Comparison of conventional overnight fasting with abbreviated fasting protocol regarding the mucosal visibility in patients undergoing esophagogastroduodenoscopy: a non-inferiority, randomised controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- In patients undergoing elective esophagogastroudonoscopy, following conventional overnight fasting protocol and abbreviated fasting protocol, to evaluate and compare mucosal visibility during elective EGD, using the Total Visibility Score.
研究概览
简要总结
This randomised controlled trial investigates whether an abbreviated fasting protocol, including a light breakfast and water allowed closer to procedure time, is noninferior to the conventional overnight fasting protocol in terms of gastric mucosal visibility during unsedated esophagogastroduodenoscopy (EGD).
Study Design
Participants: Outpatients scheduled for elective EGD
Randomisation Using the SNOSE technique into two groups: control and intervention
Control Group Nil per oral after midnight, only water up to 300 mL allowed until 8 AM, EGD between 10 and 12 PM
Intervention Group: Light breakfast, two idlis plus an optional side dish at 8 AM, metoclopramide at 6 AM water up to 300 mL until 10 AM, EGD at 12 PM
EGD Procedure
Performed without sedation by experienced endoscopists
Mucosal visibility assessed in four gastric segments using a standardised 4-point scoring system
The total visibility score TVS ranges from 4 to 16. Less than 7 is acceptable visibility; seven or more is insufficient visibility.
Other Assessments
Patient comfort will be measured using the Visual Analogue Scale VAS before and after EGD.
Procedure duration and adverse events are monitored post-EGD and up to one week after
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged between 18 to 70 years.
- •Participants planned for elective, unsedated EGD.
- •Participants scheduled for EGD between 10 AM to 12 PM.
排除标准
- •Patients with suspected or known case of GI obstruction.
- •Already receiving prokinetic medications.
- •Known diabetic patients.
- •Patients scheduled for emergency or therapeutic EGD.
- •Pregnant or lactating females.
- •History of upper GI surgery.
- •Participants with known sensitivity or intolerance to metoclopramide.
- •Participants on antiepileptic drugs or medication for extrapyramidal disorders.
结局指标
主要结局
In patients undergoing elective esophagogastroudonoscopy, following conventional overnight fasting protocol and abbreviated fasting protocol, to evaluate and compare mucosal visibility during elective EGD, using the Total Visibility Score.
时间窗: In patients undergoing elective esophagogastroudonoscopy, following conventional overnight fasting protocol and abbreviated fasting protocol, to evaluate and compare mucosal visibility during elective EGD, using the Total Visibility Score. Which will be assessed during the procedure.
次要结局
- a. The comfort of the patient, before and during EGD, will be assessed using the Visual Analogue Scale (VAS).(before and after the procedure)
- b. The incidence of adverse events such as nausea, vomiting, aspiration, or hypoglycemia.(Before and after the procedure)
- c. The percentage of patients requiring repeat EGD.(after the procedure)
研究者
KAUSIKI MISHRA
JIPMER