NCT05341180|CompletedPhase 2/3DMC
Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial
PEGASIS
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Sponsor study identifier
interventional
144
1 country
1
Study Start
May 27, 2022
Actual (reported)Primary Completion
July 20, 2023
Actual (reported)Study Completion
July 22, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 22, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 10, 2022
Actual (reported)April 22, 2022
Actual (reported)May 27, 2022
Actual (reported)July 20, 2023
Actual (reported)July 22, 2023
Actual (reported)Time taken for the resolution of acute pain following fissure in ano.
Pain will be measured by improvement in visual analog scale (VAS) pain score. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 10).
30 days
Improvement in constipation will be assessed by a change in the Bristol stool form scale.
1 week, 1 month
Adverse effects any of PEG or lactulose with isabgol.
1 month
Patient compliance with the medications
1 month
Polyethylene glycol syrup will be used at a dose of 15-30 ml per day for 2 weeks maximum.
Isabgol 2 teaspoons in 200ml of warm water to consume immediately after soaking before bedtime and syrup Lactulose 30 ml at bedtime for 2 weeks.
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.
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019, India
Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD007570. doi: 10.1002/14651858.CD007570.pub2.
Wang HJ, Liang XM, Yu ZL, Zhou LY, Lin SR, Geraint M. A Randomised, Controlled Comparison of Low-Dose Polyethylene Glycol 3350 plus Electrolytes with Ispaghula Husk in the Treatment of Adults with Chronic Functional Constipation. Clin Drug Investig. 2004;24(10):569-76. doi: 10.2165/00044011-200424100-00002.
Prakash Kumar Sasmal, MBBS, MS
Department of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, Odisha, INDIA
144 participants (actual enrollment reported by the registry).
First Submitted
April 10, 2022
First Posted
April 22, 2022
Study Start
May 27, 2022
Actual (reported)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.
Contact the study team to confirm eligibility.
Tomatsu S, Dieter T, Schwartz IV, Sarmient P, Giugliani R, Barrera LA, Guelbert N, Kremer R, Repetto GM, Gutierrez MA, Nishioka T, Serrato OP, Montano AM, Yamaguchi S, Noguchi A. Identification of a common mutation in mucopolysaccharidosis IVA: correlation among genotype, phenotype, and keratan sulfate. J Hum Genet. 2004;49(9):490-494. doi: 10.1007/s10038-004-0178-8. Epub 2004 Aug 11.
Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
Belsey JD, Geraint M, Dixon TA. Systematic review and meta analysis: polyethylene glycol in adults with non-organic constipation. Int J Clin Pract. 2010 Jun;64(7):944-55. doi: 10.1111/j.1742-1241.2010.02397.x.
Primary Completion
July 20, 2023
Actual (reported)Study Completion
July 22, 2023
Actual (reported)Last Updated
July 25, 2023
Record last verified: 2023-07
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