Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS).

BACKGROUND: Incisional hernia is a frequent postoperative complication after midline laparotomy. Prophylactic mesh augmentation in abdominal wall closure after elective surgery is recommended, but its role in emergency surgery is less well defined. METHODS: This prospective randomized trial evaluated the incidence of incisional hernia in patients undergoing urgent midline laparotomy for clean-contaminated surgery. Closure using a slowly absorbable running suture was compared with closure using an additional sublay mesh (Parietex ProGrip™). Patients were randomized just before abdominal wall closure using computer-generated permuted blocks. Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to the group allocation. Patients were followed up for 24 months by means of clinical and ultrasonographic evaluations. RESULTS: From January 2015 to June 2018, 200 patients were randomized: 100 to primary closure (control group) and 100 to Parietex ProGrip™ mesh-supported closure (mesh group). Eight patients in the control group and six in the mesh group were lost to follow-up. By 24 months after surgery, 21 patients in the control group and six in the mesh group had developed incisional hernia (P = 0.002). There was no difference between groups in the incidence of haematoma (2 versus 5; P = 0.248) and superficial wound infection (4 versus 5; P = 0.733). Multivariable analysis confirmed the role of mesh in preventing incisional hernia (odds ratio 0.11, 95 per cent c.i. 0.03 to 0.37; P < 0.001). One patient in the mesh group required mesh removal because of deep infection. CONCLUSION: Prophylactic mesh-augmented abdominal wall closure after urgent laparotomy in clean-contaminated wounds is safe and effective in reducing the incidence of incisional hernia. Registration number: NCT04436887 (http://www.clinicaltrials.gov).

Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospective trial.

BACKGROUND: Incisional hernia (IH) is one of the most common sequelae of laparotomy. MATERIALS AND METHODS: We present a double-blind randomized study examining feasibility, safety and incisional hernia rate using a prophylactic Bio-A biosynthetic stripe (Gore) in a sub-lay position after midline laparotomy in patients undergoing operations in clean-contaminated and contaminated field. One hundred patients who underwent a midline laparotomy of at least 10 cm in a clean-contaminated and contaminated field were considered. Patients were divided into two groups: [Group A closed in double layer using PDS 0 with WL/SL of 1:4; Group B closure in double layer using PDS 0 and sub-lay positioning a 3 cm-wide BIO A (Gore) strip extended for the entire length of the incision]. The primary objective of the study was to identify IH rate in the two groups at 1- and 2-year follow-up. Secondary objective was to identify any differences in the two groups in terms of post-operative pain, morbidity and mortality. RESULTS: Out of a total of 100 patients included in the study, a 2-year follow-up was possible for 47 patients in group A and 45 in group B. The incidence of IH was 11/47 in group A (22%) and 3/45 in group B (6%) [p < 0.01]. Furthermore, no statistically significant difference was noted about post-operative morbidity and pain related to the wall closure method. CONCLUSIONS: The prophylactic use of a BIO-A biosynthetic stripe (Gore) showed a statistically significant reduction in the incisional hernia rate in patients who underwent clean-contaminated and contaminated surgery.

Open tension-free Lichtenstein repair of inguinal hernia: use of fibrin glue versus sutures for mesh fixation.

PURPOSE: To investigate pain and other complications following inguinal hernioplasty performed by the Lichtenstein technique with mesh fixation by fibrin glue or sutures. METHODS: Five hundred and twenty patients were enrolled in this 12-month observational multicenter study and received either sutures or fibrin glue (Tissucol(®)/Tisseel(®)) based on the preference of the surgeon. Pain, numbness, discomfort, recurrence, and other complications were assessed postoperatively and at 1, 3, 6, and 12 months. Pain intensity was assessed by a visual analog scale (VAS; 0 [no pain] to 10 [worst pain]). RESULTS: One hundred and seventy-one patients received sutures and 349 received fibrin glue. During the early postoperative phase, 87.4% of patients in the fibrin glue group and 76.6% of patients in the sutures group were complication-free (P = 0.001). Patients who received fibrin glue were also less likely to experience hematoma/ecchymosis than those in the suture group (both P = 0.001). The mean pain score was significantly lower in the fibrin group than the sutures group (2.5 vs. 3.2, P < 0.001). At 1 month, significantly fewer patients in the fibrin glue group reported pain, numbness, and discomfort compared with patients in the sutures group (all P < 0.05). Fibrin glue patients also experienced less intense pain (0.6 vs. 1.2; P = 0.001). By 3 months, the between-group differences had disappeared, except for numbness, which was more prevalent in the sutures group. By 12 months, very few patients reported complications. CONCLUSIONS: Tissucol fibrin glue for mesh fixation in the Lichtenstein repair of inguinal hernia shows advantages over sutures, including lower incidence of complications such as pain, numbness, and discomfort, and should be considered as a first-line option for mesh fixation in hernioplasty.

