Clinical trial NCT07016919: Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open Appendectomy
Official title: Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open appendectomy-a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uncomplicated Acute Appendicitis in Children
Lead sponsor: Shaikh Zayed Hospital, Lahore
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 6-14years
* Both male\& female
* Uncomplicated appendicitis(no perforation/gangrene)
* patients who underwent open appendectomy
* ASA grade 1 only
* willing to participate and follow up

Exclusion Criteria:

* 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
* prolonged surgery(anesthesia time\>3hours)
* complicated appendicitis (gangrene, perforation,intra-abdominal abscess)
* post-op shock
* ongoing infection
* GI dysfunction such as gastroesophageal reflux disease/obstruction.

Primary outcomes:
measure: Length of hospital stay
timeFrame: From enrollment until discharge from hospital (1-7days)
Secondary outcomes:
measure: Complications associated with early enteral nutrition
timeFrame: From enrollment until 1week after discharge on follow up
measure: Time to return of bowel activity
timeFrame: From enrollment until discharge from hospital (1-7days)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed federal postgraduate medical institute Lahore
state: Punjab
Study officials:
affiliation: Shaikh Zayed Hospital, Lahore
name: Dr Muhammad Ali sheikh
role: STUDY_DIRECTOR
References:
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