An observational study in Intussusception, sponsored by National Children's Hospital, Vietnam. Completed at 2 sites in Vietnam. Open to participants aged 2 Months to 30 Months. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by National Children's Hospital, Vietnam · Observational
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.
In pediatric patients, intussusception primarily occurs in the ileocecal region, with more than 90% of cases lacking identifiable causative factors. The invagination of bowel segments is propelled by peristalsis, leading to compromised blood flow. This venous occlusion precipitates bowel edema, and if the obstruction persists, it can progress to bowel ischemia and infarction. The incidence of intussusception in Vietnam exceeds that of any other country with available data on incidence rates. Despite variations in incidence rates, intussusception's clinical presentation and anatomical location remain largely consistent between Vietnam and other countries, suggesting a common underlying pathophysiology. Many medical centers in low- to middle-income countries (LMICs) have yet to adopt these non-surgical approaches, resulting in unnecessary surgical interventions for a significant portion of patients. At the Vietnam National Hospital of Pediatrics (NCH), air enema reduction has been a standard practice since the early 2000s. Nonetheless, there has been no comprehensive study delineating the technique of fluoroscopic-guided air-enema reduction (FGAR) at NCH, nor assessing its success rate.
31 studies on the registry are indexed under Intussusception; 6 are open to participants now.
This study's enrollment of 3,562 is above the median of 250 across 15 observational studies indexed under Intussusception.
Browse Intussusception studies →National Children's Hospital, Vietnam is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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Pediatric patients diagnosed with idiopathic intussusception admitted to the National Children's Hospital between January 2016 and December 2017
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Exclusion Criteria:
Patients diagnosed with idiopathic intussusception, admitted to the National Children's Hospital between January 2016 and December 2017, exhibiting clinical signs and symptoms consistent with intussusception, and confirmed via ultrasound examination
Procedure: Fluoroscopic-guided air-enema reduction (FGAR)
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.
Complicated intussusception
Complications, including bowel perforation, occurred during FGAR
Time frame: through study completion (2 years)
ICU admission
Clinically unstable patients post-FGAR that required ICU admission
Time frame: through study completion (2 years)
Death
Mortality or severe morbidity noted post-FGAR
Time frame: through study completion (2 years)
Failed FGAR
Unsuccessful reduction that requires transition to surgical intervention
Time frame: through study completion (2 years)
Recurrence
Recurrence of intussusception during the follow-up period
Time frame: through study completion (2 years)
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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National Children's Hospital, Vietnam