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临床试验/NCT06365333
NCT06365333已完成不适用

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

National Children's Hospital, Vietnam2 个研究点 分布在 1 个国家目标入组 3,562 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,562
试验地点
2
主要终点
Death

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Months 至 30 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Death

时间窗: through study completion (2 years)

Mortality or severe morbidity noted post-FGAR

Failed FGAR

时间窗: through study completion (2 years)

Unsuccessful reduction that requires transition to surgical intervention

Complicated intussusception

时间窗: through study completion (2 years)

Complications, including bowel perforation, occurred during FGAR

ICU admission

时间窗: through study completion (2 years)

Clinically unstable patients post-FGAR that required ICU admission

Recurrence

时间窗: through study completion (2 years)

Recurrence of intussusception during the follow-up period

次要结局

未报告次要终点

研究者

发起方
National Children's Hospital, Vietnam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nguyen Thanh Quang

Pediatric Surgeon

National Children's Hospital, Vietnam

研究点 (2)

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