Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:

NCT04486300 | Completed DMC

• 1 other identifier: 100500323
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intussusception

Keywords

Intussusception, Pediatric surgery, Pneumoreduction

Outcome Measures

Primary Outcomes (1)

• Time of presentation

  Seasons with high presented cases

  2 years

Secondary Outcomes (1)

• Surgery

  2 Years

Study Arms (2)

Season of presentation

NO INTERVENTION

Comparison of number of presented cases in each season

Intervention

ACTIVE COMPARATOR

Surgical intervention of failed Pneumatic cases is done

Procedure: Pneumatic reduction and Laparotomy

Interventions

Pneumatic reduction and Laparotomy PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Other concomitant disease.
• Refused cases

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Intussusception

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Surgery

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 24, 2020
• Study Start: January 14, 2014
• Primary Completion: December 13, 2018
• Study Completion: March 7, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: data will be available for 10 years
• Access Criteria: open Access Journal