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临床试验/NCT07016919
NCT07016919招募中不适用

Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open appendectomy-a Randomised Control Trial

Shaikh Zayed Hospital, Lahore1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
88
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Group A (Interventional group) early enteral nutrition

Experimental

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

干预措施: early enteral nutrition (Other)

Group B Conventional enteral nutrition

Active Comparator

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

干预措施: Conventional enteral nutrition (Other)

结局指标

主要结局

Length of hospital stay

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

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

次要结局

  • 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))

研究者

发起方
Shaikh Zayed Hospital, Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Noor Ulain

Doctor (Resident)

Shaikh Zayed Hospital, Lahore

研究点 (1)

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