Status:
COMPLETED
Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Anal Fissure
Constipation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The existing literature stresses the better efficacy of polyethylene glycol (PEG) over other stool softeners like lactulose or isabgol to improve functional constipation. But there is no consensus re...
Detailed Description
Acute fissure in ano is a very common, painful and distressing benign anorectal disorder. It is a linear tear in the anoderm of the distal anal canal most commonly on the posterior midline. They usual...
Eligibility Criteria
Inclusion
- All patients presenting with acute fissure in ano between the age group of 18 to 75 years.
Exclusion
- Pregnancy / lactation
- Patients not giving consent
- Patients not able to understand the nature of the study
- Diabetes mellitus and chronic kidney disease
- Known intolerance to PEG/Lactulose or Isabgol
- Prior enrolment in other study.
- Patient undergoing surgery for Fissure in Ano
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2023
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05341180
Start Date
May 27 2022
End Date
July 22 2023
Last Update
July 25 2023
Active Locations (1)
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1
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, 751019