Matteo Sacchi

Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial

Objective:To evaluate the role of an absorbable fibrin sealant patch (TachoSil) in reducing postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP). Background:POPF remains the main complication after DP. Methods:This was a prospective, open, randomized, study in which patients undergoing elective DP were randomized to standard surgical suturing or stapling with or without TachoSil. The primary end point was the incidence of POPF according to International Study Group on Pancreatic Fistula criteria. Amylase level in drainage fluid, number of days until removal of drain, and duration of hospital stay were secondary end points. Results:A total of 275 patients were enrolled at 19 centers over a 2-year period (TachoSil, n = 145; standard, n = 130). Twenty percent of procedures were laparoscopic and 21% were spleen-preserving resections. The incidence of POPF was not significantly different between groups (TachoSil, 62%; standard 68%; P = 0.267). Grade A fistula rate was similar in both groups (TachoSil 54%; standard 55%), whereas the grade B + C fistula rate was 8% with TachoSil versus 14% without (P = 0.139). Amylase drainage level on postoperative day 1 was significantly reduced with TachoSil (P = 0.025). Median number of days until drainage removal and length of hospital stay were similar in both groups (7 and 10 days, respectively). Conclusions:The POPF rate was higher than expected when International Study Group on Pancreatic Fistula criteria were strictly applied, although the majority were biochemical fistulas. TachoSil had no significant effect on the rate of POPF, although there was a significant reduction of amylase level in drainage fluid on postoperative day 1.

Risk of postoperative recurrence and postoperative management of Crohn's disease.

Crohns disease (CD) is a chronic inflammatory disease of the digestive tract with systemic manifestations. Etiology is unknown, even if immunological, genetic and environmental factors are involved. The majority of CD patients require surgery during their lifetime due to progressive bowel damage, but, even when all macroscopic lesions have been removed by surgery, the disease recurs in most cases. Postoperative management represents therefore a crucial mean for preventing recurrence. Several drugs and approaches have been proposed to achieve this aim. Endoscopic inspection of the ileocolic anastomosis within 1 year from surgery is widely encouraged, given that endoscopic recurrence is one of the greatest predictors for clinical recurrence. A strategy should be planned only after stratifying patients according to their individual risk of recurrence, avoiding unnecessary therapies when possible benefits are reduced, and selecting high-risk patients for more aggressive intervention.

Multimodal treatment of perianal fistulas in Crohn’s disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial

BackgroundCurrently there is no guideline for the treatment of patients with Crohn’s disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs.Methods/DesignThis is a multicentre, randomized controlled trial. Patients with Crohn’s disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs.DiscussionThe PISA trial is a multicentre, randomised controlled trial of patients with Crohn’s disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters.Trial registrationNederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).

Risk factors for complications after ileocolonic resection for Crohn’s disease with a major focus on the impact of preoperative immunosuppressive and biologic therapy: A retrospective international multicentre study

Background Author note: TY, AS, YS, FVT and PGK designed the study. All authors did data collection and gave scientific contribution to the study design and discussion. TY, AS and PGK drafted the article. All authors read and approved the final version of the manuscript. In the era of biologic agents, risk factors for complications following resection for Crohn’s disease have not been fully identified. In particular, the association of preoperative use of immunosuppressive and biologic agents with the incidence of complications after resection remains to be elucidated. Aim This retrospective multicentre study aimed to identify risk factors for complications after ileocolonic resection for Crohn’s disease, with a major focus on the impact of preoperative immunosuppressive and biologic therapy. Methods A total of 231 consecutive patients who underwent ileocolonic resections for active Crohn’s disease in seven inflammatory bowel disease referral centres from three countries (Japan, Brazil and Italy) were included. The following variables were investigated as potential risk factors: age at surgery, gender, behaviour of Crohn’s disease (perforating vs. non-perforating disease), smoking, preoperative use (within eight weeks before surgery) of steroids, immunosuppressants and biologic agents, previous resection, blood transfusion, surgical procedure (open vs. laparoscopic approach), and type of anastomosis (side-to-side vs. end-to-end). Postoperative complications occurring within 30 days after surgery were recorded. Results The rates of overall complications, intra-abdominal sepsis, and anastomotic leak were 24%, 12% and 8%, respectively. Neither immunosuppressive nor biologic therapy prior to surgery was significantly associated with the incidence of overall complications, intra-abdominal sepsis or anastomotic leak. In multivariate analysis, blood transfusion, perforating disease and previous resection were significant risk factors for overall complications (odds ratio [OR] 3.02, 95% confidence interval [CI] 1.21–7.52; P = 0.02), intra-abdominal sepsis (OR 2.67, 95% CI 1.04–6.86; P = 0.04) and anastomotic leak (OR 2.87, 95% CI 1.01–8.18; P = 0.048), respectively. Conclusions Blood transfusion, perforating disease and previous resection were significant risk factors for overall complications, intra-abdominal sepsis and anastomotic leak after ileocolonic resection for Crohn’s disease, respectively. Preoperative immunosuppressive or biologic therapy did not increase the risk of postoperative complications.

