NCT05259670

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

February 16, 2022

Last Update Submit

February 24, 2022

Conditions

Keywords

Hydrostatic reductionRecurrencePediatrics

Outcome Measures

Primary Outcomes (1)

  • Risk factor for recurrent intussusception

    Significant risk factor for recurrent intussusception after successful reduction

    June 2019-April 2020

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tribhuvan University Teaching hospital

Kathmandu, Bagmati, 4240, Nepal

Location

Tribhuvan University Teaching hospital

Maharajgunj, Bagmati, 4240, Nepal

Location

MeSH Terms

Conditions

IntussusceptionRecurrence

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor investigator

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 28, 2022

Study Start

June 1, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations