Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD).

PURPOSE: Pylorus-preserving pancreatoduodenectomy (PPPD) has been the gold standard for pancreatic head lesion resection for several years. Some studies have noted that it involves more delayed gastric emptying (DGE) than classical Whipple (i.e., pancreatoduodenectomy with antrectomy). Our working hypothesis was that the classical Whipple has a lower incidence of DGE. We aimed to compare the incidence of DGE among pancreatoduodenectomy techniques. METHODS: This pragmatic, randomized, open-label, single-center clinical trial involved patients who underwent classical Whipple (study group) or PPPD (control group). Gastric emptying was clinically evaluated using scintigraphy. DGE was defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria. The secondary endpoints were postoperative morbidity, length of hospital stay, anthropometric measurements, and nutritional status. RESULTS: A total of 84 patients were randomized (42 per group). DGE incidence was 50% (20/40, 95% confidence interval (95% CI): 35-65%) in the study group and 62% (24/39, 95% CI: 46-75%) in the control group (p = 0.260). No differences were observed between both groups regarding postoperative morbidity or length of hospital stay. Anthropometric measurements at 6 months post-surgery: triceps fold measurements were 12 mm and 16 mm (p = 0.021). At 5 weeks post-surgery, triceps fold measurements were 13 mm and 16 mm (p = 0.020) and upper arm circumferences were 26 cm and 28 cm (p = 0.030). No significant differences were observed in nutritional status. CONCLUSION: DGE incidence and severity did not differ between classical Whipple and PPPD. Some anthropometric measurements may indicate a better recovery with PPPD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03984734.

Primary total hip arthroplasty with a fully porous-coated uncemented stem: up to twenty-eight years. Retrospective cohort study.

PURPOSE: The use of cementless prosthesis has increased in the last 30 years with the aim of improving the long-term results of total hip arthroplasties in young and active patients. Encouraging results have recently been reported for cementless titanium and cobalt chromium stems. However, there are few studies with long-term follow-up, and the majority have analysed several models of uncemented stems due to their modifications over the years. Therefore, the aim was to assess the long-term survival rate of the Mittelmeier Mark III or Autophor 900-S stem. METHODS: A retrospective cohort study of both gender patients under 70 years old with at least one implanted Mittelmeier Mark III uncemented stem was performed. Survival rate was defined as the proportion of stems that did not need a surgical revision from any cause. Clinical status was evaluated using the Merle d'Aubigne scale modified by Matta (excellent/good/fair/poor). RESULTS: Between 1990 and 1999, 73 stems were implanted. The mean (SD) age at surgical time was 49.3 (9.9) years, and the median (range) of follow-up was 22 (1-28) years. The overall survival rate was 93% (68/73, 95%CI: 85-97%). The stem revisions were due to stem breakage (n = 2), to aseptic loosening (n = 2) and to septic loosening (n = 1). Clinical results were: excellent 84%, good 15% and fair 1.5%. CONCLUSIONS: The Mittelmeier Mark III stem had an excellent survival rate with a stable long-term fixation and excellent clinical outcomes.

Analysis of outcomes of emergency general and gastrointestinal surgery during the COVID-19 pandemic.

