Research to study the benefits of additional local antibiotic to conservative therapy for healing of painful cuts in back passage

Not Applicable

Active, not recruiting

• Conditions: Anal fissure, unspecified,

• Registration Number: CTRI/2021/04/032801
• Lead Sponsor: Dr Gopal Krishna

Brief Summary

Anal fissure is one of the most common presenting complaints in the outpatient departments of general surgery. It is a well-recognized cause of acute anal pain. Although the exact pathophysiology is not yet elucidated but subclinical infection is hypothesized to be associated with chronic anal fissure. In previous studies addition of both oral and local antibiotics to conservative management benefited the patients with both acute and chronic anal fissure. 

Hypothesis: addition of local antibiotic to conservative management may hasten and improve recovery rate

Local vasodilator and analgesic or anaesthetic have proven benefits in both acute and chronic anal fissure. To evaluate whether addition of local antibiotic has any added advantage in terms of recovery and patient’s satisfaction this present study is undertaken.



Patients of acute anal fissure were recruited after obtaining informed consent. Randomized as per allocation sequence done. 68 patients are recruited.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-18
• Last Update Posted: 2022-12-04

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• patients with clinical diagnosis of anal fissure 2.
• lesions limited to the epithelium, 3.
• patients who has pain in the anal region together with ulcers 4.
• Ulcer in the posterior anoderm without any skin tags 5.
• Consenting patients willing to voluntarily take part in this study after getting detailed information.

Exclusion Criteria

• Presumed or confirmed pregnancy 2.
• Lactating women 3.
• History of reaction or intolerance to topical agents 4.
• Associated co-morbidity, such as ischemic heart disease, hypertension,chronic obstructive pulmonary disease, diabetes mellitus, inflammatory bowel disease, HIV- related fissure, tuberculosis ulcer and leukemic ulcer; and associated complications warranting surgery (abscess, fistula, haemorrhoids, and cancer).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recovery rate	3rd week and 6th week of treatment

Secondary Outcome Measures

Name	Time	Method
VAS score	1st week, 3rd week and 6th week of starting treatment

Trial Locations

Locations (1)

IGIMS; 🇮🇳 Patna, BIHAR, India

IGIMS

🇮🇳Patna, BIHAR, India

Dr Vivek Kumar Roy

Principal investigator

9801716613

roykanu23@gmail.com