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CompletedNCT05259670Updated Feb 28, 2022

Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients

An observational study in Intussusception, sponsored by Sanjeev Kharel. Completed at 2 sites in Nepal. Open to participants aged 0 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-02-28.

Sponsored by Sanjeev Kharel · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
0 Years to 16 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Intussusception

Keywords

  • Hydrostatic reduction
  • Recurrence
  • Pediatrics
03

In context

Intussusception

31 studies on the registry are indexed under Intussusception; 6 are open to participants now.

This study's enrollment of 78 is below the median of 250 across 15 observational studies indexed under Intussusception.

Browse Intussusception studies →

Lead sponsor

This is the only study on the registry with Sanjeev Kharel as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Risk factor for recurrent intussusception

    Significant risk factor for recurrent intussusception after successful reduction

    Time frame: June 2019-April 2020

07

Study locations

2 sites
  • Tribhuvan University Teaching hospital
    Kathmandu, Bagmati 4240, Nepal
  • Tribhuvan University Teaching hospital
    Maharajgunj, Bagmati 4240, Nepal
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Apr 2020, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2022
First posted
Feb 28, 2022
StartActual
Jun 1, 2019
Primary completionActual
Apr 1, 2020
CompletionActual
Apr 1, 2020
Last update
Feb 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05259670
Lead sponsor
Sanjeev Kharel
Collaborators
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Responsible party
Sanjeev Kharel (Sponsor investigator, Nepal Medical Student Society) — Sponsor-investigator
First posted
Feb 28, 2022
Start date
Jun 1, 2019
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Feb 28, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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