Pilonidal sinus disease. A single center retrospective series analysis.

The surgical approach to chronic pilonidal disease has been significantly changed by minimally invasive and targeted procedures, with the aim to minimize costs and favoring less dressings, faster recovery, and prompt return to work or to school activity. Less invasive procedures are gaining wide acceptance as first approach. We present a single-center experience with the Gips technique, also called Israeli technique or trephine technique, and a brief review of the literature, focusing on minimally invasive procedures. KEY WORDS: Pilonidal Disease, Punch, Minimally Invasive Surgery, Trephines.

Predictive factors for 6 vs 12 cycles of Folfiri-Bevacizumab in metastatic colorectal cancer.

Early switching to de-intensified maintenance regimen is still a matter of debate in metastatic colorectal cancer (mCRC). The MARTHA trial, a S.I.C.O.G. phase III randomized trial, compared FOLOFIRI+bevacizumab (B) for 12 cycles (6 months) followed by B for up to 12 months (FOLFIRI +B*12 arm) vs FOLFIRI+B for 6 cycles (3 months) followed by capecitabine+B for 4 cycles followed by B for up to 12 months (FOLFIRI+B*6 arm). Chemotherapy-naïve mCRC patients were randomized, primary endpoint was progression free survival (PFS), with overall survival (OS) as a secondary endpoint. A novel analysis, the Death Pace Analysis (DPA), was performed to identify patients who benefited from a specific treatment. No PFS difference was seen in 198 enrolled patients (101 in FOLFIRI+B*12, 97 in FOLFIRI+B*6). A non-significant superior OS was observed for FOLFIRI+B*6 (HR 0.74, p 0.098). The DPA demonstrated that 14% of patients were identifiable as FOLFIRI+B*6-benefiting patients. According to a logistic regression analysis including 23 clinicopathological variables, baseline Hb was the only independent predictor of DPA-defined FOLFIRI+B*6-benefit status. Among patients with Hb ≤ 11.1 gr/dL a statistically significant prolonged OS was observed for FOLFIRI+B*6 over FOLFIRI+B*12 (median OS: 20.7 vs 12.6 months, respectively, HR 0.54, p 0.048). No survival difference was observed between arms in patients with Hb > 11.1. mCRC patients with low baseline Hb levels are better treated with FOLFIRI+B*6 first-line strategy. Possible biological explanations for this finding are being investigated.

T2238C ANP gene variant and risk of recurrent acute coronary syndromes in an Italian cohort of ischemic heart disease patients.

BACKGROUND: The role of C2238/atrial natriuretic peptide (ANP) minor allele, at the T2238C ANP gene variant, as a predisposing risk factor for acute cardiovascular events, has been previously reported. We aimed at evaluating, by a retrospective approach, the long-term impact of C2238/ANP-minor allele carrier status toward the risk of recurrent acute coronary syndromes (re-ACS) in an Italian cohort of ischemic heart disease patients. METHODS: A total of 379 patients (males = 80.5%; mean age = 62.5 ±â€Š9.2 years) presenting with ACS were retrospectively analyzed. Mean follow-up was 5.1 ±â€Š3.5 years (range 1-26 years). Occurrence of new episodes of unstable angina, non-ST-segment elevation myocardial infarction and STE myocardial infarction over the years was recorded and compared between subjects not carrying and carrying C2238/ANP-minor allele. RESULTS: At univariate analysis, C2238/ANP-minor allele carrier status and treatment with beta-blocker, aspirin and statin were associated with risk of re-ACS. Multivariate analysis confirmed that hypercholesterolemia (P < 0.0001) and C2238/ANP-minor allele carrier status (P < 0.05) were both significantly and independently associated with increased risk of re-ACS. Both treatments with beta-blocker and with statin were significantly associated with reduced risk of re-ACS (P = 0.01 and P < 0.01, respectively). Age above 55 years was associated with recurrence of ACS in C2238/ANP-minor allele carriers (hazard ratio 1.427, 95% confidence interval 1.066-1.911, P = 0.017). Kaplan-Meier curves confirmed highest risk of new events occurrence in C2238/ANP-minor allele carriers (P = 0.035). CONCLUSIONS: The present results demonstrate that C2238/ANP-minor allele carrier status is an independent risk factor for ACS recurrence in an Italian cohort of ischemic heart disease patients over the long term, and they support the role of C2238/ANP-minor allele as a negative prognostic factor in coronary artery disease patients.

Clinical Outcome Following Hemorrhoid Surgery: a Narrative Review.

