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Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open Appendectomy

ConditionUncomplicated Acute Appendicitis in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorShaikh Zayed Hospital, Lahore

About this trial

This clinical trial is conducted to see if after surgery of appendix(open appendectomy) in children giving oral nutrition within 6hours of surgery instead of older method of starting oral nutrition after 24hours of surgery improves the outcome or not which is the length of hospital stay(from the day of surgery until discharge) and to look for complications associated with oral nutrition (nausea, vomiting, abdominal distension, diarrhea) as well as return of bowel activity after surgery that is passage of flatus(gas) and stool.Participants after taking informed consent are enrolled in two groups,group A in which oral nutrition is started in 6hours and group B in which oral nutrition is started after 24hours of surgery and then see for the outcome during hospital stay until 1week after discharge on follow up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 6-14years

Both male& female

Uncomplicated appendicitis(no perforation/gangrene)

patients who underwent open appendectomy

Disqualifiers

Any underlying comorbidities or organ dysfunction for example renal,GI, respiratory, congenital heart disease

severe protein caloric malnourishment or obesity BMI>25

any past surgical history related to gut

any associated malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • early enteral nutrition

    Other intervention

    Oral nutrition started within 6hours after paediatric open appendectomy

  • Conventional enteral nutrition

    Other intervention

    Oral nutrition started within 24hours after paediatric open appendectomy

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Group A (Interventional group) early enteral nutritionExperimental treatment 1 intervention
Group B: Group B Conventional enteral nutritionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay

Number of days from the day of surgery until the date of discharge (1-7days)

Time frame
From enrollment until discharge from hospital (1-7days)

Secondary outcomes

1

Complications associated with early enteral nutrition

Complications such as nausea, vomiting, abdominal distension and diarrhea associated with early enteral nutrition are observed

Time frame
From enrollment until 1week after discharge on follow up
2

Time to return of bowel activity

Time to return of bowel activity after surgery assessed by passage of flatus and stool

Time frame
From enrollment until discharge from hospital (1-7days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shaikh Zayed Hospital, Lahore

Lead sponsor

Source ClinicalTrials.gov
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