Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial
Condition: Anal Fissure; Constipation
MeSH terms: Fissure in Ano; Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

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 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.
    

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 usually result from trauma caused by the passage of hard stool and less
      commonly from diarrhoea also. The most common presenting symptom is anal pain, bleeding and
      secondary constipation. Most of the cases are managed conservatively by increasing oral fluid
      intake, high fibre diet, sitz bath, stool softeners and topical application of sphincter
      muscle relaxants.

      Constipation is one of the most common causes of anal fissure. Patients present to the
      outpatient department due to acute anal pain resulting from increased internal anal sphincter
      tone with spasms and hard stool rubbing over the crack. Constipation and pain due to anal
      fissure are initially managed with lifestyle and dietary modifications like consuming
      adequate fluids, increased fibre diet and sitz bath.

      One of the fibre supplements is isabgol husk, a soluble fibre with enormous water-absorbing
      properties. Its added benefits include properties like non-irritant to the large bowel,
      non-fermenting, and dichotomous stool normalising agents, making it one of the most preferred
      bulk-forming agents. Low cost and over the counter availability are other benefits. Lactulose
      is also the most commonly prescribed laxative used in acute anal fissures to relieve
      constipation. Polyethylene glycol is a common osmotic laxative used for the relief of
      constipation in the treatment of anal fissures.

      There are multiple studies that say polyethylene glycol has better efficacy in terms of
      frequency of stools, and form of stools compared to lactulose or isabgol husk alone. However,
      there are no studies conducted to compare the efficacy of polyethylene glycol vs combined use
      of isabgol husk and lactulose in relief of constipation in an acute fissure in ano. However,
      studies prove that laxatives may reduce/delay the absorption of certain medications, hence
      medications are advised to be taken 1 hour before or 2-3 hours after taking laxatives.

      Patients in both arms will be advised to use local lidocaine with nifedipine cream (Anobliss
      cream from Samarth Life Sciences Pvt. Ltd., India). One arm will be given polyethylene glycol
      syrup for 2 weeks maximum and in the other arm, isabgol husk plus lactulose will be given for
      2 weeks. Patients will be assessed at the end of a week, and 1 month and evaluated for
      primary and secondary outcomes.
    

Intervention name(s): Polyethylene Glycol; Isabgol + Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Freego PEG oral solution from Alembic Pharmaceuticals Ltd.; Duphalac oral solution from Abbott
Intervention MeSH terms: Lactulose; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute fissure in ano; Constipation; Lactulose; Isabgol; Polyethylene Glycol