Clinical trial

Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: A Randomized Control Trial (PEGASIS Trial)

Name

IEC/AIIMS BBSR/PG Thesis/

Description

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 regarding the efficacy of PEG alone vs lactulose combined with isabgol used as stool softeners, frequently used for relieving acute constipation in an acute fissure in ano. Hence a good quality randomised study to compare both efficacies is the need of the hour.

Trial arms

Trial start

2022-05-27

Estimated PCD

2023-07-20

Trial end

2023-07-22

Status

Completed

Phase

Early phase I

Treatment

Polyethylene Glycol

Patients will be advised Anobliss (lidocaine with nifedipine) ointment for local application in the anal canal for one month for relief of pain and anal sphincter spasm. Polyethylene glycol syrup at a dose of 15-30 ml will be used for 2 weeks for relief of acute constipation. Patients will be assessed at 1 week and 1 month and evaluated for primary and secondary outcomes.

Arms:

Study group 1(Polyethylene Glycol)

Other names:

Freego PEG oral solution from Alembic Pharmaceuticals Ltd.

Isabgol + Lactulose

Patients will be advised Anobliss (lidocaine with nifedipine) ointment for local application in the anal canal for one month for relief of pain and anal sphincter spasm. Isabgol husk at a dose of 2 teaspoons in 200 ml of warm water before bedtime and 30 ml of syrup lactulose at bedtime will be used for 2 weeks for relief of acute constipation. Patients will be assessed at 1 week and 1 month and evaluated for primary and secondary outcomes.

Arms:

Study group 2 (Isabgol and Lactulose)

Other names:

Duphalac oral solution from Abbott

Size

144

Primary endpoint

Time taken for the resolution of acute pain following fissure in ano.

30 days

Eligibility criteria

Inclusion Criteria: * All patients presenting with acute fissure in ano between the age group of 18 to 75 years. Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 144, 'type': 'ACTUAL'}}

Updated at

2023-07-25

1 organization

2 products

2 indications

Organization

All India Institute of Medical Sciences Bhubaneswar

Product

Indication

Indication

Product