Follow-up and Steroid Treatment Results in Intussusception

Intussusception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640375
• Other study ID #: BUTF-TAcerDemir-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 24, 2019
• Est. completion date: December 24, 2027

Study information

• Verified date: December 2022
• Source: Baskent University
• Contact: Tugba Acer-Demir
• Phone: +90 312 203 6868
• Email: tugba_acer[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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 although chronic and high-dose steroid therapy has side effects, single-dose, low-amount (1 mg/kg) steroid therapy does not have side effects. It is seen that this treatment, which is used when necessary in patients presenting to the emergency department, is used alone in HSP patients in patients with intussusception, and in combination with hydrostatic or pneumatic reduction after treatment in recurrent intussusception cases, to prevent recurrence and to reduce the risk of recurrence.

Recently, with the frequent use of USG, the diagnosis of intussusception is made early and in large numbers, and the prognosis of intussusceptions that are caught early is better. When the investigators examined their cases in the last 10 years, the investigators found that 80% of their cases were diagnosed with a complaint period of less than 24 hours.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 24, 2027
• Est. primary completion date: December 24, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 4 Years

Eligibility

Inclusion Criteria:

• who applied to Baskent 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intussusception

Intervention

Drug:
• Methylprednisolone
Single dose, 1 mg/kg

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of intussusception	Ratio of Participants with No intussusception on ultrasonography	4 hours later