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1.
Hernia ; 27(3): 657-664, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36966221

RESUMEN

PURPOSE: Short-term results have been reported regarding parastomal hernia (PH) prevention with a permanent mesh. Long-term results are scarce. The objective was to assess the long-term PH occurrence after a prophylactic synthetic non-absorbable mesh. METHODS: Long-term data of three randomized controlled trials (RCTs) were collected. The primary outcome was the detection of PH based exclusively on a radiological diagnosis by computed tomography (CT) performed during the long-term follow-up. The Kaplan-Meier method was used for the comparison of time to diagnosis of PH according to the presence of mesh vs. no-mesh and the technique of mesh insertion: open retromuscular, laparoscopic keyhole, and laparoscopic modified Sugarbaker. RESULTS: We studied 121 patients (87 men, median age 70 years), 82 (67.8%) of which developed a PH. The median overall length of follow-up was 48.5 months [interquartile range (IQR) 14.4-104.9], with a median time until PH diagnosis of 17.7 months (IQR 9.3-49.0). The survival analysis did not show significant differences in the time to development of a PH according to the presence or absence of a prophylactic mesh neither in the overall study population (log-rank, P = 0.094) nor in the groups of each technique of mesh insertion, although according to the surgical technique, a higher reduction in the appearance of PH for the open retromuscular technique was found (log-rank, P = 0.001). CONCLUSION: In the long-term follow-up placement of a non-absorbable synthetic prophylactic mesh in the context of an elective end colostomy does not seem effective for preventing PH.


Asunto(s)
Hernia Ventral , Hernia Incisional , Estomas Quirúrgicos , Anciano , Humanos , Masculino , Colostomía/efectos adversos , Colostomía/métodos , Estudios de Seguimiento , Hernia Ventral/etiología , Hernia Ventral/prevención & control , Hernia Ventral/diagnóstico , Herniorrafia , Hernia Incisional/etiología , Hernia Incisional/prevención & control , Hernia Incisional/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Mallas Quirúrgicas , Femenino
2.
Ann Oncol ; 34(1): 78-90, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36220461

RESUMEN

BACKGROUND: The standard treatment of T2-T3ab,N0,M0 rectal cancers is total mesorectal excision (TME) due to the high recurrence rates recorded with local excision. Initial reports of the combination of pre-operative chemoradiotherapy (CRT) and transanal endoscopic microsurgery (TEM) have shown reductions in local recurrence. The TAU-TEM study aims to demonstrate the non-inferiority of local recurrence and the improvement in morbidity achieved with CRT-TEM compared with TME. Here we describe morbidity rates and pathological outcomes. PATIENTS AND METHODS: This was a prospective, multicentre, randomised controlled non-inferiority trial including patients with rectal adenocarcinoma staged as T2-T3ab,N0,M0. Patients were randomised to the CRT-TEM or the TME group. Patients included, tolerance of CRT and its adverse effects, surgical complications (Clavien-Dindo and Comprehensive Complication Index classifications) and pathological results (complete response in the CRT-TEM group) were recorded in both groups. Patients attended follow-up controls for local and systemic relapse. TRIAL REGISTRATION: NCT01308190. RESULTS: From July 2010 to October 2021, 173 patients from 17 Spanish hospitals were included (CRT-TEM: 86, TME: 87). Eleven were excluded after randomisation (CRT-TEM: 5, TME: 6). Modified intention-to-treat analysis thus included 81 patients in each group. There was no mortality after CRT. In the CRT-TEM group, one patient abandoned CRT, 1/81 (1.2%). The CRT-related morbidity rate was 29.6% (24/81). Post-operative morbidity was 17/82 (20.7%) in the CRT-TEM group and 41/81 (50.6%) in the TME group (P < 0.001, 95% confidence interval 42.9% to 16.7%). One patient died in each group (1.2%). Of the 81 patients in the CRT-TEM group who received the allocated treatment, 67 (82.7%) underwent organ preservation. Pathological complete response in the CRT-TEM group was 44.3% (35/79). In the TME group, pN1 were found in 17/81 (21%). CONCLUSION: CRT-TEM treatment obtains high pathological complete response rates (44.3%) and a high CRT compliance rate (98.8%). Post-operative complications and hospitalisation rates were significantly lower than those in the TME group. We await the results of the follow-up regarding cancer outcomes and quality of life.


Asunto(s)
Neoplasias del Recto , Microcirugía Endoscópica Transanal , Humanos , Microcirugía Endoscópica Transanal/métodos , Resultado del Tratamiento , Estudios Prospectivos , Calidad de Vida , Recurrencia Local de Neoplasia/patología , Neoplasias del Recto/tratamiento farmacológico , Neoplasias del Recto/radioterapia , Neoplasias del Recto/cirugía , Quimioradioterapia , Terapia Neoadyuvante/efectos adversos , Terapia Neoadyuvante/métodos , Estadificación de Neoplasias
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