ABSTRACT
BACKGROUND: Both transanal hemorrhoidal dearterialization and vessel-sealing device hemorrhoidectomy are safe for grade III to IV hemorrhoid treatment. Whether one of them is superior regarding long-term results remains unclear. OBJECTIVE: To compare long-term results after transanal hemorrhoidal dearterialization and vessel-sealing device hemorrhoidectomy. DESIGN: Multicenter randomized controlled trial. SETTINGS: This study was conducted at 6 centers. PATIENTS: Patients ≥18 years of age with grade III to IV hemorrhoids were included in the study. INTERVENTIONS: Patients were randomly assigned to transanal hemorrhoidal dearterialization (n = 39) or vessel-sealing device hemorrhoidectomy (n = 41). MAIN OUTCOME MEASURES: The primary outcome was hemorrhoid symptom recurrence assessed by a specific questionnaire 2 years postoperatively. Secondary outcomes included long-term complications, reoperations, fecal continence, and patient satisfaction and quality of life. RESULTS: Five of the 80 patients included in the study were lost to follow-up. Thirty-six patients randomly assigned to transanal hemorrhoidal dearterialization and 39 patients randomly assigned to vessel-sealing device hemorrhoidectomy were included in the long-term analysis. The differences between mean baseline and mean 2-year score in the 2 groups were similar (-11.0, SD 3.8 vs -12.5, SD 3.6; p = 0.080). Three patients in the transanal hemorrhoidal dearterialization group underwent supplementary procedures for hemorrhoid symptoms, compared with none in the vessel-sealing device hemorrhoidectomy group ( p = 0.106). Four patients in the vessel-sealing hemorrhoidectomy group and none in the transanal hemorrhoidal dearterialization group experienced chronic opened wound ( p = 0.116). LIMITATIONS: Lack of stratification for hemorrhoid grade and power calculation based on the main outcome trial but not on the end point of this long-term study. CONCLUSIONS: Transanal hemorrhoidal dearterialization with mucopexy is associated with hemorrhoid symptom recurrence similar to vessel-sealing device hemorrhoidectomy at 2 years. See Video Abstract at http://links.lww.com/DCR/B933 . REGISTRATION: Clinicaltrials.gov ; ID: NCT02654249. DESARTERIALIZACIN HEMORROIDAL TRANSANAL CON MUCOPEXIA VERSUS HEMORROIDECTOMA CON DISPOSITIVO DE SELLADO DE VASOS PARA HEMORROIDES DE GRADO IIIIV RESULTADOS A LARGO PLAZO DEL ENSAYO CLNICO ALEATORIZADO THDLIGARCT: ANTECEDENTES:Tanto la desarterialización hemorroidal transanal como la hemorroidectomía con dispositivo de sellado de vasos son seguras y bien toleradas para el tratamiento de las hemorroides de grado III-IV. La primera se asocia con una necesidad más breve de analgesia posoperatoria que la hemorroidectomía con dispositivo de sellado de vasos. No está claro si uno de ellos es superior con respecto a los resultados a largo plazo.OBJETIVO:El objetivo fue comparar los resultados a largo plazo después de la desarterialización hemorroidal transanal y la hemorroidectomía con dispositivo de sellado de vasos.DISEÑO:Se realizó un ensayo clínico aleatorizado multicéntrico.AJUSTE:Este estudio se realizó en 6 centros.PACIENTES:Se incluyeron en el estudio pacientes de ≥18 años con hemorroides de grado III-IV.INTERVENCIONES:Los pacientes fueron asignados al azar a desarterialización hemorroidal transanal (n = 39) o hemorroidectomía con dispositivo de sellado de vasos (n = 41).PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la recurrencia de los síntomas de hemorroides evaluada mediante un cuestionario específico 2 años después de la operación. Los resultados secundarios incluyeron complicaciones a largo plazo, reoperaciones, continencia fecal, satisfacción del paciente y calidad de vida.RESULTADOS:Cinco de los 80 pacientes incluidos en el estudio se perdieron durante el seguimiento. En el análisis a largo plazo se incluyeron 36 pacientes aleatorizados a desarterialización hemorroidal transanal y 39 aleatorizados a hemorroidectomía con dispositivo