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1.
Cir Esp ; 101(1): 29-34, 2023 Jan.
Artículo en Español | MEDLINE | ID: mdl-34720121

RESUMEN

Introduction: The SARS-CoV-2 pandemic has affected training opportunities for healthcare professionals partly because face to face courses were cancelled. This study analyzes the results of participation and satisfaction of the AEC Virtual Classroom sessions during the first year. Methods: The AEC Virtual Classroom includes a combined format of weekly Webinar broadcast live that can be viewed on a delayed basis in a virtual platform. In this study, the results in its first year are evaluated considering the number of live participants, the delayed views and the global reach; as well as the results of the satisfaction survey in each of the sessions (0-10). Results: From 16/04/2020 to 15/04/2021, 50 sessions of the Virtual Classroom AEC were held. The average scope of the sessions was 509 ± 288 views with a range between 196 and 149. At the times of highest incidence of cases during the pandemic, a decrease in live participants was observed 275 ± 135 vs. 391 ± 233 (p = 0.032). The mean score on the format was 8.46 ± 0.31/10. The best-scored sessions were those of the subject related to coloproctology with a statistically significant difference in the mean score 8.79 ± 0.42 vs. 8.39 ± 0.27 (p = 0.035). 90% of users considered the sessions useful. 97.2% of respondents believe that the sessions should be maintained after the pandemic. Conclusions: The AEC Virtual Classroom has a very good results in the first year, proving to be a useful surgical teaching tool that will foreseeably survive once the pandemic is over.

2.
Langenbecks Arch Surg ; 407(8): 3671-3679, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36239791

RESUMEN

PURPOSE: Deep endometriosis (DE) is defined by the presence of ectopic endometrial glands, with rectal involvement ranging from 5.3 to 12%. The prevalence of low anterior resection-like syndrome (LARS) in patients with DE, how it affects quality of life (QoL), and its evolution after surgery is unclear. The objective of this study was to assess the gastrointestinal functional outcomes and QoL in patients who underwent surgery for DE. PATIENTS AND METHODS: A prospective study was conducted from 2017 to 2019, recruiting patients who underwent DE surgery with and without rectal resection. Patients completed LARS and SF-36 questionnaires before, at 6 months and at 1 year after surgery. RESULTS: Eighty-two patients were enrolled. Rectal segmental resection was required in 16 (19.5%) patients, shaving in 16 (19.5%) and discoid resection in 8 (9.8%). All 8 domains of the SF-36 questionnaire showed improvement during follow-up, reflecting improved QoL after surgery (p ≤ 0.05) in all patients. Mean LARS scores for patients without rectal surgery were 7.5 ± 10.4 before and 13.7 ± 14.2 1 year after surgery; rectal surgery was 13.6 ± 13.6 and 14.6 ± 13.1, respectively (p = 0.17). No significant differences were found in the rectal surgery patients' postoperative LARS score among the 3 rectal DE surgical techniques (p = 0.97), and the SF-36 scores improved independent of the technique performed. CONCLUSIONS: Patients with DE present a LARS-like syndrome before surgery that does not appear to be negatively affected after rectal surgery, independent of the technique performed. Rectal surgery improves the QoL of patients with DE patients as measured by the SF-36 questionnaire at 1 year of follow-up.


Asunto(s)
Endometriosis , Enfermedades del Recto , Neoplasias del Recto , Femenino , Humanos , Calidad de Vida , Complicaciones Posoperatorias/epidemiología , Endometriosis/cirugía , Estudios Prospectivos , Síndrome , Neoplasias del Recto/cirugía , Resultado del Tratamiento , Enfermedades del Recto/cirugía
3.
Langenbecks Arch Surg ; 406(4): 1181-1188, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33515317

