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Clinical Trials/CTRI/2023/09/057940
CTRI/2023/09/057940Not yet recruitingNot Applicable

To study accuracy of radiological findings of modification x-ray fistulography (P J Deshpande technique) and conventional x-ray fistulography in fistula in ano

Institute Of Medical Sciences1 site in 1 country60 target enrollmentStarted: March 10, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Modified x ray Fistulography P J Deshpande technique will be better than conventional x ray fistulography.

Study Overview

Brief Summary

Fistula in ano, commonlyencountered conditions, is an abnormal tract communicating between the analcanal and perianal skin.  These tractsare filled with granulation tissue and are surrounded by thick fibrous tissue.90 percent of fistulas are of cryptoglandular origin with the internal orificein 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, fungalinfection, tumor, or trauma, which are usually complex in nature. It is a chronicand potentially debilitating problem due to repeated pus discharge fromexternal openings in addition to pain, itching, and perianal swelling. Rarely,there can be systemic spread of these infections, incapacitating theindividual. In Ayurveda, disease with similar clinical features is describedcalled as bhagandara and this disease is considered as one the gravedisease among mentioned eight grave diseases.

Mostof these anal fistulae are easy to diagnose with history taking and physicalexamination. In 48% of cases, but as surgery is the mainstay for treatment offistula-in-ano. Inadequate excision leads to frequent recurrences andover-excision may lead to sphincter incontinence.  Therefore, accurate and detailed preoperativeassessment plays a vital role in the treatment planning and outcome. There arethree main radiological imaging techniques in perianal fistulas which areessential in the evaluation of the fistula extent, type of tissues involved andpresence of additional inflammatory or purulent foci, location of external andinternal openings of the fistula, and the course of the main canal andpotential additional branches. They include: contrast fistulography, endorectalultrasonography and magnetic resonance imaging

Fistulography is a good diagnostic method fordetecting the internal opening in a fistula-in-ano, and it is still used inspite of the introduction of newer, more informative methods.  It is simple and affordable procedure whichcan be done in an outpatient clinic.  Inthis technique, the external opening is cannulated with a small-caliber tubeand contrast material is injected under minimal pressure while films are takenin several projections. X-ray fistulography may be useful in identifyingunsuspected pathology, planning surgical management, and demonstrating anatomicrelationships, the sensitivity of that method,according to different authors, ranges from 24% to 50%, however this techniquegradually lost its diagnostic value due to non-visualisation of additional branches and anorectal sphincter complex. Nowdays MR imaging is choice among imaging techniques due to its higherspecificity and sensitivity in detection of fistulous tract but itsavailability in remote areas making difficult for anorectal surgeon to adopt itand overall MR fistulography  highlyexpensive as compared to other imaging technique.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients aged between 18 to 70 years with clinical diagnosis of perianal fistula.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Modified x ray Fistulography P J Deshpande technique will be better than conventional x ray fistulography.

Time Frame: at Base line only, Zero day

Secondary Outcomes

  • ): 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)

Investigators

Sponsor
Institute Of Medical Sciences
Sponsor Class
Government medical college

Study Sites (1)

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