BACKGROUND: Few surgical studies have provided adjusted comparative postoperative outcome data among contemporary patients with and without COVID-19 infection and patients treated before the pandemic. The aim of this study was to determine the impact of performing emergency surgery in patients with concomitant COVID-19 infection. METHODS: Patients who underwent emergency general and gastrointestinal surgery from March to June 2020, and from March to June 2019 in 25 Spanish hospitals were included in a retrospective study (COVID-CIR). The main outcome was 30-day mortality. Secondary outcomes included postoperative complications and failure to rescue (mortality among patients who developed complications). Propensity score-matched comparisons were performed between patients who were positive and those who were negative for COVID-19; and between COVID-19-negative cohorts before and during the pandemic. RESULTS: Some 5307 patients were included in the study (183 COVID-19-positive and 2132 COVID-19-negative during pandemic; 2992 treated before pandemic). During the pandemic, patients with COVID-19 infection had greater 30-day mortality than those without (12.6 versus 4.6 per cent), but this difference was not statistically significant after propensity score matching (odds ratio (OR) 1.58, 95 per cent c.i. 0.88 to 2.74). Those positive for COVID-19 had more complications (41.5 versus 23.9 per cent; OR 1.61, 1.11 to 2.33) and a higher likelihood of failure to rescue (30.3 versus 19.3 per cent; OR 1.10, 0.57 to 2.12). Patients who were negative for COVID-19 during the pandemic had similar rates of 30-day mortality (4.6 versus 3.2 per cent; OR 1.35, 0.98 to 1.86) and complications (23.9 versus 25.2 per cent; OR 0.89, 0.77 to 1.02), but a greater likelihood of failure to rescue (19.3 versus 12.9 per cent; OR 1.56, 95 per cent 1.10 to 2.19) than prepandemic controls. CONCLUSION: Patients with COVID-19 infection undergoing emergency general and gastrointestinal surgery had worse postoperative outcomes than contemporary patients without COVID-19. COVID-19-negative patients operated on during the COVID-19 pandemic had a likelihood of greater failure-to-rescue than prepandemic controls.

Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol.

INTRODUCTION: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. METHODS: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature ≤37.5 °C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours. DISCUSSION: Methylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries. TRIAL REGISTRATION NUMBER: NCT04341038 / EudraCT: 2020-001445-39.

Efficacy of extended infusion of ß-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE).

BACKGROUND: Febrile neutropaenia (FN) is a very common complication in patients with haematological malignancies and is associated with considerable morbidity and mortality. Broad-spectrum antipseudomonal ß-lactam antibiotics (BLA) are routinely used for the treatment of cancer patients with FN. However, the clinical efficacy of BLA may be diminished in these patients because they present with pathophysiological variations that compromise the pharmacokinetic (PK) parameters of these antibiotics. Optimised administration of BLA in prolonged infusions has demonstrated better clinical outcomes in critically ill patients. However, there is a paucity of data on the usefulness of this strategy in patients with FN. The aim of this study is to test the hypothesis that the administration of BLA would be clinically more effective by extended infusion (EI) than by intermittent infusion (II) in haematological patients with FN. METHODS: A randomised, multicentre, open-label, superiority clinical trial will be performed. Patients with haematological malignancies undergoing chemotherapy or haematopoietic stem-cell transplant and who have FN and receive empirical antibiotic therapy with cefepime, piperacillin-tazobactam or meropenem will be randomised (1:1) to receive the antibiotic by EI (during half the time of the dosing interval) in the study group, or by II (30 min) in the control group. The primary endpoint will be clinical efficacy, defined as defervescence without modifying the antibiotic treatment administered within the first 5 days of therapy. The primary endpoint will be analysed in the intention-to-treat population. The secondary endpoints will be pharmacokinetic/pharmacodynamic (PK/PD) target achievement, bacteraemia clearance, decrease in C-reactive protein, overall (30-day) case-fatality rate, adverse events and development of a population PK model of the BLA studied. DISCUSSION: Data on the usefulness of BLA administration in patients with FN are scant. Only three clinical studies addressing this issue have been published thus far, with contradictory results. Moreover, these studies had some methodological flaws that limit the interpretation of their findings. If this randomised, multicentre, phase IV, open-label, superiority clinical trial validates the hypothesis that the administration of BLA is clinically more effective by EI than by II in haematological patients with FN, then the daily routine management of these high-risk patients could be changed to improve their outcomes. TRIAL REGISTRATION: European Clinical Trials Database: EudraCT 2018-001476-37. ClinicalTrials.gov, ID: NCT04233996.

Impact on clinical practice of the preoperative screening of Covid-19 infection in surgical oncological patients. Prospective cohort study.

