NCT07016919

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 1, 2025

Last Update Submit

June 11, 2025

Conditions

Uncomplicated Acute Appendicitis in Children

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

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

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

Secondary Outcomes (2)

  • Complications associated with early enteral nutrition

    From enrollment until 1week after discharge on follow up

  • Time to return of bowel activity

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

Study Arms (2)

Group A (Interventional group) early enteral nutrition

EXPERIMENTAL

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

Other: early enteral nutrition

Group B Conventional enteral nutrition

ACTIVE COMPARATOR

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

Other: Conventional enteral nutrition

Interventions

early enteral nutritionOTHER

Oral nutrition started within 6hours after paediatric open appendectomy

Group A (Interventional group) early enteral nutrition
Conventional enteral nutritionOTHER

Oral nutrition started within 24hours after paediatric open appendectomy

Group B Conventional enteral nutrition

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed federal postgraduate medical institute Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (9)

  • 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.

    PMID: 37041392BACKGROUND

  • 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.

    PMID: 37667705BACKGROUND

  • 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.

    PMID: 35812657BACKGROUND

  • 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.

    PMID: 29489656BACKGROUND

  • 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.

    PMID: 11588077BACKGROUND

  • 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.

    PMID: 39100012BACKGROUND

  • 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.

    PMID: 38546251BACKGROUND

  • 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.

    PMID: 31379230BACKGROUND

  • 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.

    PMID: 36852822BACKGROUND

Study Officials

  • Dr Muhammad Ali sheikh

    Shaikh Zayed Hospital, Lahore

    STUDY DIRECTOR

Central Study Contacts

Dr Noor Ulain

CONTACT

+92 3064687704noorulainch2@gmail.com

Dr Muhammad Sooban Qamar

CONTACT

+92 3069783238soobanqamar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (Resident)

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 12, 2025

Study Start

March 20, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)