Retractor plication versus retractor plication and lateral tarsal strip for eyelid entropion correction

Purpose: Involutional entropion is a common lower lid malposition. Addressing both the horizontal and the vertical lower eyelid laxity in patients with involutional entropion seems to have a more long-lasting effect on maintaining lower eyelid stability; however, there is some disagreement as to which approach is the best surgical intervention. The aim of this study was to determine differences in the surgical outcome of Jones retractor plication (JRP) alone versus Jones retractor plication with a lateral tarsal strip (JRP + LTS) for the treatment of involutional entropion. Methods: A retrospective case series comparison of 118 patients with primary involutional lower eyelid entropion was performed. Jones retractor plication alone was performed in 61 patients, and JRP + LTS in 57 patients. The baseline characteristics of the 2 groups were similar. Patients were retrospectively evaluated from a retrospective case-note review 3 weeks and 6, 12, 18, and 24 months postoperatively. Successful surgery was defined as a normal eyelid position. Results: A total of 115 patients fulfilled the inclusion criteria, 60 in the JRP group and 55 in the JRP + LTS group. Ten patients (16.5%) in the JRP group and 2 patients (3.5%) in the JRP + LTS group had a recurrence of the entropion at or before their 24-month follow-up visit (p = 0.03). Conclusions: These data provide strong evidence that the success rate at 24 months is higher in patients treated with the JRP + LTS procedure compared with JRP alone.

Circulating Inflammatory Mediators as Potential Prognostic Markers of Human Colorectal Cancer.

Background Cytokines and chemokines in the tumor microenvironment drive metastatic development and their serum levels might mirror the ongoing inflammatory reaction at the tumor site. Novel highly sensitive tools are needed to identify colorectal cancer patients at high risk of recurrence that should be more closely monitored during post-surgical follow up. Here we study whether circulating inflammatory markers might be used to predict recurrence in CRC patients. Methods Circulating levels of the inflammatory cytokines IL-1, IL-6, IL-10, TNFalpha, CCL2, CXCL8, VEGF and the acute phase protein Pentraxin-3 were measured by ELISA in preoperative serum samples prospectively collected from a cohort of sixty-nine patients undergoing surgical resection for stage 0–IV CRC and associated with post-operative disease recurrence. Results Cox multivariate analysis showed that combined high levels (≥ROC cut off-value) of CXCL8, VEGF and Pentraxin3 were associated with increased risk of disease recurrence [HR: 14.28; 95%CI: (3.13–65.1)] independently of TNM staging. Kaplan-Meier analysis showed that CXCL8, VEGF and Pentraxin3 levels were significantly associated with worse survival (P<0.001). Conclusions Circulating inflammatory mediators efficiently predicted postoperative recurrence after CRC surgery. Therefore, this study suggest that their validation in large-scale clinical trials may help in tailoring CRC post-surgical management.

Corneal Involvement in Uneventful Cataract Surgery: An in vivo Confocal Microscopy Study

Purpose: To evaluate corneal subbasal layer changes after uneventful cataract surgery by means of in vivo confocal microscopy. Methods: This prospective study included 30 patients. Before surgery, and 1, 3, 6, 8 and 10 months after cataract surgery, all patients underwent a complete ophthalmological and confocal microscopy examination in the central and temporal corneal areas. Number of fibers, beading, tortuosity and reflectivity were analyzed. Results: Important changes were shown in the central cornea up to 3 months after surgery: a reduction in nerve fiber number (baseline: 4.4 ± 1.7; month 1: 1.2 ± 0.5, p < 0.0001; month 3: 2.5 ± 1.2, p < 0.005) and reflectivity (baseline: 3.6 ± 0.5; month 1: 1.4 ± 0.6, p < 0.0001; month 3: 1.9 ± 0.9, p < 0. 0001), and an increase in beading (baseline: 0.3 ± 0.5 beads/100 µm2; month 1: 2.7 ± 0.6 beads/100 µm2, p < 0.0001; month 3: 2.6 ± 0.5 beads/100 µm2, p < 0. 0001). The confocal parameters completely progressively recovered thereafter (60% at 6 months, 87% at 8 and 10 months). The temporal plexus was absent at 1 month and fully recovered in all patients at month 8. Conclusion: Uneventful cataract surgery induces relevant corneal modifications when inspected by means of confocal microscopy.

