ABSTRACT
Abstract Objective Human amniotic membrane (HAM) used as a wound coverage for more than a century. The aim of this study is to evaluate the efficacy of amniotic membrane on wound healing and reduce post-operative complication. Study design Randomized clinical trial study. Place and duration of study Surgery Department, Shahid Faghihi Hospital, Shiraz, in the period of between Sep. 2014 and Nov. 2015. Methodology 73 patients with anal fistula were divided into two groups. The patients suffered from simple perianal fistula (low type) without any past medical history. Fistulotomy were performed for all of them and in interventional group HAM were applied as biologic dressing. Their wound healing improvement was evaluated post-operative in two groups. Results From 73 patients participated in the study, 36 patients were in control group and 37 patients were in intervention group. According to the analysis of images taken from the wound, the rate of wound healing was 67.39% in intervention group and 54.51% in control group (p < 0.001). Discharge, pain, itching and stool incontinency was lower in intervention group. Analysis of pathology samples taken from the wound showed no differences between two groups. Conclusion HAM application could lead to improvement of wound healing and reduced post-operative complications. In conclusion, HAM may act as a biologic dressing in the patients with anal fistula.
Resumo Objetivo Membrana amniótica humana (MAH) tem sido usada para cobrir feridas por mais de um século. O objetivo deste estudo é avaliar a eficácia da membrana amniótica na cicatrização de feridas e reduzir complicações pós-operatórias. Desenho do estudo Ensaio clínico randomizado. Local e duração do estudo Departamento de Cirurgia, Shahid Faghihi Hospital, Shiraz, Irã, entre setembro de 2014 a novembro de 2015. Método 73 pacientes com fístula anal foram divididos em dois grupos. Os pacientes sofriam de fístula perianal simples (tipo baixo) sem histórico médico prévio. A fistulotomia foi realizada em todos eles e no grupo intervenção, MAH foi aplicada como curativo biológico. A melhora da cicatrização foi avaliada no período pós-operatório em dois grupos. Resultados De 73 pacientes que participaram do estudo, 36 pacientes eram do grupo controle e 37 pacientes do grupo intervenção. De acordo com a análise das imagens da ferida, a taxa de cicatrização foi 67,39% no grupo intervenção e 54,51% no grupo controle (p < 0,001). Secreção, dor, prurido e incontinência fecal foi menor no grupo intervenção. A análise das amostras patológicas retiradas da ferida não mostrou diferenças entre os dois grupos. Conclusão A aplicação de MAH pode levar à melhoria da cicatrização de feridas e reduzir as complicações pós-operatórias. Em conclusão, a MAH pode atuar como um curativo biológico nos pacientes com fístula anal.
Subject(s)
Humans , Male , Female , Rectal Fistula/surgery , Amnion/injuries , Postoperative Complications/surgery , Wound Healing/physiology , Biological DressingsABSTRACT
PURPOSE: Despite advances in rectal cancer treatment over the last decade, local control and risk of late side effects due to external beam radiation therapy (EBRT) remain as concerns. The present study aimed to investigate the efficacy and the safety of low-dose-rate endorectal brachytherapy (LDRBT) as a boost to neoadjuvant chemoradiation for use in treating locally advanced distal rectal adenocarcinomas. METHODS: This phase-II clinical trial included 34 patients (as the study arm) with newly diagnosed, locally advanced (clinical T3-T4 and/or N1/N2, M0) lower rectal cancer. For comparative analysis, 102 matched patients (as the historical control arm) with rectal cancer were also selected. All the patients were treated with LDRBT (15 Gy in 3 fractions) and concurrent chemoradiation (45-50.4 Gy). Concurrent chemotherapy consisted of oxaliplatin 130 mg/m2 intravenously on day 1 plus oral capecitabine 825 mg/m2 twice daily during LDRBT and EBRT. RESULTS: The study results revealed a significant differences between the study arm and the control arm in terms in the pathologic tumor size (2.1 cm vs. 3.6 cm, P = 0.001), the pathologic tumor stage (35% T3-4 vs. 65% T3-4, P = 0.003), and the pathologic complete response (29.4% vs. 11.7%, P < 0.028). Moreover, a significantly higher dose of EBRT (P = 0.041) was found in the control arm, and a longer time to surgery was observed in the study arm (P < 0.001). The higher rate of treatment-related toxicities, such as mild proctitis and anemia, in the study arm was tolerable and easily manageable. CONCLUSION: A boost of LDRBT can optimize the pathologic complete response, with acceptable toxicities, in patients with distal rectal cancer.
