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CTRI Number  CTRI/2023/09/057940 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 21/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   compare x-ray fistulography with P J Deshpande technique of xray fistulography. 
Scientific Title of Study   To study accuracy of radiological findings of modification x-ray fistulography (P J Deshpande technique) and conventional x-ray fistulography in fistula in ano 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil kumar yadav 
Designation  Junior Resident 
Affiliation  Institute Of Medical Sciences B.H.U 
Address  Department of Shalya Tantra IMS BHU Varanasi
Sir Sundarlal Hospital IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  07380586169  
Fax    
Email  anilyadav95627@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rahul Sherkhane 
Designation  Professor 
Affiliation  Institute Of Medical Sciences  
Address  Department of shalya Tantra IMS BHU Varanasi
Sir Sundarlal Hospital IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  8233829723  
Fax    
Email  rahulsherkhane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anil Kumar yadav 
Designation  Junior Resident 
Affiliation  Institute Of Medical Sciences B.H.U 
Address  Department of Shalya Tantra IMS BHU Varanas
Sir Sundarlal Hospital IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  7380586169  
Fax    
Email  anilyadav95627@gmail.com  
 
Source of Monetary or Material Support  
Sir Sundarlal Hospital IMS BHU Varanasi  
 
Primary Sponsor  
Name  Institute Of Medical Sciences 
Address  Department of Shalya Tantra IMS BHU Varanasi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRAnil Kumar Yadav  Sir Sundarlal Hospital BHU Varanasi  OPD 12,14,16,Nrc and Radiology Department of shalyatantra sir sundar lal hospital indian medicine wing bhu varanasi
Varanasi
UTTAR PRADESH 
07380586169

anilyadav95627@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B||Imaging. Ayurveda Condition: Bhagandara, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-conventional x ray fistulography in fistula in ano30 dagnosed patient of fistula in ano on the basis of clinical examination
2Intervention ArmProcedure-Modified X ray Fistulography (PJ Deshpande technique) (Procedure Reference: , Procedure details: Modified X ray Fistulography (PJ Deshpande technique))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients aged between 18 to 70 years with clinical diagnosis of perianal fistula 
 
ExclusionCriteria 
Details  Pregnancy
Fistula in ano with Active cancer of the anorectum
Known case of hypersensitivity to dye
Fistula in ano in immunocompromised patients.
Known cases of secondary fistula
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Modified x ray Fistulography P J Deshpande technique will be better than conventional x ray fistulography.   at Base line only, Zero day 
 
Secondary Outcome  
Outcome  TimePoints 
): In fistula in ano, radiological findings of Modified X ray fistulography (P J Deshpnde technique) are more accurate than radiological findings of conventional X-ray fistulography  7 Dyas 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/10/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Fistula in ano, commonly encountered conditions, is an abnormal tract communicating between the anal canal and perianal skin.  These tracts are filled with granulation tissue and are surrounded by thick fibrous tissue. 90 percent of fistulas are of cryptoglandular origin with the internal orifice in the anal canal, at the level of the anal gland crypt. In 10% of the cases, fistulae are a manifestation of Crohn’s disease, tuberculosis, fungal infection, tumor, or trauma, which are usually complex in nature. It is a chronic and potentially debilitating problem due to repeated pus discharge from external openings in addition to pain, itching, and perianal swelling. Rarely, there can be systemic spread of these infections, incapacitating the individual. In Ayurveda, disease with similar clinical features is described called as bhagandara and this disease is considered as one the grave disease among mentioned eight grave diseases.

Most of these anal fistulae are easy to diagnose with history taking and physical examination. In 48% of cases, but as surgery is the mainstay for treatment of fistula-in-ano. Inadequate excision leads to frequent recurrences and over-excision may lead to sphincter incontinence.  Therefore, accurate and detailed preoperative assessment plays a vital role in the treatment planning and outcome. There are three main radiological imaging techniques in perianal fistulas which are essential in the evaluation of the fistula extent, type of tissues involved and presence of additional inflammatory or purulent foci, location of external and internal openings of the fistula, and the course of the main canal and potential additional branches. They include: contrast fistulography, endorectal ultrasonography and magnetic resonance imaging 

Fistulography is a good diagnostic method for detecting the internal opening in a fistula-in-ano, and it is still used in spite of the introduction of newer, more informative methods.  It is simple and affordable procedure which can be done in an outpatient clinic.  In this technique, the external opening is cannulated with a small-caliber tube and contrast material is injected under minimal pressure while films are taken in several projections. X-ray fistulography may be useful in identifying unsuspected pathology, planning surgical management, and demonstrating anatomic relationships, the sensitivity of that method, according to different authors, ranges from 24% to 50%, however this technique gradually lost its diagnostic value due to non-visualisation of additional branches and anorectal sphincter complex. Now days MR imaging is choice among imaging techniques due to its higher specificity and sensitivity in detection of fistulous tract but its availability in remote areas making difficult for anorectal surgeon to adopt it and overall MR fistulography  highly expensive as compared to other imaging technique.

 

 
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