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We are going to compare the usefulness of disimpaction (relief obstructing stools) in children with constipation with oral laxative (polyethylene glycol)done at home with the same method done in the hospital using the same medicine

Comparison of efficacy of home-based versus hospital-based disimpaction with polyethylene glycol in children with functional constipation: A randomised control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026900
Enrollment
50
Registered
2020-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Home-based versus hospital based disimpaction with polyethylene glycol in children with functional constipation: Children with functional constipation and fecal impaction will be random

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children of 1-18 years satisfying the Rome III criteria for functional constipation and having impacted stools will be considered for inclusion. Impacted stools will be defined by the presence of fecalith on per abdomen examination or hard stools felt on per rectal examination or x-ray abdomen suggestive of loaded colon.

Exclusion criteria

Exclusion criteria: 1.Those children who previously underwent colorectal surgery. 2.Children with organic pathologies such as Hirschsprung disease, spinal cord pathology etc. 3.On prokinetic drugs like prucalopride. 4.Children with constipation not having impacted stools. 5.Refusal of consent to participate

Design outcomes

Primary

MeasureTime frame
i.Successful disimpaction. Will be defined based on which of the three parameters was used to define impaction. Absence of palpable fecolith, hard stools per rectum or x ray abdomen not suggestive of impaction. In hospital-based setting successful disimpaction is said to occur when clear fluid is excreted through the anus.Timepoint: In home-based disimpaction, the success will be assessed on day 7 and in hospital-based disimpaction it will be assessed on day 2 (at the time of discharge)

Secondary

MeasureTime frame
1. Cost: Details of the expenditure(direct and indirect costs) shall be taken into account. 2. Parental satisfaction: All parents will be administered a Treatment satisfaction questionnaire for medication (TSQM) at the end of the study to assess their comfort and satisfaction with the type of disimpaction. Graded on a 5-point Likert scale ranging from extremely satisfied to extremely dissatisfied. Timepoint: In home-based it will be calculated on Day 7 and in hospital-based it will be calculated at the time of discharge from hospital

Countries

India

Contacts

Public ContactDr Srinivas Srinidhi Vadlapudi

Sanjay Gandhi Post Graduate Institute of Medical Sciences,

srinivas.vadlapudi19@gmail.com8004904719

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026