Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open Appendectomy

NCT ID: NCT07016919

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2025-10-31

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.

Conditions

Uncomplicated Acute Appendicitis in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Interventional group) early enteral nutrition

Oral nutrition started within 6hours after surgery (paediatric open appendectomy) to this group

Group Type: EXPERIMENTAL

early enteral nutrition

Intervention Type: OTHER

Oral nutrition started within 6hours after paediatric open appendectomy

Group B Conventional enteral nutrition

Oral nutrition is started to this group after 24hours of the surgery (open appendectomy)

Group Type: ACTIVE_COMPARATOR

Conventional enteral nutrition

Intervention Type: OTHER

Oral nutrition started within 24hours after paediatric open appendectomy

Interventions

early enteral nutrition

Oral nutrition started within 6hours after paediatric open appendectomy

Intervention Type: OTHER

Conventional enteral nutrition

Oral nutrition started within 24hours after paediatric open appendectomy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaikh Zayed Hospital, Lahore

OTHER

Sponsor Role: lead

Responsible Party

Dr Noor Ulain

Doctor (Resident)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Muhammad Ali sheikh

Role: STUDY_DIRECTOR

Shaikh Zayed Hospital, Lahore

Locations

Shaikh Zayed federal postgraduate medical institute Lahore

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr Noor Ulain

Role: CONTACT

noorulainch2@gmail.com

+92 3064687704

Dr Muhammad Sooban Qamar

Role: CONTACT

soobanqamar@gmail.com

+92 3069783238

Facility Contacts

Shaikh Zayed federal postgraduate medical institute Lahore

Role: primary

SZMCIRB1@gmail.com

04299230293 ext. 2205/2330

Dr Muhammad Ali Sheikh

Role: backup

drali444@yahoo.com

+92 3214790094

References

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Reference Type: BACKGROUND

PMID: 37041392 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 29489656 (View on PubMed)

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Reference Type: BACKGROUND

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Other Identifiers

TERC/SC/INT/2025/360

Identifier Type: -

Identifier Source: org_study_id