Gustavo Arruda Viani1,2,3, Aline Sakamoto4. 1. Oncoclinicas institute, São Paulo, Brazil. gusviani@gmail.com. 2. Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRP-USP), Ribeirão Preto, SP, Brazil. gusviani@gmail.com. 3. Faculdade de Medicina de Marília (FAMEMA), Marília, SP, Brazil. gusviani@gmail.com. 4. Faculdade de Medicina de Marília (FAMEMA), Marília, SP, Brazil.
Abstract
PURPOSE: The aim of this quasi-experimental study is to evaluate a novel technique for an outpatient application of formalin for chronic rectal bleeding after prostate irradiation. METHODS: This is a quasi- experimental clinical trial developed between January 2010 and July 2015, including 35 patients with chronic radiation rectitis (CRP) due to a previous prostate radiation course. The study's eligibility was (1) completed external beam radiation therapyfor prostate carcinoma >6 months previously, (2) rectal bleeding, defined as a frequency of >1× per week and/or needing of blood transfusions, and (3) diagnosis of chronic proctitis at colonoscopy. The 5% formalin application was performed by a custom applicator, which requires neither anesthesia nor sigmoidoscopy. The endpoint of the study was bleeding cessation and hemoglobin level. RESULTS: The onset of bleeding due to chronic rectitis was 12 months (6-36). During a median follow-up of 24 months, the rate of overall efficacy was 94%. The sustained complete response in 1 and 2 years was 80% and 73%, respectively. The Hb mean pre- and post-treatment differed significantly (12.2 vs 14.4, p = 0.0001). The rates of blood transfusion differed significantly, pre- and post-treatment (17% vs 5.7%, p = 0.031). CONCLUSION: The technique is very effective and safe, resulting to a significant improvement of hemoglobin levels and quality of life scores. Further studies are warranted to compare this technique with other treatment options for chronic radiation-induced rectal bleeding.
RCT Entities:
PURPOSE: The aim of this quasi-experimental study is to evaluate a novel technique for an outpatient application of formalin for chronic rectal bleeding after prostate irradiation. METHODS: This is a quasi- experimental clinical trial developed between January 2010 and July 2015, including 35 patients with chronic radiation rectitis (CRP) due to a previous prostate radiation course. The study's eligibility was (1) completed external beam radiation therapy for prostate carcinoma >6 months previously, (2) rectal bleeding, defined as a frequency of >1× per week and/or needing of blood transfusions, and (3) diagnosis of chronic proctitis at colonoscopy. The 5% formalin application was performed by a custom applicator, which requires neither anesthesia nor sigmoidoscopy. The endpoint of the study was bleeding cessation and hemoglobin level. RESULTS: The onset of bleeding due to chronic rectitis was 12 months (6-36). During a median follow-up of 24 months, the rate of overall efficacy was 94%. The sustained complete response in 1 and 2 years was 80% and 73%, respectively. The Hb mean pre- and post-treatment differed significantly (12.2 vs 14.4, p = 0.0001). The rates of blood transfusion differed significantly, pre- and post-treatment (17% vs 5.7%, p = 0.031). CONCLUSION: The technique is very effective and safe, resulting to a significant improvement of hemoglobin levels and quality of life scores. Further studies are warranted to compare this technique with other treatment options for chronic radiation-induced rectal bleeding.
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