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临床试验/CTRI/2024/02/062690
CTRI/2024/02/062690招募中2 期

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

未提供1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2024年3月20日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Brig Alok Bhalla

armed forces medical college

研究点 (1)

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