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临床试验/CTRI/2021/04/033012
CTRI/2021/04/033012已完成不适用

TREATMENT OF TRANS-SPHINCTERIC FISTULA-IN-ANO WITH COMBINED THERAPY OF LASER AND KSHARA SUTRA - A CLINICAL STUDY.

Dept of Shalya Tantra1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月26日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Treatment of BHAGANDAR

研究概览

简要总结

60 Patients are registered and divided into two groups. Each group consist of 30 patients but in 2 patients from group A and 1 patient from group B are dropped out so all data given in 57 patients only  . Group A- conventional Kshara Sutra ligation. Group B- LASER therapy with Kshara Sutra Application as SMAK technique.

In group A- conventional kshara sutra ligation will be done from external opening to internal opening by probing. In group B- The Diode LASER (Radial Fiber) ablation done from external opening up to the level lateral to submucosa and from submucosa to the internal opening Kshara Sutra will be applied as submucosal application of Kshara Sutra (SMAK) technique.

Then to enhance the healing of wound by the application of hot sitz bath, proper cleaning of wound with sterile gauze.adjuvent therapy includes haritaki churna 5gm H.S

above study clinically assest on pain,itching,and discharge.it showed that after four follow up group A showed  82.63%relief in pain,92.02%in itching,81.82% in discharge while Group B showed 100% result in pain,itching,discharge and P value showed <0.001 which is highly significant but if analyse the full course of complete remission of fistula -Group B(trial group) showed complete remission at 42th day and Group A(controlled group) showed at 63th day.

Chi-squre,wicoxom(Z) and ,independent test applied for statistical analysis.

conclusion was that treatment given in both group are highly significant but trial group showed better result in terms of less pain,itching and discharge,less hospital visits,less discomfort,early returned to the normal life.

研究设计

研究类型
Interventional
分配方式
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Only trans-sphincteric fistula will be entertained.
  • Patient of Bhagandar those medically fit for surgery irrespective of Patient either sex, occupation and religion will be included randomly.
  • Patient suffering from Bhagandar will be taken.
  • Age of patient 18-60 years will be included.
  • Simple anal fistula with palpable induration.

排除标准

  • High anal fistula.
  • Branched trans-sphincteric fistula.
  • Supralevator fistula.
  • Subcutaneous fistula.
  • Fistula other than trans sphincteric fistula.
  • Fistula other than ano rectal region.
  • Tuberculosis.
  • Osteomyelitis.
  • Chronic or Acute Ulcerative colitis.
  • Crohn’s disease.
  • Any malignancy.
  • Venereal disease, HIV and HBsAg positive cases.
  • Rectal prolapse.
  • Complex fistula.

结局指标

主要结局

Treatment of BHAGANDAR

时间窗: 8week

次要结局

  • Treatment of BHAGANDAR(4 weeks)

研究者

发起方
Dept of Shalya Tantra
申办方类型
Government medical college

研究点 (1)

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