Surgical therapy guaranties satisfactory results, which are significantly better than those obtained with conservative therapies, especially for Grade III and IV hemorrhoids. In this review, we present and discuss the results of the most diffuse surgical techniques for hemorrhoids. Traditional surgery for hemorrhoids aims to remove the hemorrhoids, with closure (Fergusson's technique) or without closure (Milligan-Morgan procedure) of the ensuing defect. This traditional approach is effective, but causes a significant postoperative pain because of wide external wounds in the innervated perianal skin. Stapled hemorrhoidopexy, proposed by Longo, has gained a vast acceptance because of less postoperative pain and faster return to normal activities. In the recent literature, a significant incidence of recurrence after stapled hemorrhoidopexy was reported, when compared with conventional hemorrhoidectomy. Double stapler hemorrhoidopexy may be an alternative to simple stapled hemorrhoidopexy to reduce the recurrence in advanced hemorrhoidal prolapse. Transanal hemorrhoidal deartertialization was showed to be as effective as stapled hemorrhoidopexy in terms of treatment success, complications, and incidence recurrence. However, further high-quality trials are recommended to assess the efficacy and safety of this technique.

Antibiotic prophylaxis in elective laparoscopic cholecystectomy is useless. A prospective multicenter study.

AIM: We performed a prospective study to evaluate the effect of antibiotic prophylaxis (AP) on the incidence of infection in elective laparoscopic cholecystectomy (LC). MATERIAL OF STUDY: All patients were at low-medium anesthetic and infectious risk and underwent LC for benign disease. At induction of anesthesia 41 patients received ampicillin-sulbactam 3g, 40 patients received ciprofloxacin 400mg intravenously, and 53 patients received no AP. RESULTS: Postoperative infection was observed in 11 patients (8.2%) in the entire study group. All ob served infections were superficial surgical site infections (SSIs), always located at the umbilical incision. Infection occurred in 3 patients (7.3%) in ampicillin-sulbactam group, in 3 patients (7.5%) in ciprofloxacin group and in 5 patients (9.4%) in nonantibiotic group (p=0.916). Univariate analysis showed that duration of operation, placement of a drain and postoperative hospital stay were significantly associated with the development of SSIs. At multivariate analysis, only duration of operation was statistically significant in predicting SSIs. DISCUSSION: The present study did not show any advantage in the use of AP, although in case of difficult surgery the risk of SSIs is increased, in particular in the umbilical incision. In all patients, the bile culture was sterile, then the infection of the umbilical site is not due to bacterial infection from the gallbladder. CONCLUSIONS: AP in elective LC should not be routinely performed. A particular attention to the preoperative cleaning and topical antibiotic therapy of the umbilical area is advised.

Anti-vascular endothelial growth factor drugs safety and efficacy in ophthalmic diseases.

Macular degeneration is the leading cause of blindness in developed countries. In the treatment of neovascular age-related macular degeneration, vascular endothelial growth factor (VEGF) has emerged as a key target for therapy. The intravitreal injection of anti-VEGF drugs has been widely employed to reduce the disease progression and improve the visual outcomes of the affected patients. However, each intravitreal inoculation poses a risk of several complications as infection, inflammation, endophthalmitis, intraocular inflammation, increase of intraocular pressure and vitreous hemorrhage. This short review evaluates the efficacy and the incidence of adverse drug reactions related to intravitreal administration of the main anti-VEGF drugs actually available: Bevacizumab, ranibizumab and aflibercept.

PPH-01 versus PPH-03 to perform STARR for the treatment of hemorrhoids associated with large internal rectal prolapse: a prospective multicenter randomized trial.

PURPOSE: This multicenter randomized study was designed to compare the clinical and functional results of stapled transanal rectal resection (STARR) performed with 2 staplers (PPH-01 vs. PPH-03) in the treatment of hemorrhoidal disease associated with a large internal rectal prolapse. METHODS: From a total of 937 patients, referred for hemorrhoidal disease in the 20 centers involved in the study, 425 (45.3%) with prolapsed hemorrhoids associated with a large internal rectal prolapse were randomized to undergo STARR with PPH-01 or PPH-03. Postoperative evaluation was made at 3, 6, and 12 months. RESULTS: The incidence of bleeding at the stapled line was significantly lower in the PPH-03 group than in the PPH-01 group (58/207 [28.0%] vs. 145/201 [72.1%]; P < .0001); the mean number of hemostatic stitches was significantly higher in the PPH-01 than in the PPH-03 group (3.2 ± 0.1 vs. 1.8 ± 0.8; P < .0001). The mean operative time was 25.1 ± 11.5 minutes in the PPH-03 group and 38.1 ± 15.7 minutes in the PPH-01 group (P < .0001). No major complications occurred in either of the groups. At 12-month follow-up, the success rate in the 2 groups was 94.5% in the PPH01 group and 94.2% in the PPH03 group. CONCLUSION: STARR performed for the treatment of hemorrhoidal disease associated with a large rectal prolapse is a safe and effective procedure. The use of the PPH-03 stapler instead of the PPH-01 guarantees a statistically significant reduction of intraoperative bleeding and a significant decrease of the operative time.

Gemcitabine combined with either pemetrexed or paclitaxel in the treatment of advanced non-small cell lung cancer: a randomized phase II SICOG trial.