Incidence of surgical site infections in general surgery in Italy.

BACKGROUND: Epidemiological study to determine surgical site infection (SSI) rates in surgical patients in Italy using the National Nosocomial Infections Surveillance system (NNIS), to monitor current surgical antimicrobial prophylaxis, and to identify possible modifiable risk factors for SSI. MATERIALS AND METHODS: Thirty-two general surgeries participated in the study. Main criteria for site inclusion were: > 20 operations per week and amoxycillin/clavulanate among prophylactic options. Each patient operated from April 1st to May 30th 2002 was surveyed until 30 days after the operation. SSI cumulative incidence rates and 95% confidence intervals (95%CI) were calculated. RESULTS: During the study period, 3,066 surgical procedures were performed in 2,972 patients. A total of 158 SSI were diagnosed in 154 patients: 96 (62.3%) were at superficial incision, 23 (14.9%) were at deep incision and 35 (22.7%) were at organ-space site. Incidence of SSI every 100 operations was 5.2% (95% CI 4.4-6.0). Of the 2,437 operated patients with clean or elective clean/contaminated or contaminated surgical procedure, 2,105 (86.4%) received antimicrobial prophylaxis, mainly amoxicillin/clavulanate (28.3%) and ceftizoxime (11.4%). Pre-operative hospital stay > or = 48 h, diabetes, obesity, and HIV/AIDS infection were statistically significantly associated with increased risk of SSI. CONCLUSIONS: The SSI rates found are comparable with European studies and can be a benchmark for national incidence data and for inter- and intra-hospital SSI rate comparisons.

A pilot study on prevention of catheter-related urinary tract infections with fluoroquinolones.

The objective of this multicenter, randomized, controlled, parallel group trial was to evaluate the efficacy of levofloxacin 250 mg oral, once daily (LVFX), placebo one tablet oral once daily (Placebo [P] group) and ciprofloxacin (CPFX) 500 mg oral, twice daily (single blind), prophylaxis in preventing bacteriuria (> or = 10(3) CFU/ml) in post-surgical catheterized patients. In the modified intention-to-treat (M-ITT) population of the 82 enrolled patients, negative bacteriuria was observed in 92% of LVFX group, in 80% of P group and in 100% of CPFX group while in the per-protocol (PP) population figures were: 100%, 86.4% and 100% respectively. Only one symptomatic urinary tract infection and one surgical wound infection were observed in the P group. Both drugs were well tolerated, showing a safety profile comparable to placebo. The high frequency of negative bacteriuria in the placebo group sounds encouraging as it underlines that the adoption of closed urinary drainage system catheters in hospital setting may reduce the frequency of hospital-acquired infections.

Antibiotic prophylaxis in hernia repair and breast surgery: a prospective randomized study comparing piperacillin/tazobactam versus placebo.

