Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365333
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Pneumatic Reduction For Intussusception In Children A Retrospective Cohort Study
Sponsor:
National Childrens Hospital Vietnam
Organization:
National Childrens Hospital Vietnam
Study Overview
Official Title:
Pneumatic Reduction For Intussusception In Children A Retrospective Cohort Study In An Ultrahigh Volume Center
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 intussusceptions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None