The Impact of Preoperative Supplementation of Zinc

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05785013

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Surgery Nutrition Disorders	Dietary Supplement: Zinc	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 2, 2023

Anticipated Study Completion Date :

Jun 2, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoda Atef Abdelsattar Ibrahim, Lecturer of Pediatrics, Cairo University

ClinicalTrials.gov Identifier:

NCT05785013

Other Study ID Numbers:

MS 277-2022

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Nutrition Disorders

Study Results

No Results Posted as of Mar 27, 2023