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The Impact of Preoperative Supplementation of Zinc

Primary Purpose

Surgery, Nutrition Disorders

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Zinc
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgery

Eligibility Criteria

1 Month - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All children patients with Hirschsprung disease admitted for surgical intervention with different ( age , sex ) Type of surgery : transanal pull through Whose parents or caregivers approve for the participation in the study Exclusion Criteria: Patients with emergency situations Whose parents or caregivers will not apply for the participation in the study

Sites / Locations

  • Hoda Atef Abdelsattar Ibrahim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

The effect of preoerative Zinc supplementation on the hospital length stay in children operated for Hirschsprung's disease
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2023
Last Updated
August 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05785013
Brief Title
The Impact of Preoperative Supplementation of Zinc
Official Title
The Impact of Preoperative Supplementation of Zinc on Post-operative Outcomes in Children Undergoing Elective Surgery for Hirsch Sprung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pre operative anthropometric assessment including : weight in kg, height/length and BMI Pre operative Zinc supplementation (dose according to the age) for 7 days preoperatively for cases Postoperative data collection
Detailed Description
Postoperative data collection : Length of hospital stay Complication and sorting of them Lab withdrawal of inflammatory markers on 2-3 day postoperatively

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Nutrition Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
Zinc Supplementation
Primary Outcome Measure Information:
Title
The effect of preoerative Zinc supplementation on the hospital length stay in children operated for Hirschsprung's disease
Description
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.
Time Frame
zinc supplemenation for one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All children patients with Hirschsprung disease admitted for surgical intervention with different ( age , sex ) Type of surgery : transanal pull through Whose parents or caregivers approve for the participation in the study Exclusion Criteria: Patients with emergency situations Whose parents or caregivers will not apply for the participation in the study
Facility Information:
Facility Name
Hoda Atef Abdelsattar Ibrahim
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonoymus data can be reproduced

Learn more about this trial

The Impact of Preoperative Supplementation of Zinc

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