PURPOSE: To estimate the safety, activity, and impact on quality of life of a combination of gemcitabine and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in the context of a randomized two-stage phase II study. PATIENTS AND METHODS: Patients in stage IIIB or IV NSCLC were randomly allocated to receive either gemcitabine 1250 mg/m(2) on day 1, and pemetrexed (Alimta) 500 mg/m(2) followed by gemcitabine 1250 mg/m(2) on day 8 of a 3-weekly cycle (GA arm), or paclitaxel 120 mg/m(2) followed by gemcitabine 1000 mg/m(2), both given on days 1 and 8 of a 3-weekly cycle (PG arm). RESULTS: 105 (GA arm, 51; PG arm, 54) eligible patients (stage IV, 32 and 30, respectively) were enrolled into this study; thereafter, accrual was stopped due to first-stage analysis. The response rate was 20% (95% confidence interval [CI], 10-33%) in the GA arm, and 32% (95% CI, 20-46%) in the PG arm. Median progression-free survival was 5.1 (95% CI, 3.7-6.5) months in the GA arm, and 8.3 (95% CI, 5.9-10.7) months in the PG arm, while median overall survival was 10.5 (95% CI 7.1-13.9), and 13.3 (95% CI 11.7-14.9) months, respectively. Severe neutropenia (36% vs 22%), and febrile neutropenia (14% vs 7%) were more common with the GA regimen, while hair loss (52% vs 16%) and any grade peripheral neuropathy (31% vs 2%) occurred more frequently with PG regimen. Other severe side effects of GA regimen were diarrhoea (10%), liver enzyme derangement (10%), and fatigue (8%). CONCLUSION: The GA regimen was tolerated and moderately active in advanced or metastatic NSCLC. However, this combination did not yield any advantage in comparison with the PG regimen, and does not deserve further evaluation.

Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group.

PURPOSE: This phase II trial assessed the tolerability and efficacy of a triplet of oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer. METHODS: Patients with unresectable or metastatic gastric cancer, unexposed to palliative chemotherapy, received oxaliplatin 85 mg/m(2) iv and irinotecan 150 mg/m(2) iv on day 1, 6S-folinic acid 250 mg/m(2) iv and fluorouracil 750 mg/m(2) iv on day 2, every 2 weeks. Response rate (RR) was assessed after a minimum of four cycles, and treatment continued up to 12 cycles. RESULTS: Sixty-three patients were treated, with a median of eight (range 1-12) cycles/patient. Two complete and 19 partial responses were registered (RR 33% [95% CI, 22-46%]). Median progression-free survival was 7.5 (95% CI, 5.6-9.4) months, and median overall survival was 12.1 (95% CI, 10.8-13.4) months. Most common grade > or =3 toxicities were neutropenia (59%), febrile neutropenia (7%), vomiting (20%), and diarrhoea (10%). All-grade neurotoxicity affected 33% of patients. CONCLUSIONS: Oxaliplatin, irinotecan, and fluorouracil/folinic acid administered every 2 weeks are safe and active in advanced gastric cancer.

Gemcitabine (GEM) plus oxaliplatin, folinic acid, and 5-fluorouracil (FOLFOX-4) in patients with advanced gastric cancer.

BACKGROUND AND AIMS: oxaliplatin in combination with folinic acid (FA) and infusional 5-fluorouracil (5-FU) has shown significant anti-tumor activity in gastric cancer patients (FOLFOX). Previous studies have shown that gemcitabine (GEM), a new fluorinated anti-metabolite, enhances the individual anti-tumor activity of either 5-FU or oxaliplatin. We have therefore designed a multi-center phase II trial in order to test a novel GEM+FOLFOX-4 regimen in patients with metastatic gastric cancer. METHODS: we enrolled 36 patients, 28 males and 8 females, with an average age of 64.4 years (range 37-78), who received bi-weekly treatment with GEM (1,000 mg/m2 on day 1), levo-FA (100 mg/m2 on days 1 and 2), a 5-FU (400 mg/m2) bolus injection followed by 22-h continuous infusion (800 mg/m2) on days 1 and 2, and oxaliplatin 85 mg/m2 in a 4-6 h intravenous (i.v.) infusion before the second FUFA administration on day 2. RESULTS: the most frequent side effect was grade 1-2 hematological toxicity and late sensorial neurotoxicity. Two patients developed hypersensitivity to oxaliplatin while another developed an aseptic eosinophilic pneumonitis. Two patients refused to continue the treatment after two cycles of chemotherapy and were lost at the follow-up. Among the remaining 34 patients four achieved a complete response, 15 a partial response, 12 had a stable disease and three progressed. CONCLUSIONS: these results may grant the rationale to evaluate this multi-drug combination in randomized phase III trials in advanced gastric cancer.

[Our experience with the treatment of high perianal fistulas with the mucosal flap advancement technique]. / Trattamento delle fistole perianali alte con la tecnica del lembo mucoso di avanzamento.

The authors present their experience with the treatment of high transphincteric anal fistulas with the mucosal flap advancement technique. This technique, though by no means easy to perform, allows fistulas to be treated in a single surgical session in comparison to the technique in which setone is used or to the less well known transposition techniques, given the same long-term results in terms of continence and recurrence rate. After a brief overview of the problem, from the points of view of both aetiopathogenesis and classification, the principal surgical treatment techniques are described, presenting the results and complications observed in the authors' own case series.