NCT05785013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

March 2, 2023

Last Update Submit

February 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    zinc supplemenation for one week

Study Arms (2)

Interventional

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

ZincDIETARY_SUPPLEMENT

Zinc Supplementation

Interventional

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoda Atef Abdelsattar Ibrahim

Cairo, Egypt

Location

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Zinc

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatrics

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 27, 2023

Study Start

April 1, 2023

Primary Completion

June 30, 2023

Study Completion

July 2, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Anonoymus data can be reproduced

Locations