A Randomised controlled trial to compare quality of life by SF36 questionnaire 06 months after the intervention between laser hemorrhoidoplasty versus open hemorrhoidectomy in Grade III and IV haemorrhoids at a tertiary care hospital
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Quality of life by SF36 questionnaire
研究概览
简要总结
Hemorrhoidal diseases rank first amongst ano-rectal diseases and have an estimated prevalence of 2.9-27% of which 4% are symptomatic. Multiplicity of treatment modalities has added confusion in decision making regarding treatment method to be chosen. Milligan-Morgan open hemorrhoidectomy remains the gold standard of surgery. However, it is associated with significant complications including pain, bleeding, wound infection which prologn hospital stay and decease subsequent quality of life. This study is to assess the difference in quality of life in open hemorrhoidectomy versus Laser hemorrhoidoplasty using SF36 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •grade III hemorrhoids grade IV hemorrhoids Able to give informed consent.
排除标准
- •Younger than 18 years Patients unable to give informed consent Spinal anaesthesia contraindicated Patients with other and-rectal conditions associated.
- •fissure-in-ano, fistula-in-ano Patients who have undergone interventions for haemorrhoids in the past.
结局指标
主要结局
Quality of life by SF36 questionnaire
时间窗: at 06 months
次要结局
未报告次要终点
研究者
Brig Alok Bhalla
armed forces medical college