BACKGROUND: In the oncological patient, an COVID-19-Infection, whether symptomatic or asymptomatic, a surgical procedure may carry a higher postoperative morbidity and mortality. The aim of this study was to describe the impact on clinical practice of sequential preoperative screening for COVID-19-infection in deciding whether to proceed or postpone surgery. METHODS: Prospective, cohort study, based on consecutive patients' candidates for an oncological surgical intervention. Sequential preoperative screening for COVID-19-infection: two-time medical history (telematic and face-to-face), PCR and chest CT, 48 h before of surgical intervention. COVID-19-infection was considered positive if the patient had a suggestive medical history and/or PCR-positive and/or CT of pneumonia. RESULTS: Between April 15th and May 4th, 2020, 179 patients were studied, 97 were male (54%), mean (sd) age 66.7 (13,6). Sequential preoperative screening was performed within 48 h before to surgical intervention. The prevalence of preoperative COVID-19-infection was 4.5%, 95%CI:2.3-8.6% (8 patients). Of the operated patients (171), all had a negative medical history, PCR and chest CT. The complications was 14.8% (I-II) and 2.5% (III-IV). There was no mortality. The hospital stay was 3.1 (sd 2.7) days.In the 8 patients with COVID-19-infection, the medical history was suggestive in all of them, 7 presented PCR-positive and 5 had a chest CT suggestive of pneumonia. The surgical intervention was postponed between 15 and 21 days. CONCLUSION: Preoperative screening for COVID-19-infection using medical history and PCR helped the surgeon to decide whether to go ahead or postpone surgery in oncological patients. The chest CT may be useful in unclear cases.

[Informed consent for anaesthesia: Presential or non-presential information?] / Consentimiento informado de anestesia: ¿información presencial o no presencial?

INTRODUCTION: The anaesthesia informed consent (AIC) is a process of communication between a clinician and a patient that results in the patient agreeing to undergo a specific anaesthetic procedure after understanding all the information needed to make a free, voluntary and conscious decision. This information is traditionally given during a face-to-face pre-operative visit. OBJECTIVE: To evaluate patient perceptions when they receive the information about AIC, face-to-face or by phone. PATIENTS AND METHODS: A single centre, randomised, double-blind, parallel-group pilot clinical trial was conducted on patients > 18 years of age undergoing major ambulatory surgery procedures with a surgical complexity that did not require a face-to-face pre-operative visit. Patients were randomly assigned to be informed by telephone (experimental group) or in a face- to-face visit (control group). Fifteen days after the surgery a questionnaire was used to gather patient perceptions in understanding the anaesthetic procedure and risks, autonomy (to ask for explanations), as well as and satisfaction. RESULTS: Of the 160 patients that gave their consent, 142 were interviewed: 70 from the experimental group and 72 from the control group. Both groups were comparable in age, gender, anaesthetic risk, and surgical complexity. The percentage of patients that understood the information provided on the anaesthetic technique was 71% and 81%, respectively (P=.429); on its risks: 67% and 69% (P=.951); autonomy: 56% and 74% (P=.036) and satisfaction rate: 46% and 46% (P=.835). CONCLUSION: There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction. Nevertheless, almost half of them did not remember to have been given the possibility to clear-up doubts.

Clinical results of infrared coagulation as a treatment of high-grade anal dysplasia: a systematic review.

