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.
Background The aim of this study was to review clinical outcome of haemorrhoidectomy and rubber band ligation in grade II–III haemorrhoids. Methods A systematic review was conducted. Medline, Embase, Cochrane Library, Clinicaltrials.gov, and the WHO International Trial Registry Platform were searched, from inception until May 2018, to identify randomised clinical trials comparing rubber band ligation with haemorrhoidectomy for grade II–III haemorrhoids. The primary outcome was control of symptoms. Secondary outcomes included postoperative pain, postoperative complications, anal continence, patient satisfaction, quality of life and healthcare costs were assessed. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results Three hundred and twenty-four studies were identified. Eight trials met the inclusion criteria. All trials were of moderate methodological quality. Outcome measures were diverse and not clearly defined. Control of symptoms was better following haemorrhoidectomy. Patients had less pain after rubber band ligation. There were more complications (bleeding, urinary retention, anal incontinence/stenosis) in the haemorrhoidectomy group. Patient satisfaction was equal in both groups. There were no data on quality of life and healthcare costs except that in one study patients resumed work more early after rubber band ligation. Conclusions Haemorrhoidectomy seems to provide better symptom control but at the cost of more pain and complications. However, due to the poor quality of the studies analysed/it is not possible to determine which of the two procedures provides the best treatment for grade II–III haemorrhoids. Further studies focusing on clearly defined outcome measurements taking patients perspective and economic impact into consideration are required.
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 = €555 (95% CI, €472–€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 ANTECEDENTES: 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. OBJETIVO: Comparar el efecto de la hemorroidectomía abierta mínima versus la desarterialización hemorroidal transanal en los síntomas reportados por el paciente. DISEÑO: Ensayo controlado aleatorizado abierto. ESCENARIO: Estudio en sede única. PACIENTES: Pacientes con enfermedad hemorroidal sintomática de grado II-IV (clasificación de Goligher). INTERVENCIONES: Los pacientes fueron asignados aleatoriamente a hemorroidectomía mínima abierta o desarterialización hemorroidal transanal. PRINCIPALES MEDIDAS DE RESULTADO: 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. RESULTADOS: 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%]: € 555 [472-693], p <0.001). LIMITACIONES: Estudio sin cegamiento. CONCLUSIÓN: 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). REGISTRO DE ENSAYOS: ClinicalTrials.gov Identifier: NCT02061176
Primary aldosteronism (PA) is the most common cause of secondary hypertension (HT). We describe here clinical characteristics, diagnostic procedures, and long-term outcomes in a Norwegian population. All suspected PA patients investigated at a tertiary centre from 1998–2012 were retrospectively evaluated. Inclusion criteria were verified PA after confirmatory testing or otherwise considered highly likely PA. Clinical, biochemical, radiological, and adrenal vein sampling (AVS) findings were analysed. Surgically removed adrenals were re-evaluated histopathologically and tested for somatic mutations. All patients still alive by August 2014 were invited to a follow-up visit. One-hundred and eight patients were included, of whom 85% had a history of hypokalaemia. PA was verified by confirmatory testing in 83 (77%), and AVS performed in 95 (88%) patients. The proportion with AVS-confirmed bilateral PA increased during the study period. Sixty-eight patients (63%) underwent adrenalectomy. KCNJ5 mutations were found in 30% of the surgical specimens and were associated with female sex and a florid PA phenotype. Follow-up visits were undertaken in 73/108 (68%), of whom 52 adrenalectomised. After adrenalectomy, 83% were biochemically cured of PA, but only 21% were cured for HT. Female sex, a verified adenoma, and KCNJ5 mutations were associated with cure of HT. In conclusion, the majority of our patients had unilateral PA and hypokalaemia, indicating that patients with bilateral and milder PA may still be underdiagnosed. Female sex, a histopathological adenoma, and the presence of KCNJ5 mutations predicted cure of HT after adrenalectomy, but the overall cure rate of HT was low.
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