Although antibiotic prophylaxis is not explicitly indicated for hernia repair and breast surgery, its use for these clean procedures is widely adopted, albeit to a different extent in different countries, often on the personal decision of the individual surgeon. The present study was carried out to compare the efficacy of a single pre-operative dose of piperacillin-tazobactam with placebo in preventing surgical wound infections and to determine the main risk factors associated with infections following two main elective surgical clean procedures such as hernia repair and breast surgery.A total of 501 patients undergoing elective inguinal/femoral hernia repair or breast surgery were enrolled in this prospective randomized clinical study. Patients were randomly assigned to receive preoperative antibiotic prophylaxis or placebo. One dose of piperacillin-tazobactam 2.250 g or placebo was administered i.v. 30 minutes prior to the surgical procedure. Using statistical univariate analysis, the following variables were correlated with a higher infection risk: age >40 years, concomitant disease, WBC <3500, surgical wound size >9cm, use of drainages, non-prophylaxis. Using multivariate analysis, no antibiotic pre-operative prophylaxis, concurrent chronic diseases, especially diabetes (risk 15 times higher), and length of intervention >45 min (risk 6 times higher) were independent predictors of infection. Finally, patients with postoperative infections had a significantly longer hospitalisation. One pre-operative dose of piperacillin-tazobactam 2.250 g is more effective than placebo in preventing postoperative infections in breast surgery and hernia repair.

Surveillance of post-operative infections and management of antibiotic surgical prophylaxis in an Italian region.

The aim of the study was to evaluate the incidence of post-surgical infections and to assess management of antibiotic surgical prophylaxis. The survey was carried out by means of a questionnaire in order to obtain diverse information such as demographics, length of pre- and post-operative hospitalization, type of surgery, intervention duration, possible antibiotic prophylaxis and onset of post-surgical infections also monitored by post-discharge ambulatory controls. Four General Surgery and five Obstetrics and Gynecology Departments in Campania (southern Italy) participated in the study, which was carried out from December 2001-January 2002. Overall, 410 questionnaires were collected, referring to as many patients; antibiotic prophylaxis was performed in 385 (93.9%) patients. Antibiotic prophylaxis was generally managed not according to the general principles suggested by the international guidelines either for timing, for its duration or for the route of administration. Substantial differences were also noted in patient selection and antibiotic choice. Surgical site infections were recorded in 0.9% of patients undergoing clean surgery and in 3.6% of patients undergoing clean-contaminated surgery. Distant infections occurred in 1.5% in clean-contaminated surgery. The results of the present study suggest the need for continuous and accurate monitoring of post-surgical infections and the need to adopt appropriate guidelines to improve the management of surgical prophylaxis.

[The role of mycoses in intrabdominal infections] / Ruolo delle micosi nelle infezioni intraddominali.

In the last few years, there has been a continuous, marked increase in serious mycotic infections, with a high incidence of morbidity and mortality especially among patients undergoing surgery in Intensive Therapy Units. Many risk factors are associated with the development of mycotic infections, amongst which the following may be highlighted: immunosuppression, protracted antibiotic treatment, long NPT, serious trauma, central venous catheterization and, in critical patients, a high APACHE II score. Mycotic peritonitis, an increasingly rare complication found in patients undergoing peritoneal dialysis, seems to be linked to gastric or duodenal perforations treated late (> 24 h) or to secondary, chiefly post-operative peritonitis, in the case of anastomotic dehiscences or fistules, and more generally in surgical patients in unstable conditions, i.e. those with severe acute pancreatitis and cirrhotic imbalances. In the absence of clear clinical signs of mycotic infection, diagnosis is based on the positivity of the culture test carried out in all explorable sites (expectorate, urine, blood, drainage, ascites, intrabdominal sampling), while positivity of haemoculture alone is a real dilemma for the clinician as it may be the result of transitory fungemia or a widespread infection. As yet, there is no reliable diagnostic test, though histopathology, the general signs of sepsis and positive culture in normally sterile sites are used to provide clear indications. Until recently, most patients with intrabdominal infections were not treated with general antimycotics, both because of the relatively low probability of developing a systemic infection and the feared toxicity of amphotericine B. Nowadays, this wait-and-see approach has been discarded, such that high-risk patients are recommended early empirical antimycotic treatment or even prophylaxis. The choice of antimycotic agent, dosage and duration of therapy depends on the aetiologic agent isolated, on the source of infection, renal functionality and associated pathologies. In conclusion, while the incidence of serious mycotic infection has sharply increased, an appropriate therapeutic strategy has not yet been definitively identified, due both to the lack of numerically significant clinical studies and especially the extreme variability and complexity of patients to be treated.

[Central venous catheter - related infections] / Le infezioni da catetere venoso centrale.

