Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial.

BACKGROUND: There is limited evidence on the long-term efficacy of transanal hemorrhoidal dearterialization compared with hemorrhoidectomy. Most studies investigated short-term effects with postoperative pain as the primary outcome. Being a benign disease, the long-term goal of treatment for hemorrhoids is the resolution of symptoms and improvement of quality of life. OBJECTIVE: The purpose of this study was to compare the effect of minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization on patient-reported symptoms. DESIGN: This was an open-label randomized controlled trial. SETTINGS: This was a single-center study. PATIENTS: Patients with symptomatic hemorrhoids grade II to IV (Goligher's classification) were included. INTERVENTIONS: Patients were randomly allocated to minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization. MAIN OUTCOME MEASURES: The primary outcome was symptoms assessed by the Hemorrhoidal Disease Symptom Score 1 year postoperatively. Secondary outcomes included health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence, and hospital costs. RESULTS: Forty-eight patients received minimal open hemorrhoidectomy, and 50 patients received transanal hemorrhoidal dearterialization. No difference in symptom score at 1-year follow-up was found. Median (range) symptom score was 3 (0-17) after minimal open hemorrhoidectomy and 5 (0-17) after transanal hemorrhoidal dearterialization (median difference = -1.0 (95% CI, -3.0 to 0.0); p = 0.15). Residual hemorrhoidal prolapse was reported more frequently (p = 0.008), and more patients had treatment for recurrence after transanal hemorrhoidal dearterialization (7 vs 0 patients; p = 0.013). Patient satisfaction was higher after minimal open hemorrhoidectomy (p = 0.049). No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p > 0.05). Transanal hemorrhoidal dearterialization was more expensive (median difference = &OV0556;555 (95% CI, &OV0556;472-&OV0556;693); p < 0.001). LIMITATIONS: No blinding was included in this study. CONCLUSION: No difference was found in symptom score 1 year postoperatively. Minimal open hemorrhoidectomy had a better effect on the hemorrhoidal prolapse and higher patient satisfaction. More patients needed treatment for recurrence after transanal hemorrhoidal dearterialization. Minimal open hemorrhoidectomy has an immediate postoperative course similar to transanal hemorrhoidal dearterialization. See Video Abstract at http://links.lww.com/DCR/B152. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02061176. HEMORROIDECTOMíA MíNIMA ABIERTA VERSUS DESARTERIALIZACIóN HEMORROIDAL TRANSANAL: EL EFECTO SOBRE LOS SíNTOMAS: UN ESTUDIO ABIERTO CONTROLADO Y ALEATORIZADO: Hay evidencia limitada sobre la eficacia a largo plazo de la desarterialización hemorroidal transanal en comparación con la hemorroidectomía. La mayoría de los estudios han investigado los efectos a corto plazo con el dolor postoperatorio como el resultado primario. Al ser una enfermedad benigna, el objetivo a largo plazo del tratamiento de la enfermedad hemorroidal es la resolución de los síntomas y la mejora en la calidad de vida.Comparar el efecto de la hemorroidectomía abierta mínima versus la desarterialización hemorroidal transanal en los síntomas reportados por el paciente.Ensayo controlado aleatorizado abierto.Estudio en sede única.Pacientes con enfermedad hemorroidal sintomática de grado II-IV (clasificación de Goligher).Los pacientes fueron asignados aleatoriamente a hemorroidectomía mínima abierta o desarterialización hemorroidal transanal.El resultado primario fueron los síntomas evaluados por el Score de Síntomas de Enfermedad Hemorroidal un año después de la operación. Los resultados secundarios incluyeron calidad de vida relacionada con la salud, satisfacción del paciente, dolor y recuperación postoperatorios, eventos adversos, recurrencia y costos hospitalarios.Cuarenta y ocho pacientes recibieron hemorroidectomía abierta mínima y cincuenta pacientes recibieron desarterialización hemorroidal transanal. No se encontraron diferencias en la puntuación de los síntomas al año de seguimiento. La puntuación mediana (rango) de síntomas fue 3 (0-17) después de una hemorroidectomía mínima abierta y 5 (0-17) después de la desarterialización hemorroidal transanal (diferencia mediana [IC95%]: -1.0 [-3.0-0.0], p = 0.15). El prolapso hemorroidal residual se informó con mayor frecuencia (p = 0.008) y más pacientes recibieron tratamiento por recurrencia después de la desarterialización hemorroidal transanal (7 frente a 0 pacientes, p = 0.013). La satisfacción del paciente fue mayor después de una hemorroidectomía abierta mínima (p = 0.049). No se encontraron diferencias en el impacto sobre la calidad de vida relacionada con la salud, el dolor postoperatorio promedio y máximo, la recuperación o los eventos adversos (p> 0.05). La desarterialización hemorroidal transanal fue más costosa (diferencia mediana [IC95%]: &OV0556; 555 [472-693], p <0.001).Estudio sin cegamiento.No se encontraron diferencias en la puntuación de los síntomas a un año después de la operación. La hemorroidectomía mínima abierta tuvo un mejor efecto sobre el prolapso hemorroidal y una mayor satisfacción del paciente. Más pacientes necesitaron tratamiento para la recurrencia después de la desarterialización hemorroidal transanal. La hemorroidectomía abierta mínima tiene un curso postoperatorio inmediato similar a la desarterialización hemorroidal transanal. Consulte Video Resumen en http://links.lww.com/DCR/B152. (Traducción-Dr. Jorge Silva Velazco).ClinicalTrials.gov Identifier: NCT02061176.

Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease.

BACKGROUND: There are no adequately validated tools to evaluate symptoms or disease-specific health-related quality of life in hemorrhoidal disease. OBJECTIVE: The purpose of this study was to assess validity, reliability, and responsiveness of a symptom score of patient-reported pain, itching, bleeding, soiling, and prolapse (Hemorrhoidal Disease Symptom Score). In addition, the study set out to assess reliability and responsiveness of an instrument to measure health-related quality of life in patients with hemorrhoids (Short Health ScaleHD), with 1 item in its 4 dimensions: symptom load, functional status, disease-specific worries, and general well-being. DESIGN: This was a cross-sectional (validity and reliability) and longitudinal (responsiveness) study. SETTINGS: The study was conducted at a single center. PATIENTS: Cohort 1 included 295 patients with hemorrhoids to study validity and 60 patients with test-retest scores to study reliability. Cohort 2 included 128 and 121 patients operated for hemorrhoids to study responsiveness of the Hemorrhoidal Disease Symptom Score and the Short Health ScaleHD. MAIN OUTCOME MEASURES: The study evaluated validity, reliability, and responsiveness. Patient-reported symptom load on a 7-point Likert scale was used as comparator, and receiver operating characteristics curve assessed discriminative validity. Interclass correlation assessed reliability. Receiver operating characteristics curve assessed responsiveness, meaning the ability to discriminate between patients with and without improvement after surgery. RESULTS: The Hemorrhoidal Disease Symptom Score demonstrated the ability to discriminate between patients reporting high or low symptom load (area under the curve = 0.786 (95% CI, 0.725-0.848)). The Hemorrhoidal Disease Symptom Score and the Short Health ScaleHD demonstrated adequate reliability and responsiveness, with interclass correlation of 0.822 (95% CI, 0.715-0.891) and 0.763 (95% CI, 0.634-0.851) and area under the curve of 0.843 (95% CI, 0.756-0.929) and 0.840 (95% CI, 0.752-0.929). LIMITATIONS: We had no gold standard comparator to assess validity and responsiveness. CONCLUSIONS: The findings suggest that the Hemorrhoidal Disease Symptom Score is valid, reliable, and responsive and that the Short Health ScaleHD is reliable and responsive. Used together, these tools provide a good overview of symptoms and their impact on patient well-being. See Video Abstract at http://links.lww.com/DCR/A770.