Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients

February 24, 2022 updated by: Sanjeev Kharel

Risk Factors for Recurrent Intussusception After Successful Reduction in Pediatric Patients in a Tertiary Care Hospital of Nepal: A Prospective-Study

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal, 4240
        • Tribhuvan University Teaching Hospital
      • Maharajgunj, Bagmati, Nepal, 4240
        • Tribhuvan University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric population age less than 16 years old recruited undergoing recurrent intussusception with successful reduction followed up for 1 month.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factor for recurrent intussusception
Time Frame: June 2019-April 2020
Significant risk factor for recurrent intussusception after successful reduction
June 2019-April 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanjeev Kharel

Collaborators

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

April 1, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (ACTUAL)

February 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 077/078

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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