The Impact of Preoperative Supplementation of Zinc

February 8, 2024 updated by: Hoda Atef Abdelsattar Ibrahim, Cairo University

The Impact of Preoperative Supplementation of Zinc on Post-operative Outcomes in Children Undergoing Elective Surgery for Hirsch Sprung Disease

  1. Pre operative anthropometric assessment including : weight in kg, height/length and BMI
  2. Pre operative Zinc supplementation (dose according to the age) for 7 days preoperatively for cases
  3. Postoperative data collection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative data collection :

  • Length of hospital stay
  • Complication and sorting of them
  • Lab withdrawal of inflammatory markers on 2-3 day postoperatively

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Hoda Atef Abdelsattar Ibrahim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. All children patients with Hirschsprung disease admitted for surgical intervention with different ( age , sex )
  2. Type of surgery : transanal pull through
  3. Whose parents or caregivers approve for the participation in the study

Exclusion Criteria:

  1. Patients with emergency situations
  2. Whose parents or caregivers will not apply for the participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
25 children diagnosed with Hirschsprung disease and planned for elective surgery will be supplemented with Zinc 7 days before the operation . Outcomes will be evaluated thorugh measuring the hospital length stay. Other parameters including inflammatory markers as CRP , CRP /albumin ratio and development of postoperative complications will be assesed and compared between cases and controls
Dietary supplement: Zinc
Zinc Supplementation
No Intervention: Control
25 children diagnosed with Hirschsprung disease and planned for elective surgery will recieve the standard care provided for the cases and will not be supplemented with Zinc . Outcomes will be evaluated thorugh measuring the hospital length. Other parameters including inflammatory markers as CRP , CRP /albumin ratio and development of postoperative complications will be assesed and compared between cases and controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of preoerative Zinc supplementation on the hospital length stay in children operated for Hirschsprung's disease
Time Frame: zinc supplemenation for one week
Children oprated for elective surgery for Hirschsprung's disease will be supplemented with zinc seven days before surgery and postoperative data as the duration of hospital length stay in hours will be meausred in both the cases and control groups and comapred.
zinc supplemenation for one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 2, 2023

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 277-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonoymus data can be reproduced

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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