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Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients

Sponsor
Sanjeev Kharel (Other)
Overall Status
Completed
CT.gov ID
NCT05259670
Collaborator
Tribhuvan University Teaching Hospital, Institute Of Medicine. (Other)
78
Enrollment
2
Locations
10
Actual Duration (Months)
39
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine risk factors associated with recurrent intussusception among pediatric patients who have undergone successful reduction at a tertiary care hospital.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is the prospective observational study. In this study, 78 patients,age <16 years with diagnosis of intussusception between June 2019 and April 2020 who had successful reduction with either hydrostatic reduction and/or operative reduction in Teaching Hospital were enrolled in the study. They were followed up to a period of 1 month for recurrence of intussusception. The recurrent cases were thus identified and various variables were compared between recurrent and non-recurrent cases by univariable and multivariable analysis.

    This prospective observational study was approved by the ethics committees of Institutional review board of Tribhuvan University, Institute of Medicine.

    A standard structured questionnaire was filled by interviewing the patient (if possible) and family members/relatives after taking informed written consent. The questionnaire documented the patient's age, sex, weight, duration of symptoms, presenting symptoms: abdominal pain, excessive cry, vomiting, lethargy, blood in stool, fever, palpable mass, constipation, diarrhoea ,location of mass, enlarged lymph nodes(LNs), blood counts and methods of reduction. Age of 2 years, weight of 12 kg and duration of symptoms of 48 hours was used to classify patients into two groups

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    78 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for Recurrent Intussusception After Successful Reduction in Pediatric Patients in a Tertiary Care Hospital of Nepal: A Prospective-Study
    Actual Study Start Date :
    Jun 1, 2019
    Actual Primary Completion Date :
    Apr 1, 2020
    Actual Study Completion Date :
    Apr 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Risk factor for recurrent intussusception [June 2019-April 2020]

      Significant risk factor for recurrent intussusception after successful reduction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • We included the patients who were diagnosed with intussusception from the age of 0 year to 16 years who received nonoperative and operative reduction as an initial treatment.
    Exclusion Criteria:
    • Pediatric patients with spontaneous reduction of hydro-reduction and who required resection and anastomosis as a part of operative procedure were excluded from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tribhuvan University Teaching hospital Kathmandu Bagmati Nepal 4240
    2 Tribhuvan University Teaching hospital Maharajgunj Bagmati Nepal 4240

    Sponsors and Collaborators

    • Sanjeev Kharel
    • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanjeev Kharel, Sponsor investigator, Nepal Medical Student Society
    ClinicalTrials.gov Identifier:
    NCT05259670
    Other Study ID Numbers:
    • 077/078
    First Posted:
    Feb 28, 2022
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sanjeev Kharel, Sponsor investigator, Nepal Medical Student Society
    Hydrostatic reduction
    Recurrence
    Pediatrics
    Additional relevant MeSH terms:
    Intussusception

    Study Results

    No Results Posted as of Feb 28, 2022