Which Minimal Invasive Ksharasutra Technique is best in the management of Bhagandhara?

Phase 2/3

Not yet recruiting

• Conditions: Anal fistula. Ayurveda Condition: BHAGANDHAR, (2) ICD-10 Condition: K603||Anal fistula, (3) ICD-10 Condition: K603||Anal fistula. Ayurveda Condition: BAGANDARAH, (4) ICD-10 Condition: K603||Anal fistula. Ayurveda Condition: BAGANDARAH, (5) ICD-10 Condition: K603||Anal fistula. Ayurveda Condition: BAGANDARAH,

• Registration Number: CTRI/2023/06/054472
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-22
• Study Start: 2023-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Duration of Intervention (In minutes)	Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
2. Change in pain score (VAS)	Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
3. Change in discharge score	Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
4. Change in wexner score (Incontinence)	Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period
5. Time taken for wound healing	Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period

Secondary Outcome Measures

Name	Time	Method
1. Length of Hospital stay.	2. Time to return to work.

Trial Locations

Locations (1)

NIA HOSPITAL; 🇮🇳 Jaipur, RAJASTHAN, India

NIA HOSPITAL

🇮🇳Jaipur, RAJASTHAN, India

Satya Santosh Sahoo

Principal investigator

8249967650

sahoosatya63@gmail.com