A RANDOMIZED CONTROLLED TRIAL TO SEE EFFECTIVENESS OF POLYETHYLENE GLYCOL VERSUS LACTULOSE IN MANAGEMENT OF PEDIATRIC ANAL FISSURE

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250312008

Enrollment

Registered

2025-03-12

Start date

2023-12-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal fissure Constipation Pediatric anal fissure Anal fissure Constipation Pediatrics Laxatives Polyethylene glycol Lactulose Bowel regulation Defecation disorders Pediatric surgery Gastrointestinal diseases

Interventions

Patients in this arm will receive Polyethylene Glycol (0.5 g/kg/day) in two divided doses for 4 weeks to assess its effectiveness in relieving constipation and healing pediatric anal fissures.,Patient

Active Comparator Drug,Active Comparator Drug

Polyethylene Glycol (PEG),Lactulose

Eligibility

Sex/Gender

All

Age

4 Months to 16 Years

Inclusion criteria

Inclusion criteria: 1. Age between 4months to 16years 2. Painful defecation with visible anal fissure 3. Bleeding per rectum (bright red) and streaking 4. Constipation

Exclusion criteria

Exclusion criteria: 1. Painful defecation without visible anal fissure 2. Bloody diarrhea 3. Co-morbidity (e.g. Diverticular disease, rectal polyps, rectal prolapse) 4. Bleeding per rectum (color other than bright red) Refuse to participate

Design outcomes

Primary

Measure	Time frame
Effectiveness of Laxative Treatment 4 weeks Painless defecation with no rectal bleeding (Grade V stool consistency)	—

Secondary

Measure	Time frame
N/A N/A N/A	—

Countries

Pakistan

Contacts

Public ContactUmar Mahmood

University of Child Health Sciences, Lahore

umarmahmud1992@live.com923324741778

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026