A Comparative study of ligation of fistulous track in the inter-sphincteric plane(LIFT) versus interception of fistulous track with application of ksharsutra (IFTAK) in the management of Bhagandara with special reference to trans-sphincteric fistula-in-ano.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cutting and Healing of Fistulous Track
研究概览
简要总结
Objective: To compare the efficacy ligation of fistulous track in the inter-sphincteric plane(LIFT) versus interception of fistulous track with application of ksharsutra (IFTAK) in the management of Bhagandara with special reference to trans-sphincteric fistula-in-ano.
Paticipants:60 Adults diagnosed with bhagandara meeting inclusion and exclusion criteria from OPD and IPD of department of Shalya Tantra of Government PG Ayurvedic Medical College and Hospital Chaukaghat, Varanasi.
Interventions:
30 patients-LIFT Procedure: Administered according to a standardized protocol.
30 patients-IFTAK Procedure : Administered according to a standardized protocol.
Primary Outcome: 1) Cutting and Healing of Fistulous Track.
Secondary Outcomes: 1)Reduce pus discharge, cure burning sensation and pain, increase quality of life, regulates bowel habit.
Follow up- Depends upon length of fistulous track.
Time Period: Depends upon length of fistulous track.
Data Analysis: Data will be analyzed using appropriate statistical methods to compare the effectiveness of the interventions on the primary and secondary outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Non-healing boil like structure at perianal area 2)Itching at perianal region 3)Constipation 4)Age between 20-60 years.
- •Trans-sphincteric fistula in ano 6)Horse shoe fistula in ano 7)Patient irrespective of occupation, sex and religion will be considered for study.
排除标准
- •Fissure-in-ano 2)Inter-sphincteric fistula in ano 3)Supra-sphincteric fistula in ano 4)Extra-sphincteric fistula in ano 5)Thrombosed pile mass.
- •First and second degree haemorrhoids 7)Third and fourth degree haemorrhoids.
- •The pathological conditions such as HIV I & II, HBsAg ,HCV.
- •will be excluded from the study.
- •Pregnancy.
- •Uncontrolled diabetes.
- •Anaemic patients.
- •Any other systemic disease.
- •Age below 20year and above 60 year 15)Addiction-drug, alchol, tobacco etc.
结局指标
主要结局
Cutting and Healing of Fistulous Track
时间窗: 28-42Days
次要结局
- Reduce pus discharge,cure burning sensation & pain,increase quality of life,regulates bowel habit.(3-4Months)
研究者
Dr Vibhav Dwivedi
Government Ayurvedic PG College And Hospital Chaukaghat Varanasi