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临床试验/NCT05640375
NCT05640375已完成1 期

Comparison of Follow-up and Steroid Treatment Results in Intussusception in Children

Baskent University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2019年12月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
92
试验地点
1
主要终点
Treatment of intussusception

研究概览

简要总结

Treatment interventions in the treatment of intussusception are hydrostatic or pneumatic reduction and manual reduction with laparotomy. In addition, it is known that in some of the ileoileal intussusception cases, intussusception disappears in short-term observation and it is an accepted treatment to follow-up for a while in ileoileal cases without making a decision for laparotomy. In a study the investigators conducted, they reported that 17 of 81 patients had spontaneous opening with follow-up and no further treatment was required. The hydrostatic or pneumatic reduction has a 0.8% risk of bowel perforation, fever due to bacterial translocation is common, septicemia has also been reported and anal fissures due to catheterization is seen. Baby or child's stress, psychology, abdominal pain are other negative aspects that cannot be measured. In a study that was reported a patient with HSP was diagnosed with intussusception while under steroid treatment, and when the patient was taken to laparoscopy, it was observed that the patient's intussusception was opened. In the same study, the authors mentioned that they followed up 4 patients diagnosed with HSP by administering only steroid treatment and observed that intussusception was opened in 3 of these patients without the need for any other intervention.

The steroid is used as a single dose (1 mg/kg) in cases such as acute allergic reactions, bronchiolitis, asthma, laryngitis, edema treatment, bronchoscopy, intubation, extubation medication. When the literature is reviewed, it has been shown that single-dose, low-amount (1 mg/kg) steroid therapy does not have side effects. The investigators predict that the steroid will reduce the thickening of Peyer's plaques with its anti-inflammatory effect, and relieve edema as in other areas of use, by relieving the congested intussusceptum. Thus, in infants and children, there will be no need for hydrostatic or pneumatic reduction, which has the risk of perforation and infection (septicemia) and exposure to radiation, and our patients will regain their health without the need to apply this interventional treatment.

详细描述

Treatment interventions in the treatment of intussusception are hydrostatic or pneumatic reduction and manual reduction with laparotomy. In addition, it is known that in some of the ileoileal intussusception cases that cannot be reached with hydrostatic or pneumatic reduction, intussusception disappears in short-term observation and control ultrasound (USG), and it is an accepted treatment to follow-up for a while in ileoileal cases without making a decision for laparotomy. In a study the investigators conducted, they reported that 17 of 81 patients had spontaneous opening with follow-up and no further treatment was required.

In hydrostatic or pneumatic reduction, a catheter is inserted into the rectum from the anus of the infant or child patient, and the catheter balloon is inflated in a way that does not allow liquid or gas escape. Afterwards, barium, saline (SF) or air is given through this probe with limited pressure (limited pressure is given due to the risk of bowel perforation), the patient is tried to be kept still and an image is taken under fluoroscopy, or if there is an experienced radiologist, SF is given, followed by USG. This procedure has a 0.8% risk of bowel perforation. At the same time, fever due to bacterial translocation is common, septicemia has also been reported. Anal fissures due to catheterization are tried to be treated with warm water pad application after the procedure. Since the follow-up of the procedure is carried out under the scope, the patients are also exposed to radiation. Baby or child's stress, psychology, abdominal pain are other negative aspects that cannot be measured.

As another treatment, surgery includes negative effects such as leaving a scar on the skin, exposing the patient to the risk of adhesion and intestinal obstruction due to adhesion, risk of anesthesia as a surgical procedure, and risk of bleeding and infection.

In a study that was reported a patient with HSP was diagnosed with intussusception while under steroid treatment, and when the patient was taken to laparoscopy, it was observed that the patient's intussusception was opened. In the same study, the authors mentioned that they followed up 4 patients diagnosed with HSP by administering only steroid treatment and observed that intussusception was opened in 3 of these patients without the need for any other intervention. In another study a case of intussusception that recurred 9 times was reported and after investigating the underlying cause, the authors found that the only cause was lymphoid hyperplasia, and they reported that intussusception did not recur after steroid treatment was applied to this patient. . In another study, the authors did not detect any cause other than lymphoid hyperplasia in two cases with recurrent intussusception and that success was achieved with steroid treatment. Although it has been reported that the use of steroid therapy together with hydrostatic or pneumatic reduction causes recurrence at a lower rate than the patients who received only hydrostatic or pneumatic reduction therapy, a study found no difference in this direction.

95% of intussusceptions are idiopathic. In these patients, intussusception is thought to be caused by Peyer's plaques (lymphoid tissue in the intestinal wall) thickened in response to an infection. The increase in the frequency of intussusception after rotavirus vaccine supports this idea.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • who applied to Başkent University Ankara Hospital Pediatric Emergency Polyclinic,
  • Diagnosed with intussusception by USG,
  • Consulted with Pediatric Surgery
  • Informed consent was obtained by explaining treatment options to their families.

排除标准

  • Diffuse tenderness and defense on abdominal examination,
  • The duration of the complaints exceeds 24 hours,
  • When the intestinal blood supply is decreased in the ultrasound findings,
  • Patients with free air on the standing abdominal X-ray,
  • Patients with pathology requiring urgent surgical intervention

研究组 & 干预措施

Single dose Steroid treatment

Experimental

Intussuception diagnosed, Informed consent was obtained by explaining treatment options to their families, no tenderness on abdominal examination, the duration of complaints is less than 24 hours, no findings of complication, Methylprednisolone 1 mg/ kg single dose was given and ultrasonography is repeated 4 hours later (clinical and physical examination findings are monitored)

干预措施: Methylprednisolone (Drug)

结局指标

主要结局

Treatment of intussusception

时间窗: 4 hours later

Ratio of Participants with No intussusception on ultrasonography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba Acer Demir

Clinical Associate Professor

Baskent University

研究点 (1)

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