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A study on the effects of drug (2% diltiazem) and surgical procedure (lateral internal sphincterotomy) for chronic anal fissure

A comparative study of chemical sphincterotomy (using 2% diltiazem) and lateral internal sphincterotomy for chronic anal fissure: open label randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040119
Enrollment
128
Registered
2022-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: LATERAL INTERNAL SPHINCTEROTOMY: IT IS A SURGICAL PROCEDURE DONE FOR CHRONIC ANAL FISSURE.A 1 TO 2 CM CIRCUMFERENTIAL INCISION WILL BE MADE OVER THE FREE EDGE OF THE INTERNAL SPHINCTER.

Sponsors

Dr Nitin Sherkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)ALL PATIENTS WHO WILL PRESENT IN SURGICAL OUT-PATIENT DEPARTMENT WITH COMPLAINTS OF PAINFUL PASSAGE OF STOOL, WITH OR WITHOUT BLEEDING OF MORE THAN 6 WEEKS DURATION, DIAGNOSED TO BE HAVING CHRONIC ANAL FISSURE BASED ON THE HISTORY AND ON CLINICAL EXAMINATION. b)ALL PREVIOUSLY DIAGNOSED CASES OF ACUTE ANAL FISSURE WHO ARE TAKING STOOL SOFTENER AND MEDICATIONS FOR MORE THAN 6 WEEKS

Exclusion criteria

Exclusion criteria: PATIENTS OF CHRONIC ANAL FISSURE ASSOCIATED WITH a)TUBERCULOSIS b)HAEMORRHOIDS c)ANORECTAL ABSCESSES d)ANAL MALIGNANCIES e)IMMUNOCOMPROMISED PATIENTS f) PREVIOUS HISTORY OF FAECAL INCONTINENCE OR ANAL STENOSIS g) PATIENTS WHO HAVE UNDERGONE PREVIOUS ANAL SURGERIES h)PATIENTS WITH HISTORY OF BLEEDING

Design outcomes

Primary

MeasureTime frame
a) PAIN RELIEF b) BLEEDING c) FECAL INCONTINENCE d) COMPLETE HEALING e) QUALITY OF LIFE f) MEAN MANOMETRY RESTING PRESSURE(MRP) g) MEAN MANOMETRY SQEEZING PRESSURE(MSP)Timepoint: 1 YEAR

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Nitin Sherkar

All India Institute of Medical Sciences, Nagpur

drnitinsherkar123@gmail.com9665223852

Outcome results

None listed

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