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Completed

NCT Number: NCT06365333

Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study

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.

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Key information

Conditions

Intussusception Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

2 month–30 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The National Hospital of Pediatrics, Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Complicated intussusception

    Time frame: through study completion (2 years)

    Complications, including bowel perforation, occurred during FGAR

  2. ICU admission

    Time frame: through study completion (2 years)

    Clinically unstable patients post-FGAR that required ICU admission

  3. Death

    Time frame: through study completion (2 years)

    Mortality or severe morbidity noted post-FGAR

  4. Failed FGAR

    Time frame: through study completion (2 years)

    Unsuccessful reduction that requires transition to surgical intervention

  5. Recurrence

    Time frame: through study completion (2 years)

    Recurrence of intussusception during the follow-up period

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Collaborators

  • Vinmec Research Institute of Stem Cell and Gene Technology

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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