RESUMEN

PURPOSE: As one of the clinical manifestations of inflammatory bowel disease (IBD), perianal fistula disease (PFD) can potentially impact the patient quality of life. The management of PFD employs a multidisciplinary approach which includes antibiotics, biological therapies, immunomodulators, and surgery. We analyzed the outcome and prognostic factors of anal fistula surgery in IBD patients. METHODS: We conducted a retrospective study of IBD patients undergoing elective surgery for anal fistula between January 2015 and December 2018 at our University Department of Surgery. We collated demographic factors, disease activity, imaging (MRI and endoanal ultrasound), surgical interventions, and medical treatment assessing the rate of fistula closure and fecal incontinence, 2 months and 1 year after surgery. RESULTS: Thirty-five IBD patients with anal fistula underwent surgery (28 Crohn's disease, four ulcerative colitis, and three indeterminate colitis). Twenty-seven patients presented with complex fistulas and eight with simple fistulas with 10 patients undergoing single-stage surgery. In 25 patients, a two-stage surgical approach was planned and performed (draining seton plus medical treatment and then second-stage surgery with curative intent). At 1 year of follow-up, the fistula healing rate was 50% for single-stage surgery and 60% for two-stage surgery (P = 0.09). Overall, 19.2% of patients developed postoperative fecal incontinence. A time interval greater than 12 months between surgeries is a favorable prognostic factor for fistula healing with the two-stage approach (P = 0.002). CONCLUSIONS: In our retrospective study, two-stage surgery in IBD patients presenting with complex perianal fistulous disease results in a better medium-term outcome with a longer time interval between surgeries.


Asunto(s)
Colitis , Enfermedad de Crohn , Fístula Rectal , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/cirugía , Humanos , Pronóstico , Calidad de Vida , Fístula Rectal/etiología , Fístula Rectal/cirugía , Estudios Retrospectivos , Resultado del Tratamiento
4.
Rev Esp Enferm Dig ; 113(12): 847, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34315218

RESUMEN

A 34-year-old female with stricturing ileal Crohn´s disease (CD) treated with adalimumab presented with recurrent subocclusive episodes and clinical worsening. First, she received corticosteroids without any clinical improvement.


Asunto(s)
Enfermedad de Crohn , Endometriosis , Enfermedades del Íleon , Adalimumab/uso terapéutico , Adulto , Enfermedad de Crohn/tratamiento farmacológico , Endometriosis/complicaciones , Endometriosis/diagnóstico , Femenino , Humanos , Enfermedades del Íleon/diagnóstico por imagen , Enfermedades del Íleon/etiología , Íleon
5.
J Med Virol ; 87(8): 1397-403, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-25940055

RESUMEN

Currently, screening for anal high-grade squamous intraepithelial lesions (anal HSIL) relies on anal cytology and high-resolution anoscopy. Since this approach has limited sensitivity and specificity for detecting anal HSIL, there is increasing interest in the role of biomarkers for predicting anal HSIL. The aim of this study is to evaluate the diagnostic accuracy of HPV E6/E7-mRNA expression for the detection of anal HSIL in MSM infected with HIV, in comparison to DNA-HR-HPV and anal cytology. This cross-sectional screening study included 101 MSM followed at the HIV-unit of La Paz University Hospital. Intra-anal swabs from patients participating in a screening program including cytology, high-resolution anoscopy and histology were analyzed. HR-HPV-DNA detection was performed by means of the CLART® HPV2 assay (GENOMICA S.A.U., Madrid, Spain). E6/E7-mRNA detection of HR-HPV-types 16, 18, 31, 33, and 45 was performed using the NucliSENS-EasyQ assay (BioMérieux, Marcy lEtoile, France). HR-HPV DNA and HPVE6/E7 mRNA were detected in 82% and 57% of the anal smears respectively. Anal cytology screening was abnormal in 70.3%. For the detection of HSIL sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 71.7%, 55.6%, 57.9%, and 69.8% for E6/E7-mRNA testing, respectively, compared to 100%, 31.5%, 55.4%, and 100% for HR-HPV-DNA testing and to 83%, 40.7%, 54.9%, 73.3% of cytology testing. In comparison with the other tests, HPVE6/E7 mRNA testing yielded a lower clinical sensitivity but a higher clinical specificity and PPV for the detection of anal HSIL in MSM infected with HIV.