Central venous catheters are essential in complex medical and surgical interventions. It is estimated that 200,000 nosocomial bloodstream infections occur each year; 90% of these infections are related to the use of central venous catheters with increased morbidity and mortality, prolonged hospitalization and intensive unit stay, and greater hospital cost. The cause of the increased incidence of bacteremia and intravascular catheter infections is multifactorial and a source of ongoing debate. The skin, parenteral nutritional mixtures or hematogenous seeding accounted for 70% of the catheter-related bloodstream infections (CBI); the remaining 30% were traced to the hub. The three most common types of organisms causing CBI are coagulase negative staphylococci (usually S. epidermidis), S. aureus, and Candida spp. More rarely, gram-negative bacilli (Pseudomonas spp, Acinetobacter spp), enteric organisms and enterococci are implicated. Treatment includes catheter withdrawal and appropriate antibiotic coverage. For patients requiring only short-term access, the most effective approach is catheter removal, administration of parenteral antibiotics and replacement of the catheter at a different site. However, critically ill patients in hemodynamic monitoring or in TPN or chemotherapy require continuous central venous access, and the approach is to change the potentially infected line over guidewire, intravenous antibiotics and "catheter antibiotic lock" for 24 hours. If a patient's clinical course fails to improve after 28-48 hours of antimicrobial therapy, the catheter should be removed and replaced at a new site.

[Microbiological survey in an Intensive Care Unit] / Indagine microbiologica in un reparto di Rianimazione e Terapia Intensiva.

An epidemiological survey on 417 sample from ICU patients, was carried out from January '97 to December 98 to verify the epidemiology of bacteria responsible for nosocomial infections and to monitor the susceptibility patterns to antimicrobial drugs during this period. Microbiological cultures were positive in 47.7% of the samples. P. aeruginosa was the most frequent pathogen, followed by Staphylococcus aureus, Candida spp, coagulase-negative staphylococci, E.coli, with a clear prevalence of Gram-negative over Gram-positive isolates. The evaluation of the antibiotic susceptibility profile of this bacterial pathogens suggests the importance of a costant epidemiological surveillance in ICU.

[Surgical strategies in severe abdominal infections] / Strategia chirurgica nelle infezioni addominali gravi.

Initial treatment of peritonitis is largely standardised (elimination source of infection, debridement and intraoperative lavage) but a major problem is the management policy of patients who are at high risk of further infective complications after the initial operation. Existing prognostic scores based on physiological variables, age and chronic disease (APACHE II), and scores that include intraoperative information about the infection (MPI) unfortunately do not seem to be useful in identifying these patients. Management of severe intra-abdominal infections is founded on three main principles: 1) supportive care of patient, 2 timely and appropriate antimicrobial therapy and 3) an operative treatment to aim at control the source of infection (evacuate pus, treat abdominal compartment syndrome) and prevent or treat persistant and recurrent infections. In the patients with severe intrabdominal infection there is a great variance in surgical strategies but four may be distingued: continous postoperative peritoneal lavage, relaparotomy on demand ("wait and see" policy), open drainage (laparostomy) and planned relaparotomy. The continous postoperative peritoneal lavage and relaparotomy on demand do not seem to prevent residual o recurrent intrabdominal infections and are associated with a high mortality. The planned relaparotomy seem to decrease the rate of residual peritoneal infection but has a high complication rate. It may be concluded that the ideal operative approach for patients with severe intra-abdominal infection has not been established yet. However, these techniques to be beneficial must be performed in well-selected patients and performed by a team of dedicated surgeons.

[Preoperative radiotherapy in locally advanced rectal cancer: risks and complications?]. / La radioterapia preoperatoria nel cancro rettale localmente avanzato: rischi e complicanze?

Adjuvant radiotherapy in advanced rectal cancer is currently considered of interest: preoperative radiotherapy in particular seems to provide better results. However, doubts in its use arise from fear of technical difficulties at surgery and increase of complications. In Authors' opinion, though, preoperative radiotherapy associated with perineal omentoplasty represents a real progress in the management of rectal cancer. Preliminary experience supports this feeling.