BACKGROUND: Anal intraepithelial neoplasia (AIN) (or low/high grade squamous intraepithelial neoplasia (L/HSIL)) is the precursor of anal of early invasive anal cancer. Different treatment options for local ablation of localized lesions have been reported. The aim of this study was to analyze the clinical efficacy and safety of infrared coagulation for the treatment of anal dysplasia. METHODS: A search of the literature was performed in 2019 using PubMed and Cochrane to identify all eligible trials published reporting data on the treatment of anal dysplasia with infrared coagulation. The percentage of squamous cell carcinoma of the the anus that developed in the follow-up and results on major complications after treatment were the primary outcomes. RESULTS: Twenty-four articles were identified from which 6 were selected with a total of 360 patients included, with a median age of 41.8 years. Three studies were prospective and 3 retrospective, only one was a randomized trial. All articles included males, 4 articles included HIV-positive women and only one article included non HIV infected males. No patient developed major complications after infrared coagulation therapy. Pain was the most common symptom found after the procedure in the different series and mild bleeding that did not require transfusion was the most common complication occurring in 4 to 78% of patients. Median follow-up was between 4.7 and 69 months. No patient developed squamous cell carcinoma after infrared treatment. Recurrent HSIL varied from 10 to 38%. Two studies reported results from follow-up of untreated patients showing that between 72 and 93% of them had persistent HSIL at last follow-up and 4.8% developed squamous cell carcinoma. CONCLUSIONS: Infrared coagulation is a safe and effective method for ablation of high-grade anal dysplasia that could help prevent anal cancer. Continued surveillance is recommended due to the risk of recurrence.

Early detection of HIV infection and of asymptomatic sexually transmitted infections among men who have sex with men.

OBJECTIVE: To provide data on incidence of early diagnosis of HIV infections and define prevalence and incidence of asymptomatic sexually transmitted infections (STI) in men who have sex with men (MSM). METHODS: We assessed a prospective cohort study of HIV-uninfected MSM at high risk for HIV infection. Participants were selected through a risk-assessment questionnaire, and they were screened for HIV infection (quarterly) and for other STI (yearly): syphilis, and hepatitis A, B and C (serology); Chlamydia trachomatis and Neisseria gonorrhoeae in penis and rectum; and human papillomavirus in anus and mouth (PCR). RESULTS: Between November 2009 and October 2012, a total of 258 HIV-uninfected MSM at high risk for HIV infection were included and followed up for a median of 2 years (interquartile range 1.4, 2.5). Nineteen acute HIV infections were diagnosed (incidence, 3.9 per 100 person-years). Prevalence of STI at baseline was follows: syphilis 8.4% (95% confidence interval (CI) 5.4-12.7); hepatitis C virus (HCV) 2.0% (95% CI 0.7-4.8); C. trachomatis in penis 3.2% (95% CI 1.5-6.5) and in rectum 6.5% (95% CI 3.9-10.5); N. gonorrhoeae in penis 2.0% (95% CI 0.8-5.0) and in rectum 6.1% (95% CI 3.6-10.1); human papillomavirus in anal canal 75.7% (95% CI 68.8-81.5) and in mouth 3.8% (95% CI 1.8-7.7). CONCLUSIONS: The implementation of the Check-Ear Project in a MSM community centre allowed for the identification of early HIV infections and asymptomatic STI among MSM. The high incidence of HIV infections and the high prevalence of STI strongly support the recommendation of periodic screenings among sexually active MSM.

Reliability and accuracy of quantitative sensory testing for oxaliplatin-induced neurotoxicity.

OBJECTIVES: Thermal quantitative sensory testing (QST) is a non-invasive procedure helpful in the assessment of the function of small Aδ and C nerve sensory fibres. Oxaliplatin (OXA) is an effective chemotherapeutic agent, but is frequently associated with neurotoxic dose-limiting side effects. This controlled clinical trial evaluated the reliability and accuracy of thermal QST for assessing the OXA-induced acute neuropathic syndrome, whose clinical hallmark is cold-triggered painful paraesthesia. MATERIALS & METHODS: A testing protocol with the Thermal Sensory Analyzer (Medoc) was carried out in 20 colorectal cancer patients during the initial four cycles of OXA-based chemotherapy and in 20 age- and sex-matched healthy volunteers. Testing was carried out on the hands and included the determination of thermal detection and pain thresholds and the intensity of pain evoked by cold stimuli. Calculations were made of: coefficients of test-retest and inter-rater reliability, indices of responsiveness and parameters that quantify diagnostic accuracy. RESULTS: Thermal thresholds showed moderate to good reliability (ρ ≥ 0.383), but were not consistently responsive to the effects of chemotherapy (cold pain thresholds decreased in both groups, although almost twice in patients compared to healthy volunteers). Conversely, the intensity of pain evoked by suprathreshold cold stimuli was reliable (ρ ≥ 0.822), responsive (detected changes over time) and discriminated between patients and healthy volunteers (area under the ROC curve = 0.700). CONCLUSIONS: The procedure was reliable and accurate to evaluate cold hyperalgesia resulting from OXA administration. The data provided may be used to define efficacy endpoints for future clinical trials of therapies for OXA-induced neuropathies and calculate appropriate sample sizes.