A Prospective Study Evaluating IOP Changes after Switching from a Therapy with Prostaglandin Eye Drops Containing Preservatives to Nonpreserved Tafluprost in Glaucoma Patients

Purpose. To compare the ocular hypotensive effect of tafluprost with prostaglandin analogues (PGAs) in glaucoma patients. Methods. 89 primary open-angle glaucoma patients treated with bimatoprost, latanoprost, or travoprost for at least 3 months complaining for ocular discomfort were switched to tafluprost. IOP was assessed at baseline and 3 months after switching the therapy by daily curve. Primary outcome was to compare the mean daily IOP of tafluprost with PGAs. Results. The mean daily IOP was 16 ± 2.1 and 16.6 ± 2.0 mm Hg at baseline and after switching to tafluprost, respectively (P > 0.05). When analysis was carried out between tafluprost and each previous PGAs, the comparison between latanoprost and tafluprost and travoprost and tafluprost did not show any statistically significant difference in mean daily IOP and at each time point. The comparison between bimatoprost and tafluprost showed a statistically significant difference in mean daily IOP (P < 0.05) and at each time point (P < 0.05). Conclusions. After 3 months of switching tafluprost showed an overall IOP lowering effect similar to others PGAs. When each PGA was compared with tafluprost, bimatoprost showed to provide a statistically significant additional IOP lowering effect.

The ocular surface in medically controlled glaucoma: An in vivo confocal study

PURPOSE To study clinical and in vivo laser scanning confocal microscopy (LSCM) ocular surface findings in stable, medically controlled primary open-angle glaucoma (MCPOAG) patients. METHODS We recruited 100 consecutive patients with MCPOAG and 50 healthy controls. Patients had to have been treated with the same medical regimen without variation for the 18 months before enrollment and were excluded if there was a history of dry eye prior to glaucoma diagnosis. Each participant underwent ocular surface clinical and LSCM examination. RESULTS In MCPOAG patients, subbasal nerve length and tortuosity and dendritic cell density were increased compared to controls (P < 0.01), but there were no clinical abnormalities. Patients treated with preserved drugs (n = 80) had reduced tear film breakup time (P < 0.05, ANOVA), and those preserved with benzalkonium chloride (n = 72) had reduced Schirmer test values (P < 0.001). Patients (n = 50) treated with two or more drugs had increased lissamine green conjunctival staining (P < 0.001, LSD post hoc test). Patients (n = 29) treated with three or more eye drops daily had decreased Schirmer test values. Laser scanning confocal microscopy showed subbasal changes related to preservatives, type and number of drugs, and number of eye drops. CONCLUSIONS In stable MCPOAG patients without dry eye history, the ocular surface changes due to antiglaucoma medications are mostly subclinical. Active ingredients, preservatives, number of concomitant drugs, and number of eye drops instilled per day are all elements that can induce ocular surface changes. The clinical relevance of these changes remains to be determined.

Efficacy of intravitreal dexamethasone implant for prostaglandin-induced refractory pseudophakic cystoid macular edema: case report and review of the literature

Background Macular edema is a known complication even after uneventful cataract surgery. The chronic use of prostaglandin analogs is a risk factor for the development of pseudophakic cystoid macular edema (CME). Nonsteroidal anti-inflammatory drugs (NSAIDs) are considered first-line therapy but refractory postsurgical CME represents a therapeutic challenge, as there is not an evidence-based treatment. Objective To report the use of a single implant of intravitreal dexamethasone for tafluprost-associated pseudophakic CME refractory to NSAIDs and to sub-Tenon’s corticosteroid injections. Case report A 64-year-old female with ocular hypertension treated with tafluprost experienced decreased vision (visual acuity 20/60) and metamorphopsia 2 months after uneventful cataract extraction. Spectral domain optical coherence tomography (SD-OCT) revealed CME. After 1 month of topical and oral NSAIDs, CME was still evident on SD-OCT (visual acuity 20/50). Two sub-Tenon’s betamethasone injections were performed at a 2-week interval. As CME was still present, 2 months after the diagnosis of CME (visual acuity 20/40), the patient underwent a single dexamethasone intravitreal implant. One month later, macular appearance was normal, and visual acuity increased to 20/30. This result was maintained throughout the 6 months of follow-up. Conclusion In this report, a single implant of intravitreal dexamethasone successfully treated pseudophakic CME associated with the use of prostaglandin analogs unresponsive to NSAIDs and sub-Tenon’s betamethasone. The results of this report need to be corroborated by powered, prospective, randomized trials. The need for repeated treatments as well as the retreatment interval in patients requiring more than a single injection are issues still needing further investigations.