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Perioperative Zinc Supplementation and Pediatric Colonic Surgical Recovery

NCT07760493 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-08-12

No results posted yet for this study

Summary

The goal of this randomized controlled clinical trial is to evaluate the role of perioperative zinc supplementation on postoperative outcomes (specifically gastrointestinal mucosal integrity and inflammation) in children aged 1 month to 18 years undergoing elective or semi-urgent colonic surgery with anastomosis.

The main questions it aims to answer are:

* Does perioperative zinc supplementation significantly optimize complete blood count (CBC) parameters, serum C-reactive protein (CRP), and serum zinc levels at 48 hours and 5 days postoperatively?
* Does zinc supplementation improve secondary clinical outcomes, such as wound healing scores on day 7, time to full enteral feeds, and length of hospital stay? Researcher will compare Group A (routine postoperative care plus perioperative zinc supplementation) to Group B (routine postoperative care only) to see if the zinc supplement enhances gut integrity, downregulates systemic inflammation, and reduces postoperative clinical complications.

Participants will:

* Undergo their scheduled elective or semi-urgent colonic surgery with anastomosis.
* Be randomly assigned to receive either routine postoperative care alone or routine care supplemented with perioperative zinc.
* Provide blood samples at baseline (preoperatively), 48 hours postoperatively, and 5 days postoperatively for sequential monitoring of CBC, CRP, and serum zinc levels.
* Undergo clinical and ward assessments during hospitalization until day 7 to monitor clinical parameters (e.g., fever, timing of passage of stool/gases) and wound healing scores.

Conditions

  • Colonic Surgery

Interventions

DRUG

Perioperative Zinc Supplementation

Giving Perioperative Zinc (7 days +/-2 pre-surgery and 7 days +/- 2 post-surgery)

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Noha A. Hamdy, Associate Professor · Faculty of Pharmacy, Alexandria University

  • Zeina A. Taha, Bachelor · Faculty of Pharmacy, Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-01
Completion
2028-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760493 on ClinicalTrials.gov