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Preliminary Results of Open Excisional Hemorrhoidectomy Combined With 3% Polidocanol Foam Sclerotherapy in Patients
Xiangyi Yin1, Jiaqi Jiang1, Biao Liang1
1Department of Anorectal Surgery, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Background:
The Milligan-Morgan hemorrhoidectomy remains the criterion standard for grade IV hemorrhoidal disease. However, postoperative pain, bleeding, and prolonged recovery persist as challenges. Sclerotherapy shows promise but lacks evidence in grade IV hemorrhoidal disease management.
Objective:
This study evaluated the efficacy and safety of open excisional hemorrhoidectomy (Milligan-Morgan hemorrhoidectomy) combined with 3% polidocanol foam sclerotherapy in patients with grade IV hemorrhoidal disease.
Design:
A randomized, open-label, single-center clinical trial.
Settings:
Department of Anorectal Surgery, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.
Patients:
Thirty-six patients aged 18 to 75 years with grade IV hemorrhoidal disease were enrolled and randomized equally to 2 groups.
Interventions:
The experimental group underwent Milligan-Morgan hemorrhoidectomy combined with 3% polidocanol foam sclerotherapy; the control group underwent Milligan-Morgan hemorrhoidectomy with no additional therapy.
Main Outcome Measures:
The primary outcome was the time to return to daily activities. Secondary outcomes included Hemorrhoidal Disease Symptom Score, Vaizey Incontinence scores, visual analog scale score, Short Health Scale for Hemorrhoidal Disease scores, postoperative bleeding grade, usage of analgesics, and satisfaction.
Results:
The experimental group demonstrated a mean 5.78-day earlier return to normal activities and work than the control group (mean ± SD: 19.28 ± 8.35 vs 25.06 ± 7.85 days; 95% CI, -11.27 to -0.29 days; p = 0.04), reduced postoperative bleeding (0-3 scale; estimate -0.45; 95% CI, -0.72 to -0.16; p = 0.002), lower analgesic use (0-3 scale; estimate -0.38; 95% CI, -0.66 to -0.09; p = 0.009), and improved symptom scores at 1 to 2 months (Z -2.52 and -2.11, p < 0.05). Median satisfaction scores were 10 versus 9.5 ( p = 0.12). No adverse events occurred.
Limitations:
Small sample size, nonblinded, single-center design, and short follow-up period.
Conclusions:
Milligan-Morgan hemorrhoidectomy combined with 3% polidocanol foam sclerotherapy significantly enhanced postoperative recovery, reduced complications, and demonstrated comparable patient satisfaction. Long-term follow-up is warranted to validate sustained efficacy. See Video Abstract.
Clinical Trial Registration:
Chinese Clinical Trial Registry: ChiCTR2400087552.
Resultados Preliminares De La Hemorroidectoma Abierta Combinada Con Escleroterapia Con Espuma De Polidocanol Al En Pacientes Con Enfermedad Hemorroidal De Grado Iv Estudio Aleatorizado, Controlado, Abierto Y Unicntrico:
ANTECEDENTES:La hemorroidectomía de Milligan-Morgan sigue siendo el tratamiento de referencia para la enfermedad hemorroidal de grado IV. Sin embargo, el dolor postoperatorio, el sangrado y la recuperación prolongada siguen siendo un reto. La escleroterapia es prometedora, pero carece de evidencia en el tratamiento de la enfermedad hemorroidal de grado IV.Objetivo:Este estudio evaluó la eficacia y la seguridad de la hemorroidectomía por escisión abierta (hemorroidectomía de Milligan-Morgan) combinada con escleroterapia con espuma de polidocanol al 3 % en pacientes con enfermedad hemorroidal de grado IV.DISEÑO:Ensayo clínico aleatorizado, abierto y unicéntrico.ENTORNO:Departamento de Cirugía Anorrectal, Hospital Yueyang de Medicina Tradicional China y Occidental Integrada, Shanghái, China.PACIENTES:Se inscribieron 36 pacientes de entre 18 y 75 años con enfermedad hemorroidal de grado IV, que se distribuyeron aleatoriamente en dos grupos iguales.INTERVENCIONES:El grupo experimental recibió una hemorroidectomía Milligan-Morgan combinada con escleroterapia con espuma de polidocanol al 3 %; el grupo de control recibió una hemorroidectomía Milligan-Morgan.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal es el tiempo de retorno a las actividades diarias. Resultados secundarios: puntuación de los síntomas de la enfermedad hemorroidal, puntuaciones de incontinencia de Vaizey, escala analógica visual, puntuaciones de la escala breve de salud para la enfermedad hemorroidal, grado de sangrado postoperatorio, uso de analgésicos y satisfacción.RESULTADOS:El grupo experimental demostró una media de 5,78 días menos para volver a las actividades normales y al trabajo que el grupo de control (media ± DE: 19,28 ± 8,35 frente a 25,06 ± 7,85 días, IC del 95 %: -11,27 a -0,29 días, p = 0,04), reducción de la hemorragia posoperatoria (escala de 0 a 3, estimación: -0,45, IC del 95 %: -0,72 a -0,16, p = 0,002), menor uso de analgésicos (escala de 0 a 3, estimación: -0,38, IC del 95 %: -0,66 a -0,09, p = 0,009) y mejora de las puntuaciones de los síntomas a los 1-2 meses (Z -2,52 y -2,11, p < 0,05). Las puntuaciones medias de satisfacción fueron de 10 frente a 9,5 ( p = 0,12). No se produjeron acontecimientos adversos.LIMITACIONES:Tamaño reducido de la muestra, diseño no ciego, centro único y periodo de seguimiento corto.CONCLUSIONES:La hemorroidectomía de Milligan-Morgan combinada con escleroterapia con espuma de polidocanol al 3 % mejora significativamente la recuperación posoperatoria, reduce las complicaciones y demuestra una satisfacción comparable de los pacientes. Se justifica un seguimiento a largo plazo para validar la eficacia sostenida. Número de registro del ensayo clínico: Registro chino de ensayos clínicos: ChiCTR2400087552. ( AI-generated translation ).
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