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临床试验/NCT06351163
NCT06351163已完成不适用

Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study on the Long-Term Outcome

National Children's Hospital, Vietnam2 个研究点 分布在 1 个国家目标入组 181 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
181
试验地点
2
主要终点
Long-term complication rate

研究概览

简要总结

Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients.

详细描述

Intussusception, the leading cause of intestinal obstruction in children aged 3 months to 5 years, significantly impacts morbidity and mortality rates. Most cases involve the ileocolic region and are typically amenable to resolution via air enema, achieving success rates of up to 95%. Surgical intervention becomes necessary in cases where pneumatic reduction fails or is contraindicated. Historically, the manual reduction required a substantial right-sided transverse incision. However, the advancement of minimally invasive approaches in pediatric surgery, particularly the laparoscopic approach (LAP), has gained traction in managing intussusception. LAP offers the advantages of decreased surgical trauma and shorter operative durations compared to open procedures. Nevertheless, the adoption of laparoscopic intervention for intussusception remains contentious due to challenges such as limited operative space in pediatric patients and variability in the affected bowel segment, impeding widespread acceptance. This study aims to investigate the safety and feasibility of laparoscopic (LAP) and mini-open reduction (MOR) techniques in managing idiopathic intussusception in pediatric patients.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with idiopathic intussusception, admitted to the National Children's Hospital between January 2016 and December 2020, exhibiting clinical signs and symptoms consistent with intussusception, and confirmed by ultrasound.
  • Fluoroscopy-guided pneumatic reduction was performed, allowing a maximum of three attempts.
  • Patients unresponsive to pneumatic reduction underwent laparoscopic reduction (LAP).
  • If LAP failed to manage the intussusceptum, conversion to transumbilical mini-open reduction (MOR) was initiated.
  • Patients deemed unsuitable for air enema reduction due to a grossly distended abdomen or compromised cardiopulmonary function, making them unlikely to tolerate pneumoperitoneum, were also directed towards MOR.
  • Patients with a history of previous intussusception episodes requiring reduction.
  • Patients displaying clinical instability with signs of peritonitis or intestinal perforation requiring conventional laparotomy.
  • Patients presenting with pathologic lead points.
  • Patients who had complications, such as perforation, during pneumatic reduction.

排除标准

  • Patients in critical condition or suspected of bowel perforation and peritonitis
  • Patients who did not meet the criteria for air enema reduction due to significant abdominal distension or compromised cardiopulmonary function

结局指标

主要结局

Long-term complication rate

时间窗: through study completion (5 years)

Instances of complications occurred post-operation found on subsequent follow-ups for patients treated with either MOR or LAP

Operating time

时间窗: through study completion (5 years)

The average operating time (minutes) recorded between the two operating techniques (MOR or LAP)

Hospital stays

时间窗: through study completion (5 years)

The average amount of time (days) for the patient to get discharged post-operation (MOR or LAP)

Recurrence rate

时间窗: through study completion (5 years)

Instances when signs or symptoms of intussusception re-occurred after receiving treatment via operation (MOR or LAP)

Intraoperative complications

时间窗: through study completion (5 years)

Instances of complications occurred during both operating techniques (MOR or LAP)

Time to feed

时间窗: through study completion (5 years)

The average amount of time (days) for the patient to tolerate feeding post-operation (MOR or LAP)

Immediate postoperative complications

时间窗: through study completion (5 years)

Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP

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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