Asunto(s)
Detección Precoz del Cáncer/métodos , Proteínas Oncogénicas Virales/biosíntesis , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/diagnóstico , ARN Mensajero/análisis , ARN Viral/análisis , Lesiones Intraepiteliales Escamosas de Cuello Uterino/diagnóstico , Adulto , Anciano , Biomarcadores/análisis , Estudios Transversales , Femenino , Perfilación de la Expresión Génica/métodos , Infecciones por VIH/complicaciones , Homosexualidad Masculina , Humanos , Masculino , Persona de Mediana Edad , Proteínas Oncogénicas Virales/genética , Papillomaviridae/genética , Infecciones por Papillomavirus/virología , Estudios Prospectivos , ARN Mensajero/genética , ARN Viral/genética , Sensibilidad y Especificidad , Lesiones Intraepiteliales Escamosas de Cuello Uterino/virología , Adulto Joven
7.
Cir Esp (Engl Ed) ; 2024 May 25.
Artículo en Inglés | MEDLINE | ID: mdl-38801975

RESUMEN

Classical surgery, also called analog surgery, is transmitted to us by our mentors, whose knowledge has been delegated from generation to generation throughout the history of surgery. Its main limitations are limited surgical precision and dependence on the surgeon's skill to achieve surgical goals. So-called digital surgery incorporates the most advanced technology, with the aim of improving the results of all phases of the surgical process. Robotic platforms are currently considered to be one of the main drivers of the digital transformation of surgery. They bring considerable advances to the digitalization of surgery, including: higher quality visualization, more controlled and stable movements with elimination of tremor, minimized risk of errors, data integration throughout the patient's surgical process, use of various systems for better surgical planning, application of virtual and augmented reality, telementoring, and artificial intelligence.

8.
Updates Surg ; 2024 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-38622316

RESUMEN

The COVID-19 pandemic has led to a change in healthcare models. The aim of this study was to evaluate patient acceptance of telehealth as an alternative to physical consultations, and to identify factors predicting higher satisfaction. This was an observational, cross-sectional, multi-center, international study. All consecutive patients for whom telehealth was used in consultations between April and July 2020 were considered for inclusion. The validated Telehealth Usability Questionnaire (TUQ) was used as a model to measure patient acceptance. Overall, 747 patients were observed, of whom 721 agreed to participate (96·5%). The TUQ showed that 86·9% of patients agreed that telehealth was useful; 85·2% supported the interface quality and 81·4% endorsed the interaction quality. Patients aged > 60 y were less likely to agree with the use of telehealth (p < 0·05). A web-based prediction tool was generated to calculate global satisfaction and to identify patients more likely to feel comfortable with telehealth. Telehealth is feasible and allows consultations that are satisfactory for patients. Technological advancements could ease safe implementation of telehealth into everyday practice. Adequate patient selection can be useful to ensure that the ideal strategy is used for each individual during and after the pandemic.

9.
Ann Coloproctol ; 39(3): 216-222, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35255203

RESUMEN

PURPOSE: The surgical management of deep infiltrative endometriosis (DE) involving the rectum remains a challenge. The objective of this study was to assess the outcomes from a single tertiary center over a decade with an emphasis on the role of a protective loop ileostomy (PI). METHODS: A retrospective review of outcomes for 168 patients managed between 2008 and 2018 is presented including 57 rectal shaves, 23 discoid excisions, and 88 segmental rectal resections. RESULTS: The nodule size (mean±standard deviation) in the segmental resection group was 32.7±11.2 mm, 23.4±10.5 mm for discoid excision, and 18.8±6.0 mm for rectal shaves. A PI was performed in 19 elective cases (11.3%) usually for an ultra-low anastomosis <5 cm from the anal verge. All Clavien-Dindo grade III/IV complications occurred after segmental resections and included 5 anastomotic leaks, 6 rectovaginal fistulas, 2 ureteric fistulas, and 1 ureteric stenosis. Of 26 stomas (15.5%), there were 19 PIs, 3 secondary ileostomies (after complications), and 4 end colostomies. The median time to PI closure was 5.8 months (range, 0.4-16.7 months) in uncomplicated disease compared with 9.2 months (range, 4.7-18.4 months) when initial postoperative complications were recorded (P=0.019). Only 1 patient with a recurrent rectovaginal fistula had a permanent colostomy. CONCLUSION: In patients with DE and rectal involvement a PI is selectively used for low anastomoses and complex pelvic reconstructions. Protective stomas and those used in the definitive management of a major postoperative complication can usually be reversed.

