Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:

NCT ID: NCT04486300

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-14
• Study Completion Date: 2020-03-07

Brief Summary

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.

Detailed Description

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.

Conditions

Intussusception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Season of presentation

Comparison of number of presented cases in each season

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Surgical intervention of failed Pneumatic cases is done

Group Type: ACTIVE_COMPARATOR

Pneumatic reduction and Laparotomy

Intervention Type: PROCEDURE

Pneumatic reduction is the main intervention for suitable cases and If failed a laparotomy exploration and surgical reduction is done to save life

Interventions

Pneumatic reduction and Laparotomy

Pneumatic reduction is the main intervention for suitable cases and If failed a laparotomy exploration and surgical reduction is done to save life

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Other concomitant disease.
• Refused cases

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ahmed ElSayed A. Moustafa

Associate Professor of Pediatric Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

100500323

Identifier Type: -

Identifier Source: org_study_id