Utilidad de un cuestionario autoadministrado multidimensional para la gestión de una unidad clínica de tratamiento de dolor / Usefulness of a multidimensional self-administered questionnaire for the clinical management of a pain treatment unit

Objective. To study the feasibility of a multidimensional self-administered questionnaire before the patient is seen at the first visit in a clinical Pain Treatment Unit (PTU) of a tertiary hospital, and its impact on the management of patients in the first visit. Patients and methods. Cross-sectional study. Self-administered questionnaire that gathered: socio-demographic data, medical history of pain, pain perception (intensity and characteristics), comorbidity of pain and patient expectations of analgesic treatment ("What do you expect from our treatment? If we cannot resolve your pain, what level of pain would you be willing to live with?). A descriptive analysis was performed. Results. A total of 293 consecutive patients (31% men, 69% women), mean age (SD) 62 (16) years-old, were included in 2011. All patients completed and returned the questionnaire before the first visit to the PTU. The questionnaire was completed fully and correctly by 80% (234, 95% CI: 75-84) of the patients, and the rest completed the questionnaire with some points unanswered. About 24% (70/293, 95% CI: 19-29) of the patients should not have been referred to the PTU [20% were not attended]. A small percentage (9%,26/293, 95% CI: 6-13) were evaluated as «urgent’» and visited over the following 7 days, with 19% (56/293, 95%CI: 15-24) being «preferential» (visited before 15 days) and 52% (152/293, 95% CI: 46-58) as «non-urgent/non-preferential» (visited before 60 days). Almost one third (30%, 87/293, 95% CI: 25-35) did not need a second visit to the PTU. Patient expectations: 21% expected complete pain relief and 64% would accept a lower pain intensity score of 4. Conclusion. The use of a multidimensional self-administered questionnaire before the first visit to a clinical Pain Treatment Unit of a tertiary hospital was a practicable and useful tool for the management of patients on the first visit. Likewise, the questionnaire provided information on the patient's perception of pain and the expectations concerning the analgesic treatment (AU)

Objetivo. Estudiar la factibilidad de un cuestionario autoadministrado multidimensional antes de que el paciente sea atendido en primera visita en la unidad de tratamiento del dolor (UTD) de un hospital terciario, y su impacto en la gestión de pacientes en la primera visita. Pacientes y métodos. Estudio transversal. Cuestionario autoadministrado: características sociodemográficas, historia clínica del dolor, percepción del dolor (intensidad y sus características), comorbilidad del dolor y expectativas del paciente al tratamiento analgésico («¿qué es lo que usted espera de nuestro tratamiento?», si no podemos resolver su dolor «¿qué nivel de dolor aceptaría?»). Se realizó un análisis descriptivo. Resultados. Durante el año 2011 fueron incluidos 293 pacientes consecutivos (31% hombres, 69% mujeres; edad media 62 ± 16 años). Todos los pacientes cumplimentaron y entregaron el cuestionario antes de la primera visita en la UTD. El 80% (234/293, IC 95%: 75-84) de pacientes lo cumplimentaron completa y correctamente; el resto lo aportaron con algunos puntos sin contestar. El 24% (70/293, IC 95%: 19-29) de pacientes no deberían haber sido remitidos a la UTD (un 20% no llegaron a ser visitados en la UTD). Un 9% (26/293, IC 95%: 6-13) de las primeras visitas se consideraron «urgentes» (y estos pacientes fueron visitados en la UTD antes de 7 días), mientras que el 19% (56/293, IC 95%: 15-24) se calificaron de «preferentes» (atendidos antes de 15 días) y el 52% (152/293, IC 95%: 46-58) de «no-urgentes/no-preferentes» (atendidos antes de 60 días). Un 30% (87/293, IC 95%: 25-35) de los casos no necesitaron una segunda visita en la UTD. Respecto a las expectativas del paciente cabe reseñar que el 21% esperaban un alivio completo de su dolor, y el 64% aceptarían continuar con un dolor de intensidad < 4. Conclusión. El uso del cuestionario autoadministrado multidimensional antes de la primera visita en una Unidad Clínica del Tratamiento del Dolor de un hospital terciario fue practicable y útil como instrumento para la gestión de los pacientes en primera visita. Asimismo, proporcionó información sobre la percepción del dolor y las expectativas del paciente referente al tratamiento analgésico (AU)

