CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,562 enrolled
Drug / intervention
Fluoroscopic-guided air-enema reduction (FGAR)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06365333
NCT06365333N/ACompleted

Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study In An Ultrahigh Volume Center

National Children's Hospital, Vietnam·observational·Posted Apr 15, 2024·Updated Apr 15, 2024

In Brief

An observational study evaluating Fluoroscopic-guided air-enema reduction (FGAR) for Intussusception. Completed, enrolled 3,562 participants across 2 sites.

Detailed Summary

In pediatric patients, intussusception predominantly occurs in the ileocecal region, with over 90% of cases lacking identifiable causative factors, initiating through peristalsis-driven invagination of bowel segments leading to compromised blood flow and subsequent bowel edema. Persistent obstruction may progress to bowel ischemia and infarction. Vietnam exhibits a higher incidence of intussusception compared to other countries, albeit with similar clinical presentations and anatomical locations, hinting at shared pathophysiology. Despite evidence supporting the safety and efficacy of non-surgical reduction techniques, many medical centers in low- to middle-income countries (LMICs) have not adopted these methods, resulting in unnecessary surgical interventions. The Vietnam National Hospital of Pediatrics (NCH) has employed air enema reduction since the early 2000s but lacks a comprehensive study on fluoroscopic-guided air-enema reduction (FGAR) techniques or success rates. Thus, this study aims to evaluate the long-term outcomes of pneumatic reduction for intussusception at NCH, a high-volume institution in a lower-middle-income country.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsIntussusception
CountriesVietnam

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 15, 2024
Enrollment StartJan 1, 2016
Primary CompletionDec 1, 2017
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 2.2 years ago

Interventions

Fluoroscopic-guided air-enema reduction (FGAR)procedure

A hand-held pump facilitated the delivery of atmospheric air, while pressure was monitored using a digital gauge. A two-way Foley's balloon catheter, ranging from 18oF to 24oF in diameter depending on age, was inserted rectally to introduce air. Following insertion, the balloon was filled with 10cc of saline to prevent air leakage, with patient immobilization ensured by leg straps and hand positioning above the head for abdominal exposure. Under intermittent fluoroscopy, the surgeon operated the pump with the right hand, inflating the catheter to 80 to 120 mmHg, simultaneously palpating the intussusceptum with the left hand, employing a deep gliding motion for deep and fixed cases. Successful reduction, indicated by air entry into the small bowel, was confirmed under fluoroscopy, with a subsequent brief rotating abdominal massage ensuring uniform air distribution throughout the small intestine, confirming complete reduction.