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临床试验/NCT04486300
NCT04486300已完成不适用

Seasonal Variations and Different Treatment Protocols OF Intussusception In Children: Our Center Experience.

Minia University0 个研究点目标入组 470 人开始时间: 2014年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
470
主要终点
Time of presentation

研究概览

简要总结

Background: Intussusception remains a common cause of bowel obstruction in children and results in significant morbidity and mortality if not promptly treated. There is a paucity of prospective studies regarding childhood intussusception. This study describes the seasonal variation and management outcomes of childhood intussusception.

METHODS: This was A prospective study of all patients admitted and treated for childhood intussusception aged < 12 year intussusception from January 2014 to December 2018 was conducted in El-Minia University Pediatric surgery unit. Data about the ages of the patients, sex, clinical presentation, duration of symptoms before presentation, mode of treatment, outcome of treatment, and incidence of recurrence were recorded and analyzed.

详细描述

A prospective study from January 2014 to December 2018 was conducted in 470 cases in El-Minia University Pediatric surgery unit. All pediatric patients (up to 14 years old) hospitalized with diagnosis of bowel intussusception were included in the study. The clinical records included: age, gender, signs, symptoms, and number of any previous episodes of intussusception and their treatment, concomitant pathologies and intolerance, ultrasound data, laboratory parameters and performed treatment.

An ultrasonography was performed when patients presented suspicion symptoms and signs of intussusception, in order to confirm the diagnosis and exclude other causes. Diagnosis was based on the presence of the "target sign" on vertical section on ultrasound images. Collected data included location and diameter of the intussusception, free fluid in abdomen and presence of visible pathological lead point. If diagnosis was confirmed, the management and treatment depended on the patients' situation, in patients complaining of severe dehydration, high grade fever and other signs of septicemia the conservative treatment was contraindicated and direct surgical treatment was performed. For children in good general conditions initial Pneumatic reduction under continuous imaging monitoring using a C-arm device was attempted; if reduction failed or unstable vital signs were observed, enema was discontinued and surgical management was proposed. If intussusception recurrence was observed in the next hours, Pneumatic reduction was performed again whenever possible.

Treatment After fluid and electrolyte correction, Pneumatic reduction was performed by using air through an 18 F urinary catheter applied to the rectum under continuous imaging guidance by C-arm. With child in a supine position, a Foley catheter was introduced in the rectum and maintained by inflating its balloon with 40 ml saline; the buttocks were joined with a band aid in order to avoid leaks. The rectal cannula was connected to Sphygmomanometer inflatable cuff initially about 80 mmHg increasing up to a maximum of 120. The passage of air into the ileum through the ileocecal valve ensures successful reduction. No time limit was imposed on the duration of the procedure; however, cessation of retrograde movement of the intussusception for more than 15 minutes was regarded as a failed attempt. The procedure was repeated 20 minutes later, with a maximum of 3 attempts.

All children were kept under medical supervision, no oral intake was permitted for the following 24 hours and intravenously fluids and antibiotics were given. After 12 to 24 hours ultrasonography was repeated to exclude early recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All patients in the pediatric age group (<14 years).
  • Proved diagnosis of acute intussusception.
  • Completion of patient's data in the medical records.

排除标准

  • Other concomitant disease.
  • Refused cases

结局指标

主要结局

Time of presentation

时间窗: 2 years

Seasons with high presented cases

次要结局

  • Surgery(2 Years)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Ahmed ElSayed A. Moustafa

Associate Professor of Pediatric Surgery

Minia University

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