Pediatric GI Endoscopy at Assiut University

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University

About this trial

1. To evaluate the diagnostic role, and outcomes of upper and lower gastrointestinal (GI) endoscopy in identifying gastrointestinal disorders among infants and pediatric patients attending Assiut University Children Hospital. 2. To determine which pediatric patients require endoscopy as part of the diagnostic process. 3. To assess the safety and effectiveness of endoscopic procedures in the detection and management of various gastrointestinal disorders among pediatric patients at Assiut University Children Hospital.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged from 1day to 18 years undergoing diagnostic endoscopy.

Disqualifiers

Incomplete patient data.

Patients undergoing follow-up procedures.

Trial population

Children admitted to Assiut University Children Hospital who present with gastrointestinal symptoms (such as abdominal pain, vomiting, hematemesis, melena, diarrhea, or unexplained anemia) and are referred for diagnostic gastrointestinal endoscopy as part of their clinical evaluation.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Gastrointestinal Endoscopy

    Procedure/Surgery

    Children undergoing evaluation for gastrointestinal symptoms (such as abdominal pain, bleeding, vomiting, chronic diarrhea, suspected foreign body ingestion, or growth failure) will undergo diagnostic gastrointestinal endoscopy (upper or lower as clinically indicated). The procedure will be performed under appropriate sedation/anesthesia using a standard pediatric endoscope. During endoscopy, visualization of the mucosa will be carried out, and biopsies may be taken if needed for histopathological examination.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Diagnostic yield of gastrointestinal endoscopy

Proportion (%) of pediatric patients in whom gastrointestinal endoscopy provides a definitive diagnosis based on endoscopic and histopathological findings.

Time frame
Within 30 days after endoscopy.
2

Distribution of clinical indications for pediatric endoscopy

Proportion (%) of children undergoing endoscopy for each indication (e.g., abdominal pain, GI bleeding, chronic diarrhea).

Time frame
At the time of endoscopy.
3

Correlation between clinical suspicion and confirmed diagnosis

Level of agreement between pre-procedure clinical suspicion and final diagnosis based on endoscopic and histopathological findings (reported as percentage concordance).

Time frame
Within 30 days after endoscopy.

Secondary outcomes

1

Types and frequencies of gastrointestinal disorders diagnosed by endoscopy

Frequency distribution of gastrointestinal disorders diagnosed in pediatric patients undergoing endoscopy.

Time frame
Within 30 days after endoscopy.
2

Safety and complication rates of pediatric endoscopy

Incidence (%) of procedure-related complications (e.g., bleeding, perforation, infection).

Time frame
From the time of endoscopy until 7 days post-procedure.
3

change in awareness among healthcare providers

Change in awareness and knowledge about pediatric gastrointestinal endoscopy, assessed by structured questionnaire score before and after educational sessions.

Time frame
Up to 6 months from start of study.

Other outcomes

Sponsors and contacts

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