SurgeryNCT05785013
The Impact of Preoperative Supplementation of Zinc
A study testing Zinc in people with Surgery and Nutrition Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Surgery, Nutrition Disorders
- What is being tested?
- Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 2 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with emergency situations
- Whose parents or caregivers will not apply for the participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Preoperative Supplementation of Zinc on Post-operative Outcomes in Children Undergoing Elective Surgery for Hirsch Sprung Disease
- 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
Read the detailed description
Postoperative data collection :
- Length of hospital stay
- Complication and sorting of them
- Lab withdrawal of inflammatory markers on 2-3 day postoperatively
- Conditions
- Surgery, Nutrition Disorders
- Being tested
- Zinc
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDietary supplement
Zinc Supplementation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: zinc supplemenation for one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Atef Abdelsattar Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785013
- Sponsor's protocol ID
- MS 277-2022
- Status last verified
- Feb 2024
- First submitted
- 2 Mar 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonoymus data can be reproduced
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Supplementation of Zinc on Post-operative Outcomes in Children Undergoing Elective Surgery for Hirsch Sprung Disease
- ClinicalTrials.gov ID
- NCT05785013
- Acronym / sponsor ID
- MS 277-2022
- Conditions
- Surgery, Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Dietary Supplement: Zinc25 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 |
| 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 |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with emergency situations
- Whose parents or caregivers will not apply for the participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincZinc Supplementation | Dietary supplement | Interventional |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No. Anonoymus data can be reproduced
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with Surgery and Nutrition Disorders, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.