Uncomplicated Acute Appendicitis in ChildrenNCT07016919
Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open Appendectomy
A study testing early enteral nutrition and Conventional enteral nutrition in people with Uncomplicated Acute Appendicitis in Children, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Uncomplicated Acute Appendicitis in Children
- What is being tested?
- early enteral nutrition and Conventional enteral nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- post-op shock
- ongoing infection
- GI dysfunction such as gastroesophageal reflux disease/obstruction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shaikh Zayed federal postgraduate medical institute Lahore
Lahore, Punjab Province
Shaikh Zayed federal postgraduate medical institute Lahore, 04299230293 ext. 2205/2330, SZMCIRB1@gmail.com
Dr Muhammad Ali Sheikh, +92 3214790094, drali444@yahoo.com
About this study
Official title: Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open appendectomy-a Randomised Control Trial
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.
- Being tested
- early enteral nutrition, Conventional enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early enteral nutritionOther
Oral nutrition started within 6hours after paediatric open appendectomy
Conventional enteral nutritionOther
Oral nutrition started within 24hours after paediatric open appendectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A (Interventional group) early enteral nutrition | Experimental | Oral nutrition started within 6hours after surgery (paediatric open appendectomy) to this group Receives: 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) Receives: Other: Conventional enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of days from the day of surgery until the date of discharge (1-7days)
Measured: From enrollment until discharge from hospital (1-7days)
Secondary outcomes (2)
Complications associated with early enteral nutrition
Complications such as nausea, vomiting, abdominal distension and diarrhea associated with early enteral nutrition are observed
Measured: From enrollment until 1week after discharge on follow up
Time to return of bowel activity
Time to return of bowel activity after surgery assessed by passage of flatus and stool
Measured: From enrollment until discharge from hospital (1-7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Acute Appendicitis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaikh Zayed Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Noor Ulain, Shaikh Zayed Hospital, Lahore
- Investigators
- Dr Muhammad Ali sheikh, Study director, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016919
- Sponsor's protocol ID
- TERC/SC/INT/2025/360
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37041392Mvoula 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 37667705Ying 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 35812657Shang 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 29489656Lewis 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 11588077Mahmud 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 39100012Farhad 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 38546251Gao 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 31379230Al-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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open appendectomy-a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07016919
- Acronym / sponsor ID
- TERC/SC/INT/2025/360
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Shaikh Zayed Hospital, LahoreUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Interventional group) early enteral nutrition | Experimental | Other: early enteral nutritionOral nutrition started within 6hours after surgery (paediatric open appendectomy) to this group |
| Group B Conventional enteral nutrition | Active comparator | Other: Conventional enteral nutritionOral nutrition is started to this group after 24hours of the surgery (open appendectomy) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6-14years
- Both male\& female
- Uncomplicated appendicitis(no perforation/gangrene)
- patients who underwent open appendectomy
- ASA grade 1 only
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early enteral nutritionOral nutrition started within 6hours after paediatric open appendectomy | Other | Group A (Interventional group) early enteral nutrition |
| Conventional enteral nutritionOral nutrition started within 24hours after paediatric open appendectomy | Other | Group B Conventional enteral nutrition |
Primary outcome
Length of hospital stay
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)
2 secondary outcomes
Complications associated with early enteral nutrition
Time frame: From enrollment until 1week after discharge on follow up
Time to return of bowel activity
Time frame: From enrollment until discharge from hospital (1-7days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 37041392Zhang 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.
- Results publication: PubMed 37667705Mvoula 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.
- Results publication: PubMed 35812657Ying 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.
- Results publication: PubMed 29489656Shang 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.
- Results publication: PubMed 11588077Lewis 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.
- Results publication: PubMed 39100012Mahmud 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.
- Results publication: PubMed 38546251Farhad 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.
- Results publication: PubMed 31379230Gao 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.
- Results publication: PubMed 36852822Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Muhammad Ali sheikh study director
Shaikh Zayed Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early enteral nutrition and Conventional enteral nutrition in people with Uncomplicated Acute Appendicitis in Children, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Noor Ulain (+92 3064687704, noorulainch2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From enrollment until discharge from hospital (1-7days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016919, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.