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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Interventional group) early enteral nutrition | Experimental | Oral nutrition started within 6hours after surgery (paediatric open appendectomy) to this group |
|
| Group B Conventional enteral nutrition | Active Comparator | Oral nutrition is started to this group after 24hours of the surgery (open appendectomy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early enteral nutrition | Other | Oral nutrition started within 6hours after paediatric open appendectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications associated with early enteral nutrition | Complications such as nausea, vomiting, abdominal distension and diarrhea associated with early enteral nutrition are observed | From enrollment until 1week after discharge on follow up |
| Time to return of bowel activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Noor Ulain | Contact | +92 3064687704 | noorulainch2@gmail.com | |
| Dr Muhammad Sooban Qamar | Contact | +92 3069783238 | soobanqamar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Muhammad Ali sheikh | Shaikh Zayed Hospital, Lahore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaikh Zayed federal postgraduate medical institute Lahore | Recruiting | Lahore | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37041392 | Result | 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. | |
| 37667705 | Result | 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. |
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| Conventional enteral nutrition | Other | Oral nutrition started within 24hours after paediatric open appendectomy |
|
Time to return of bowel activity after surgery assessed by passage of flatus and stool |
| From enrollment until discharge from hospital (1-7days) |
| 35812657 | Result | 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. |
| 29489656 | Result | 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. |
| 11588077 | Result | 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. |
| 39100012 | Result | 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. |
| 38546251 | Result | 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. |
| 31379230 | Result | 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. |
| 36852822 | Result | 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. |