10.
Cir Esp (Engl Ed) ; 101(1): 29-34, 2023 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-35809787

RESUMEN

INTRODUCTION: The SARS-CoV-2 pandemic has affected training opportunities for healthcare professionals partly because face to face courses were cancelled. This study analyzes the results of participation and satisfaction of the AEC Virtual Classroom sessions during the first year. METHODS: The AEC Virtual Classroom includes a combined format of weekly Webinar broadcast live that can be viewed on a delayed basis in a virtual platform. In this study, the results in its first year are evaluated considering the number of live participants, the delayed views and the global reach; as well as the results of the satisfaction survey in each of the sessions (0-10). RESULTS: From 16/04/2020 to 15/04/2021, 50 sessions of the Virtual Classroom AEC were held. The average scope of the sessions was 509 ± 288 views with a range between 196 and 149. At the times of highest incidence of cases during the pandemic, a decrease in live participants was observed 275 ± 135 vs. 391 ± 233 (P = 0.032). The mean score on the format was 8.46 ± 0.31/10. The best-scored sessions were those of the subject related to coloproctology with a statistically significant difference in the mean score 8.79 ± 0.42 vs. 8.39 ± 0.27 (P = 0.035). 90% of users considered the sessions useful. 97.2% of respondents believe that the sessions should be maintained after the pandemic. CONCLUSIONS: The AEC Virtual Classroom has had very good results in the first year, proving to be a useful surgical teaching tool that will foreseeably survive once the pandemic is over.


Asunto(s)
COVID-19 , Pandemias , Humanos , COVID-19/epidemiología , SARS-CoV-2
11.
Cir Esp (Engl Ed) ; 101(6): 435-444, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36565988

RESUMEN

INTRODUCTION: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. METHODS: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. RESULTS: 16 patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic Mucosal Resection (EMR) (6.3%), Endoscopic Submucosal Dissection ESD (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. In no case did rectal perforation or major complications requiring urgent reintervention occur. As for the level of reproducibility, safety, level of satisfaction with the device and evaluation of the blister, the evaluation on a scale of 0-10 (9.43, 9.71, 9.29 and 9.50 respectively). All the investigators have previous experience with transanal devices. CONCLUSIONS: The study demonstrates the efficacy and safety of UNI-VEC® for the treatment of rectal lesions. It will facilitate the implementation of hybrid procedures that seek to solve the limitations of pure endoscopic techniques by allowing the concomitant use of conventional laparoscopic and robotic instrumentation with the flexible endoscope.


Asunto(s)
Laparoscopía , Neoplasias del Recto , Humanos , Estudios Prospectivos , Reproducibilidad de los Resultados , Neoplasias del Recto/cirugía , Neoplasias del Recto/patología , Recto/cirugía , Recto/patología
12.
Cir Esp (Engl Ed) ; 99(10): 707-715, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34764063

RESUMEN

Technology is one of the pillars of surgery in the 21st century and is a key factor in achieving better surgical results. The current surgical process involves not only surgical techniques, but also a very high degree of specialisation and the knowledge and use of techniques and devices from other fields. In Spain, there are no studies published at a national level in this regard. From the Minimally Invasive Surgery and Technological Innovation section of the Spanish Association of Surgeons we have designed a study whose main objective is to evaluate the degree of technological implantation in the specialty of General Surgery in Spain, as well as to analyze the devices available in the different centres of the country. We propose to make a detailed description of the applications of these devices and techniques by areas of interest, pointing out the pathologies and procedures in which this technology is used.


Asunto(s)
Procedimientos Quirúrgicos Mínimamente Invasivos , Tecnología , España
13.
Cir Esp (Engl Ed) ; 2021 Mar 18.
Artículo en Inglés, Español | MEDLINE | ID: mdl-33745719

RESUMEN

Technology is one of the pillars of surgery in the 21st century and is a key factor in achieving better surgical results. The current surgical process involves not only surgical techniques, but also a very high degree of specialisation and the knowledge and use of techniques and devices from other fields. In Spain, there are no studies published at a national level in this regard. From the Minimally Invasive Surgery and Technological Innovation section of the Spanish Association of Surgeons we have designed a study whose main objective is to evaluate the degree of technological implantation in the specialty of General Surgery in Spain, as well as to analyze the devices available in the different centres of the country. We propose to make a detailed description of the applications of these devices and techniques by areas of interest, pointing out the pathologies and procedures in which this technology is used.