de sellado de vasos. Las diferencias entre la puntuación inicial media y la puntuación media a los 2 años en los dos grupos fueron similares (-11,0, DE 3,8 frente a -12,5, DE 3,6; p = 0,080). Tres pacientes en el grupo de desarterialización hemorroidal transanal se sometieron a procedimientos complementarios por síntomas de hemorroides, en comparación con ninguno en el grupo de hemorroidectomía con dispositivo de sellado de vasos (p = 0,106). Cuatro pacientes en el grupo de hemorroidectomía con sellado de vasos y ninguno en el grupo de desarterialización hemorroidal transanal experimentaron herida abierta crónica (p = 0,116). No se encontraron diferencias en cuanto a continencia fecal (p = 0,657), satisfacción del paciente (p = 0,483) y calidad de vida.LIMITACIONES:No hay estratificación para el grado de hemorroides ni el cálculo del poder basado en el resultado principal del ensayo, pero no en el criterio de valoración de este estudio a largo plazo.CONCLUSIONES:La desarterialización hemorroidal transanal con mucopexia se asocia con una recurrencia de síntomas de hemorroides similar a la hemorroidectomía con dispositivo de sellado de vasos a los dos años. See Video Abstract at http://links.lww.com/DCR/B933 . (Traducción- Dr. Francisco M. Abarca-Rendon )REGISTRO DE PRUEBA:Clinicaltrials.gov (NCT02654249).
Subject(s)
Hemorrhoidectomy , Hemorrhoids , Humans , Hemorrhoids/surgery , Quality of Life , Rectum/surgery , Patient Satisfaction , Retrospective StudiesABSTRACT
BACKGROUND: Transanal hemorrhoidal dearterialization with mucopexy and vessel-sealing device hemorrhoidectomy seem to reduce postoperative pain compared with classic excisional hemorrhoidectomy, but whether one of them is superior remains unclear. OBJECTIVE: We compared transanal hemorrhoidal dearterialization with mucopexy and vessel-sealing device hemorrhoidectomy. DESIGN: This was a multicenter, randomized controlled trial. SETTING: The study was conducted at 6 Spanish centers. PATIENTS: Patients aged ≥18 years with grade III to IV hemorrhoids were included. INTERVENTIONS: Patients were randomly assigned to transanal hemorrhoidal dearterialization with mucopexy (n = 39) or vessel-sealing device hemorrhoidectomy (n = 41). MAIN OUTCOME MEASURES: Primary outcome was the mean postoperative number of days in which patients needed nonsteroidal anti-inflammatory drugs. Secondary outcomes were postoperative pain, 30-day morbidity, patient satisfaction, Vaizey score, hemorrhoid symptoms score, return to work, and quality of life. RESULTS: More patients were still taking analgesia in the vessel-sealing device hemorrhoidectomy group during the second postoperative week compared with the transanal hemorrhoidal dearterialization with mucopexy group (87.8% vs 53.8%; p = 0.002). For the transanal hemorrhoidal dearterialization with mucopexy group, analgesia consumption continued until day 10.1 (mean; SD = 7.22 d), whereas in the vessel-sealing device hemorrhoidectomy group it continued until day 15.2 (mean; SD = 8.70 d; p = 0.006). The mean daily average pain was similar during the first (p = 0.900) and second postoperative weeks (p = 0.265). Mean operative time was higher for the transanal hemorrhoidal dearterialization with mucopexy group versus the vessel-sealing device hemorrhoidectomy group (45 min; range, 40-60 vs 20 min; range, 15-41 min; p < 0.001). Postoperative complications rate, use of laxatives, patient satisfaction, Vaizey score, hemorrhoids symptoms score, return to work, and quality of life at 1 month after surgery were similar between groups. LIMITATIONS: The main limitation of this study was that the 2 groups did not contain equal numbers of grade III and IV hemorrhoids. CONCLUSIONS: Transanal hemorrhoidal dearterialization with mucopexy is associated with a shorter need for postoperative analgesia compared with vessel-sealing device hemorrhoidectomy. See Video Abstract at http://links.lww.com/DCR/A915. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02654249.
