Clinical trial NCT06365333: Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study
Official title: Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study In An Ultrahigh Volume Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intussusception
Keywords: Intussusception
Minimally invasive
Laparoscopic
Pediatric
Air enema
Pneumatic reduction
Lead sponsor: National Children's Hospital, Vietnam
Sponsor class: OTHER
Collaborators: name: Vinmec Research Institute of Stem Cell and Gene Technology
First posted: 2024-04-15
Enrollment: 3562
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients diagnosed with idiopathic intussusception admitted to the National Children's Hospital between January 2016 and December 2017

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, 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.

Eligibility criteria: Inclusion Criteria:

* All 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.
* Fluoroscopy-guided pneumatic reduction was performed with a maximum of three attempts. Patients who did not respond to pneumatic reduction underwent minimally invasive surgical intervention, either laparoscopic reduction or trans-umbilical mini-open reduction.

Exclusion Criteria:

* Patients demonstrating clinical instability characterized by signs of peritonitis or intestinal perforation necessitating conventional laparotomy.
* Patients deemed unsuitable for air enema reduction due to a grossly distended abdomen or compromised cardiopulmonary function.

Primary outcomes:
measure: Complicated intussusception
timeFrame: through study completion (2 years)
measure: ICU admission
timeFrame: through study completion (2 years)
measure: Death
timeFrame: through study completion (2 years)
measure: Failed FGAR
timeFrame: through study completion (2 years)
measure: Recurrence
timeFrame: through study completion (2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: The National Hospital of Pediatrics
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
name: Quang T Nguyen, M.D.
role: PRINCIPAL_INVESTIGATOR
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