[Usefulness of a multidimensional self-administered questionnaire for the clinical management of a pain treatment unit]. / Utilidad de un cuestionario autoadministrado multidimensional para la gestión de una unidad clínica de tratamiento de dolor.

OBJECTIVE: To study the feasibility of a multidimensional self-administered questionnaire before the patient is seen at the first visit in a clinical Pain Treatment Unit (PTU) of a tertiary hospital, and its impact on the management of patients in the first visit. PATIENTS AND METHODS: Cross-sectional study. Self-administered questionnaire that gathered: socio-demographic data, medical history of pain, pain perception (intensity and characteristics), comorbidity of pain and patient expectations of analgesic treatment ("What do you expect from our treatment? If we cannot resolve your pain, what level of pain would you be willing to live with?). A descriptive analysis was performed. RESULTS: A total of 293 consecutive patients (31% men, 69% women), mean age (SD) 62 (16) years-old, were included in 2011. All patients completed and returned the questionnaire before the first visit to the PTU. The questionnaire was completed fully and correctly by 80% (234, 95% CI: 75-84) of the patients, and the rest completed the questionnaire with some points unanswered. About 24% (70/293, 95% CI: 19-29) of the patients should not have been referred to the PTU [20% were not attended]. A small percentage (9%,26/293, 95% CI: 6-13) were evaluated as «urgent'¼ and visited over the following 7 days, with 19% (56/293, 95%CI: 15-24) being «preferential¼ (visited before 15 days) and 52% (152/293, 95% CI: 46-58) as «non-urgent/non-preferential¼ (visited before 60 days). Almost one third (30%, 87/293, 95% CI: 25-35) did not need a second visit to the PTU. Patient expectations: 21% expected complete pain relief and 64% would accept a lower pain intensity score of 4. CONCLUSION: The use of a multidimensional self-administered questionnaire before the first visit to a clinical Pain Treatment Unit of a tertiary hospital was a practicable and useful tool for the management of patients on the first visit. Likewise, the questionnaire provided information on the patient's perception of pain and the expectations concerning the analgesic treatment.

Oral human papillomavirus type-specific infection in HIV-infected men: a prospective cohort study among men who have sex with men and heterosexual men.

The natural history of type-specific oral infection of human papillomavirus (HPV) was assessed in a cohort of HIV-infected men (538 men who have sex with men (MSM); 195 heterosexuals). Risk factors associated with oral HPV infections were examined. The overall prevalence of HPV was 16%: HPV-16 was the most prevalent type (3.7% MSM; 7.8% heterosexuals). The prevalence of HPV-16 in heterosexuals was associated with CD4 nadir counts <200 cells/µL (ORadjusted = 3.0, 95% CI, 1.4-6.3). The overall incidence of HPV was similar between groups (11%), but the incidence of HPV-16 was higher in heterosexuals (ORadjusted = 3.2, 95% CI, 1.1-9.5). Not only MSM but also HIV-infected heterosexual men are at risk of HPV infection. Regular and careful oral inspection is needed.