14.
Cir Esp (Engl Ed) ; 99(3): 174-182, 2021 Mar.
Artículo en Inglés, Español | MEDLINE | ID: mdl-33341242

RESUMEN

The SARS-CoV-2 (COVID-19) pandemic requires an analysis in the field of oncological surgery, both on the risk of infection, with very relevant clinical consequences, and on the need to generate plans to minimize the impact on possible restrictions on health resources. The AEC is making a proposal for the management of patients with hepatopancreatobiliary (HPB) malignancies in the different pandemic scenarios in order to offer the maximum benefit to patients, minimising the risks of COVID-19 infection, and optimising the healthcare resources available at any time. This requires the coordination of the different treatment options between the departments involved in the management of these patients: medical oncology, radiotherapy oncology, surgery, anaesthesia, radiology, endoscopy department and intensive care. The goal is offer effective treatments, adapted to the available resources, without compromising patients and healthcare professionals safety.


Asunto(s)
COVID-19/prevención & control , Neoplasias del Sistema Digestivo/cirugía , Control de Infecciones/organización & administración , Selección de Paciente , Oncología Quirúrgica/organización & administración , COVID-19/epidemiología , COVID-19/transmisión , Neoplasias del Sistema Digestivo/patología , Humanos
15.
Cir Esp (Engl Ed) ; 98(6): 320-327, 2020.
Artículo en Inglés, Español | MEDLINE | ID: mdl-32336467

RESUMEN

INTRODUCTION: The rapid spread of SARS-CoV-2 infection has led to a radical reorganization of healthcare resources. Surgical Departments need to adapt to this change. METHODS: We performed a prospective descriptive observational study of the incidence of COVID-19 in patients and surgeons of a General Surgical Department in a high prevalence area, between the 1st and 31st of March 2020. RESULTS: Patients: The incidence of SARS-CoV-2 infection in elective surgery patients was 7% (mean age 59.5 years). All survived. Of 36 patients who underwent emergency surgery, two of them were SARS-CoV-2 positive and one was clinically highly suspicious of COVID-19 (11.1%). All three patients died of respiratory failure (mean age 81 years). Surgeons: There were a total of 12 confirmed SARS-CoV-2+ cases among the surgical department staff (24.4%) (8 out of 34 consultants and 4 out of 15 residents). Healthcare activity: The average number of daily emergency surgical interventions declined from 3.6 in February to 1.16 in March. 42% of the patients who underwent emergency surgery had peritonitis upon presentation. CONCLUSIONS: The fast pace of COVID-19 pandemia should alert surgical departments of the need of adopting early measures to ensure the safety of patients and staff.


Asunto(s)
Infecciones por Coronavirus/epidemiología , Procedimientos Quirúrgicos Electivos/estadística & datos numéricos , Neumonía Viral/epidemiología , Cirujanos/estadística & datos numéricos , Servicio de Cirugía en Hospital , Procedimientos Quirúrgicos Operativos/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , COVID-19 , Urgencias Médicas , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pandemias , Estudios Prospectivos , España/epidemiología , Centros de Atención Terciaria
16.
Cir Esp (Engl Ed) ; 98(5): 251-259, 2020 May.
Artículo en Inglés, Español | MEDLINE | ID: mdl-32252979

RESUMEN

Due to the current pandemic of respiratory disease known as coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus, many patients with confirmed or suspected COVID-19 infection will require elective surgery, surgery that cannot be postponed, or emergency surgical treatment. In these situations, special measures need to be adopted in order to minimize the possibility of transmission between patients, exposure of healthcare personnel and the development of postoperative complications. This document explains the main principles to consider when managing confirmed or suspected COVID-19 patients during evaluation as well as when surgical treatment is required.


