A clinical trial to study the effect of two different methods of surgery, Ksharsutra ligation and Fibrin Glue application for the patients with Fistula in ano.

Integrative Approach Of Management Of Fistula-In-Ano With Ksharsutra Followed By Fibrin Glue-A Randomised Controlled Clinical Trial - FIAKSFG

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019915

Enrollment

Registered

2019-06-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: Fibrin Glue: Fibrin Glue 0.5 ml to 1 ml as per requirment, using single dose to seal the fistulous tract. If the tract failed to heal in first attempt, second or third dose of Fibrin g

Eligibility

Inclusion criteria

Inclusion criteria: 1.Selection of patients will be done irrespective of sex, religeon,ocupation, economic status and education status. 2.The selected patient should have diagnosed as Bhagandara ( Fistula-in-ano ). 3.Singal tract with no ramifications, low anal with tract length upto 5 cm to 7 cm.

Exclusion criteria

Exclusion criteria: 1.Patient suffering from systemic disorders like Tuberculosis, Diabetes Mellitus , Cancer and Immuno-compromised patients. 2.Patient with high anal fistula and more than 7 cm tract length. 3.Patient suffering from carcinoma of rectum, Hbâ??SAg and HIV 4.Patient suffering from ulcerative colitis, crohnâ??s disease and multiple fistula will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra.Timepoint: The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra.	—

Secondary

Measure	Time frame
The subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed by Fibrin Glue..Timepoint: The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete healing of the fistula tract by Fibrin Glue..;The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on upto the complete debridment (i. e till the stage of Shuddhavastha is acheved). After debridment, the fistulous tract will be sealed with Fibrin Glue.There after,the subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed. Timepoint: The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra followed by Fibrin Glue.	—

Measure

Time frame

The subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed by Fibrin Glue..Timepoint: The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete healing of the fistula tract by Fibrin Glue..;The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on upto the complete debridment (i. e till the stage of Shuddhavastha is acheved). After debridment, the fistulous tract will be sealed with Fibrin Glue.There after,the subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed. Timepoint: The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra followed by Fibrin Glue.

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Countries

India

Contacts

Public ContactDr Raut S Y

Government Ayurved College and Hospital, Nagpur

drsyraut@yahoo.co.in9975830051

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026