A Randomized Clinical Study On Three Different Sub-techniques Of Minimal Invasive Kshara Sutra Technique In Bhagandhar With Special Reference To Transsphincteric Fistula-in-ano .
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 1. Duration of Intervention (In minutes)
研究概览
简要总结
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will
be selected. All the participants who voluntarily agree to participate and provide informed written
consent for participation will be recruited in the study.
Total 45 participants will be selected after details examination and divided in 3 groups of 15 patients
each as per study protocol. All Procedures will be executed under aseptic condition . Patient
will be taken for assessment initially in pre-op and on 1st, 2nd, 3rd and 4th week of post-op period thereafter on every 15th day upto next 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Transsphicteric fistula-in-ano between the age group of 20 to 60 years of either sex.
- •Patients who have signs and symptoms of Bhagandhar /Fistula-in-ano of length of the tract more than 4cm from anal canal.
- •Patients who have signs and symptoms of uncomplicated and Recurrent Transsphincteric fistula.
排除标准
- •Transsphincteric fistula with a high blind track.
- •Patients with other systemic illnesses like uncontrolled Diabetesmellitus, Hypertension,Malignancy,Hepatitis B, Tuberculosis and Retrovirus positive.
- •Infective and Neoplastic conditions of rectum, Rectal prolapse.
- •Patients having Pelvic pathology and Pregnancy.
- •Patients not fit for anaesthesia.
结局指标
主要结局
1. Duration of Intervention (In minutes)
时间窗: Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
2. Change in pain score (VAS)
时间窗: Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
3. Change in discharge score
时间窗: Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
4. Change in wexner score (Incontinence)
时间窗: Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
5. Time taken for wound healing
时间窗: Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
次要结局
- 1. Length of Hospital stay.(2. Time to return to work.)