Progression of liver fibrosis in HIV/hepatitis C virus-coinfected individuals on antiretroviral therapy with early stages of liver fibrosis at baseline.

OBJECTIVES: The aim of the study was to assess the progression of liver fibrosis in HIV/hepatitis C virus (HCV)-coinfected patients with no or mild-to-moderate fibrosis (stages F0-F2). METHODS: Liver fibrosis was reassessed by transient elastometry (TE) between January 2009 and November 2011 in HIV/HCV-coinfected patients with stage F0-F2 fibrosis in a liver biopsy performed between January 1997 and December 2007. Patients with liver stiffness at the end of follow-up < 7.1 kPa were defined as nonprogressors, and those with values ≥ 9.5 kPa or who died from liver disease were defined as progressors. Cirrhosis was defined as a cut-off of 14.6 kPa. The follow-up period was the time between liver biopsy and TE. Cox regression models adjusted for age, gender and liver fibrosis stage at baseline were applied. RESULTS: The median follow-up time was 7.8 years [interquartile range (IQR) 5.5-10 years]. The study population comprised 162 patients [115 (71%) nonprogressors and 47 (29%) progressors; 19 patients (11.7%) had cirrhosis]. The median time from the diagnosis of HCV infection to the end of follow-up was 20 years (IQR 16.3-23.1 years). Three progressors died from liver disease (1.8%). The variables associated with a lower risk of progression were age ≤ 38 years (hazard ratio (HR) 0.32; 95% confidence interval (CI) 0.16-0.62; P = 0.001], having received interferon (HR 2.18; 95% CI 1.14-4.15; P = 0.017), being hepatitis B virus surface antigen (HBsAg) negative (HR 0.20; 95% CI 0.04-0.92; P = 0.039), and baseline F0-F1 (HR 0.43; 95% CI 0.28-0.86; P = 0.017). CONCLUSIONS: A high proportion of patients with stage F0-F2 fibrosis progress to advanced liver fibrosis. Advanced liver fibrosis must be included in the list of diseases associated with aging. Our results support the recommendation to offer HCV antiviral therapy to HIV/HCV-coinfected patients at early stages of liver fibrosis.

Circumcision and penile human papillomavirus prevalence in human immunodeficiency virus-infected men: heterosexual and men who have sex with men.

Male circumcision is associated with a lower risk of penile human papillomavirus (HPV) infection in human immunodeficiency virus (HIV) uninfected men. Few studies have evaluated the role of male circumcision in penile HPV infection in HIV-infected men. The aim of this cross-sectional study was to examine the association between male circumcision and the prevalence of penile HPV infection among HIV-infected men-both men who have sex with men (MSM) and heterosexual men. Samples from 706 consecutive men included in the CARH-MEN cohort (overall 24% circumcised: 26% of MSM, 18% of heterosexual men) were examined by Multiplex-PCR. In the overall group (all HIV-infected men included), the prevalence of any penile HPV infection was 22% in circumcised men and 27% in uncircumcised men (OR = 1.0, 95% CI 0.6-1.6, adjusted analysis). In the circumcised group the overall prevalence of HPV infection was 22% in MSM and 24% in the heterosexual men, whereas in the uncircumcised group the prevalence was 26% and 28%, respectively. The prevalence of high-risk HPV types tended to be lower in the circumcised MSM (14% vs 21%, OR = 0.6, 95% CI 0.3-1.1, p 0.088), but it was similar in the heterosexual men (18% in circumcised vs 20% in uncircumcised). These results suggest that male circumcision may be associated with a lower prevalence of oncogenic high-risk penile HPV infection in HIV-infected MSM.

Investigación clínica y nivel asistencial de excelencia / Clinical research and level of excellence in health care

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