A Prospective Assessment of Surgical Treatments in Hemorrhoidal Disease: Real-life Practice and Early Outcome in Terms of Patient-reported Symptoms and Quality of Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery
研究概览
简要总结
This study aims to evaluate the effect of surgical treatments on the quality of life in hemorrhoidal disease. All available treatment methods will be included in this 1-year cohort which is going to collect data from a big metropol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical interventions under local and/or general anesthesia
- •Elective or emergency interventions (including thrombectomy)
- •Surgical interventions in operation room or office
- •Any kind of excision, sclerotherapy, ligation, suturation, ablation, mucopexy
排除标准
- •Any accompanying perianal disease (anal fistula, anal fissure, perianal abscess, anal condyloma extending into the anal canal)
- •Previous surgery for hemorrhoids (any intervention other than medical treatment)
- •Previous perianal surgery (internal sphincterotomy, fistula surgery)
- •Pelvic and/or perineal radiotherapy
- •Previous obstetric or perianal injury and/or sphincter repair
- •Previous rectal surgery (distal colectomy for benign or malignant etiology)
结局指标
主要结局
Improvement in Short Health Scale-HD score at 1 year after hemorrhoidal surgery
时间窗: 1 year
Changes in quality of life from baseline at 1 year in terms of Short Health Scale (SHS) specific to hemorrhoidal disease (HD) will be reported for each surgical treatment. The SHS-HD scores will be recorded preoperatively, at 1 week, 6 weeks, and 12 months.
Hemorrhoidal Disease Symptom Score at 1 year after hemorrhoidal surgery
时间窗: 1 year
Changes in symptoms from baseline at 1 year will be reported for each surgical treatment. Hemorrhoidal Disease Symptom Score (HDSS) described by Nyström based on 5 cardinal symptoms (pain, itching, bleeding, soiling, and prolapse) will be recorded preoperatively, at 1 week, 6 weeks, and 12 months.
次要结局
- Recurrence(1 year)
- Complications(1 year)