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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm (Non Ayurveda) | | - | conventional x ray fistulography in fistula in ano | 30 dagnosed patient of fistula in ano on the basis of clinical examination | 2 | Intervention Arm | Procedure | - | 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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