Asunto(s)
Infecciones por Coronavirus/transmisión , Transmisión de Enfermedad Infecciosa/prevención & control , Control de Infecciones/métodos , Pandemias , Neumonía Viral/transmisión , Procedimientos Quirúrgicos Operativos/métodos , COVID-19 , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/prevención & control , Humanos , Pandemias/prevención & control , Neumonía Viral/complicaciones , Neumonía Viral/prevención & control
17.
Cir Esp (Engl Ed) ; 97(1): 11-19, 2019 Jan.
Artículo en Inglés, Español | MEDLINE | ID: mdl-30093099

RESUMEN

INTRODUCTION: The use and utility of social media (SM) among Spanish general surgeons is unknown. METHODS: Between October and December 2017 an online survey was carried out to the members of the Spanish Association of Surgeons, in which data on the profile of use and opinion on the usefulness of SM were collected. RESULTS: 360 valid responses were obtained, 310 from surgeons who had an active SM profile. The most popular networks were: Facebook (86%), LinkedIn (61,6%), YouTube (60,6%) and Twitter (54,2%). LinkedIn and Twitter stood out as the most used SM for professional purposes. Surgeons with a SM profile were younger (42.4±11 years versus 51.6±8 years; P<.001). Gender did not show influence on presence in SM. The majority of respondents have profiles in more than one network (3.6±1 accounts) and 73.5% reported daily access to them; 19.7% of the surgery departments to which the respondents belong have a SM account. Among SM utilities in the professional field, training activities (87%) and connectivity among professionals (84%) were the most outstanding; 14.1% of respondents use SM to interact with patients. CONCLUSIONS: SM is useful as a tool for the acquisition, updating and dissemination of scientific knowledge, also proving valuable as a new form of interaction among surgeons. Other issues such as privacy or surgeon-patient relationship represent a barrier to its use.


Asunto(s)
Cirugía General , Red Social , Cirujanos/estadística & datos numéricos , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Autoinforme , Sociedades Médicas , España
18.
AIDS ; 30(1): 75-82, 2016 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-26731755

RESUMEN

OBJECTIVE: To evaluate the efficacy of 1% topical cidofovir cream for the treatment of anal high-grade squamous intraepithelial lesions (HSILs) in HIV-infected individuals. DESIGN: Single-arm, open-label, pilot clinical trial. METHODS: The study medication was applied intraanally three times per week for 4 weeks. Lesions were assessed with high-resolution anoscopy and biopsy at weeks 12 and 24. The primary endpoint was complete remission (CR) at week 12, defined as clinical and histological remission. We also evaluated partial remission defined as regression to low-grade squamous intraepithelial lesion. RESULTS: We included 17 HIV-infected patients with intraanal HSIL. Median (interquartile range) age was 36 years (28-41), median (interquartile range) CD4 cell count was 545 cells/µl (358-630), and viral load was less than 50  copies/ml in 93.7%. Two patients were lost to follow-up, one of them did not apply treatment. At 12 weeks, in the intention-to-treat population, 10 out of 16 patients [62.5%; 95% confidence interval (CI), 38.2-85.7%] had achieved CR. At 24 weeks, seven of the 10 patients (70%; 95% CI, 47-93%) remained in CR, but two out of 10 patients (20%; 95% CI, 0-40%) presented HSIL. One patient did not attend the visit at 24 weeks. Three patients with persistent HSIL at 12 weeks improved at 24 weeks (partial response in one and CR in two). The mean number of human papillomavirus genotypes decreased from 5.2 to 2.7 at 12 weeks (P = 0.002). Local adverse effects were frequent (81%), although there were no discontinuations because of adverse events. CONCLUSION: One percent topical cidofovir could be an appropriate alternative therapy in HIV-infected patients with anal HSIL. CLINICAL TRIAL: gov unique identifier: NCT01946009.


Asunto(s)
Antivirales/administración & dosificación , Neoplasias del Ano/tratamiento farmacológico , Carcinoma in Situ/tratamiento farmacológico , Citosina/análogos & derivados , Infecciones por VIH/complicaciones , Organofosfonatos/administración & dosificación , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/tratamiento farmacológico , Administración Tópica , Adulto , Biopsia , Cidofovir , Citosina/administración & dosificación , Humanos , Masculino , Proyectos Piloto , Resultado del Tratamiento
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