ClinicalTrials.gg
RecruitingNCT07016919Updated Jun 15, 2025

Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open Appendectomy

An interventional study of early enteral nutrition and Conventional enteral nutrition in Uncomplicated Acute Appendicitis in Children, sponsored by Shaikh Zayed Hospital, Lahore. Recruiting at 1 site in Pakistan. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Shaikh Zayed Hospital, Lahore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
6 Years to 14 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Uncomplicated Acute Appendicitis in Children

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03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 88 is below the median of 111 across 252 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Shaikh Zayed Hospital, Lahore is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any underlying comorbidities or organ dysfunction for example renal,GI, respiratory, congenital heart disease
  • severe protein caloric malnourishment or obesity >25
  • any past surgical history related to gut
  • any associated
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    Group A (Interventional group) early enteral nutrition

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

    Other: early enteral nutrition

  • Active comparator
    Group B Conventional enteral nutrition

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

    Other: Conventional enteral nutrition

Interventions

  • Otherearly enteral nutrition

    Oral nutrition started within 6hours after paediatric open appendectomy

  • OtherConventional enteral nutrition

    Oral nutrition started within 24hours after paediatric open appendectomy

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What researchers measure

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)

07

Study locations

1 of 1 sites recruiting
  • Shaikh Zayed federal postgraduate medical institute Lahore
    Lahore, Punjab, Pakistan
    Recruiting
    • Shaikh Zayed federal postgraduate medical institute Lahore · ContactSZMCIRB1@gmail.com · 04299230293
    • Dr Muhammad Ali Sheikh · Contactdrali444@yahoo.com · +92 3214790094
    • Dr Noor Ulain · Principal investigator
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References and documents

Publications

  • Zhang SM, Chen J, Li H, Guo MF, Han N, Sun JS, Zhang CF, Su L. Clinical application of enhanced recovery after surgery concept in laparoscopic treatment of pediatric acute appendicitis. Pediatr Surg Int. 2023 Apr 11;39(1):178. doi: 10.1007/s00383-023-05439-5. PubMed 37041392 ↗
  • Mvoula L, Irizarry E. Tolerance to and Postoperative Outcomes With Early Oral Feeding Following Elective Bowel Surgery: A Systematic Review. Cureus. 2023 Aug 4;15(8):e42943. doi: 10.7759/cureus.42943. eCollection 2023 Aug. PubMed 37667705 ↗
  • Ying Y, Xu HZ, Han ML. Enhanced recovery after surgery strategy to shorten perioperative fasting in children undergoing non-gastrointestinal surgery: A prospective study. World J Clin Cases. 2022 Jun 6;10(16):5287-5296. doi: 10.12998/wjcc.v10.i16.5287. PubMed 35812657 ↗
  • Shang Q, Geng Q, Zhang X, Xu H, Guo C. The impact of early enteral nutrition on pediatric patients undergoing gastrointestinal anastomosis a propensity score matching analysis. Medicine (Baltimore). 2018 Mar;97(9):e0045. doi: 10.1097/MD.0000000000010045. PubMed 29489656 ↗
  • Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ. 2001 Oct 6;323(7316):773-6. doi: 10.1136/bmj.323.7316.773. PubMed 11588077 ↗
  • Mahmud GI, Hasan MM, Hakim MH, Rifat NH, Bhuiyan MAR, Islam T, Akter MN, Mithila SR, Mokarram MMB. The Outcome of Early Oral Feeding Following Elective Gastrointestinal Surgery. Cureus. 2024 Jul 4;16(7):e63802. doi: 10.7759/cureus.63802. eCollection 2024 Jul. PubMed 39100012 ↗
  • Farhad T, Sarwar MKA, Chowdhury MZ, Walid A, Sadia A, Chowdhury TK. Fast Track versus Conventional Perioperative Care Protocols in Paediatric Intestinal Stoma Closure - A Randomised Study. Afr J Paediatr Surg. 2024 Apr 1;21(2):123-128. doi: 10.4103/ajps.ajps_100_22. Epub 2023 Apr 10. PubMed 38546251 ↗
  • Gao R, Yang H, Li Y, Meng L, Li Y, Sun B, Zhang G, Yue M, Guo F. Enhanced recovery after surgery in pediatric gastrointestinal surgery. J Int Med Res. 2019 Oct;47(10):4815-4826. doi: 10.1177/0300060519865350. Epub 2019 Aug 4. PubMed 31379230 ↗
  • Al-Taher R, Alshahwan H, Abdelhadi S, Abeeleh FA, Rashdan M, Amarin M, Addasi R, Alsaraireh D, Abu-Shanab A, Alaridah N. Enhanced recovery concepts in paediatric patients who underwent appendectomy: a retrospective cohort study at a tertiary university hospital. J Int Med Res. 2023 Feb;51(2):3000605231158524. doi: 10.1177/03000605231158524. PubMed 36852822 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07016919
Lead sponsor
Shaikh Zayed Hospital, Lahore
Responsible party
Dr Noor Ulain (Doctor (Resident), Shaikh Zayed Hospital, Lahore) — Principal investigator
First posted
Jun 12, 2025
Start date
Mar 20, 2025
Primary completion
Sep 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jun 15, 2025

Study contacts

Dr Noor Ulain
Contact
noorulainch2@gmail.com
+92 3064687704
Dr Muhammad Sooban Qamar
Contact
soobanqamar@gmail.com
+92 3069783238
Dr Muhammad Ali sheikh
study director · Shaikh Zayed Hospital, Lahore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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