NCT Number: NCT07016919
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.
Interested in participating?
Request Info6 year–14 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, Pakistan
Location status: Recruiting
Dr Muhammad Ali Sheikh
CONTACT
Dr Noor Ulain
PRINCIPAL_INVESTIGATOR
Shaikh Zayed federal postgraduate medical institute Lahore
CONTACT
04299230293 ext. 2205/2330
All patients presenting to the department of paediatric surgery sheikh Zayed hospital with diagnosis of acute appendicitis fulfilling the inclusion criteria will be enrolled. Informed written consent will be taken from the patient's guardian or parent. Patients will be divided into two groups: group A Interventional group (early enteral nutrition) and group B control group (Conventional enteral nutrition). Both groups would be kept nothing per oral as per management of acute appendicitis. Pre-op antibiotic (injection ceftriaxone 50mg/kg/day) would be given. Patient would be kept pain free by using non opioid analgesics. Open appendectomy will be performed. The patients in group A will be given early enteral nutrition within 6hours after recovery from anesthesia and the patients in group B will be managed according to conventional perioperative management protocol of starting enteral nutrition 24hours post surgery. Data will be collected by the researcher along with the recording of results.Quantitative variables of the study would be length of hospital stay,time for the passage of stool and flatus after surgery and qualitative variables would be nausea, vomiting, diarrhea, abdominal distension,nasogatric tube insertion and readmission to hospital within 1week. All information will be collected through predesigned questionnaire. Data will be analyzed using Statistical Package for social sciences (IBM SPSS Statistics for windows,version 26.0).Data for age, hospital stay,time for the passage of flatus and stool will be described using mean±SD if normally distributed and median(IQR) otherwise.Comparison between groups will be made by using independent sample T-test or MannWhitney U test depending on normality of data. Data for qualitative measures like gender,nausea, vomiting, diarrhea, abdominal distension,NG tube insertion and readmission requirement will be described using frequency and percentages. Comparison among groups will be made by using Chi-square of Fisher-exact test depending on frequencies. P-value ≤ 0.05 will be considered statistically significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral nutrition started within 6hours after paediatric open appendectomy
Oral nutrition started within 24hours after paediatric open appendectomy
Time frame: From enrollment until discharge from hospital (1-7days)
Number of days from the day of surgery until the date of discharge (1-7days)
Time frame: From enrollment until 1week after discharge on follow up
Complications such as nausea, vomiting, abdominal distension and diarrhea associated with early enteral nutrition are observed
Time frame: From enrollment until discharge from hospital (1-7days)
Time to return of bowel activity after surgery assessed by passage of flatus and stool
Contact information is provided by the study sponsor or research team.
Dr Muhammad Sooban Qamar
CONTACT
Dr Noor Ulain
CONTACT
Shaikh Zayed Hospital, Lahore
Other
Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open appendectomy-a Randomised Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
