 chemo-naïve patients, 8 were evaluated for response (1 patient was lost to follow-up): one complete response, 5 partial responses and 2 progressions of disease occurred, giving an overall response rate, at intention-to-treat analysis, of 67%. Of the 8 pretreated patients, 6 were evaluated for response (2 patients had nonmeasurable disease): one partial response, 2 disease stabilizations and 3 progressions of disease occurred, giving an overall response rate, at intention-to-treat analysis, of 12%. Median progression-free and overall survival in chemo-naïve patients were 8.2 and 10.2 months, respectively, and in pretreated patients 2.7 and 3 months. Grade 3-4 neutropenia occurred in 55% of chemo-naïve patients. Thrombocytopenia, and anemia were observed in 18% and 29%, respectively. Grade 3 nausea/vomiting occurred in 12% and grade 3 diarrhea in 6%. CONCLUSIONS: The COFFI regimen is active and well tolerated, therefore phase III studies are warranted.

Clinical experience on eight cases of Merkel cell carcinoma.

Merkel cell carcinoma is a rare neuroendocrine neoplasm of the skin. The tumor most frequently affects elderly patients, with a preference for the head and neck. Eight patients affected by Merkel cell carcinoma have been observed at the General Surgery Unit II of the "Istituti Ospitalieri" hospital in Cremona, each in different stages of the disease; 75% of the cases involved the extremities, and in nearly all of the cases the tumor was nodular in appearance, with an average diameter of 2.2 cm. In 2 cases, the tumor was associated with rheumatoid arthritis, suggesting a dependency on the part of the neoplasm on the immune disorder and on steroid treatment. The available data confirm that in stage I of the disease, surgical treatment should be associated with radiotherapy in order to control the development of local relapses or metastases over time. In this stage, we observed a survival of 34 months (range, 24-48). In stages II and III, survival time falls, with very short duration of responses and poor quality of life as a result of the administration of cytotoxic molecules. Bearing in mind that any local relapse tends to appear within 12 months of the removal of the primitive tumor, that lymph node metastases appear in almost half of the patients, and that metastases over time are manifested in over a third of patients, it is essential to adopt a treatment capable of balancing the demand for longer remissions with a better quality of life. In this situation, we observed that treatment with somatostatin analogues achieves interesting responses without side effects, which suggests a close biological relationship between the tumor and somatostatin and that making a careful assessment of the prognostic factors of the disease can guarantee a correct therapeutic choice.

Tension-free inguinal hernia repair in "one-day surgery". Experience of 1091 cases.

BACKGROUND/AIMS: In recent years new techniques to repair inguinal hernia have evolved in order to reduce recurrence rate and the overall costs of treatment of this pathology. This paper analyses our experience in verifying the theoretical advantages of the "tension-free" technique, after six years of this surgical practice. METHODOLOGY: We describe the experience of 1091 "tension-free" hernia repairs with open placement of a mesh in 1034 patients, under local anesthesia with a "one-day surgery" regimen; these patients were observed during the period 1994 to 1999 at the Surgical Unit of Catholic University of Rome. The patients were between American Society of Anesthesia Status I to IV. Eight hundred patients underwent a mean follow-up of 29.7 months (range: 4-72) to evaluate the occurrence of late complications and recurrences. RESULTS: No mortality or major intraoperative complications was observed. The only minor intraoperative or postoperative complications encountered were easily managed. Early pain disappearance, fast convalescence and rapid resumption of working activity were observed. Six recurrences occurred in the patients undergoing follow-up (0.75% recurrence rate). CONCLUSIONS: Our data confirm the safety, rapidity, and reproducibility of the "tension-free" technique under local anesthesia performed with a "one-day surgery" regimen for inguinal hernia repair. These characteristics explain the diffusion of this surgical procedure with reduction of social costs.