The Effect of Carbohydrate Loading 2 Hours Before Upper Endoscopy on Gastric Residual Volume and Patient's Well-being Score : A Single-Blind, Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To compare the gastric residual volume 2 hours after carbohydrate loading (intervention group) and plain water group (control group)
研究概览
简要总结
This is a single-blind randomized controlled trial with a stratified (diabetes mellitus, non-diabetes mellitus), balanced randomization (1:1), placebo-controlled study regarding the effect of carbohydrate loading 2 hours prior to the outpatient upper endoscopic procedure. All patients who were assigned for outpatient oesophagogastroduodenoscopy (OGDS) were invited to join in this study voluntarily from January 2021 until August 2021. This study was conducted in the Endoscopy Unit, Hospital Universiti Sains Malaysia, Kubang Kerian, Malaysia. The endoscopists that performed this procedure were blinded and there was trained staff who was not involved in the study to assess the well-being score. The study protocol had been approved by the Human Research Ethics Committee of Universiti Sains Malaysia (JEPeM) with the assigned protocol code USM/JEPeM/20080414.
详细描述
Patient planned for OGDS in HUSM will be randomized into 2 groups. Plain water is given to group A of subject and carbohydrate loading is given to group B subject 2 hours before OGDS. Gastric residual volume is visualized directly and measured through aspiration via OGDS and subject's well-being is assessed for both group of the subject prior and after clear fluid have been given.
Methodology :
Research design :- This is a single-blind randomized controlled trial. This is a stratified (diabetes mellitus, non-diabetes mellitus) with balanced randomization (1:1), placebo-controlled study Study area :- This study will be conducted in the endoscopy room, Hospital Universiti Sains Malaysia (HUSM) in Kubang Kerian, Kelantan, Malaysia
All subjected planned for OGDS with the complaint of one or more of the following symptoms : Bothersome postprandial fullness, early satiety, epigastric pain or epigastric burning and fulfill the inclusion criteria are selected. Patients will be approached and be explained regarding the study in surgical outpatient clinic before OGDS. The patient will be approached again on the day of OGDS, if agree to participate, informed consent will be obtained. Informed consent will be obtained after explanation regarding the study and procedure again by researcher nurse.
The allocation sequence is according to computer-generated random number list, it was prepared by an investigator with no clinical involvement in the trial. The allocation sequence was concealed from researcher enrolling and assessing participants. The allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and identification number of the participants will be written on a book together with the series number on the envelope. The details in the book will be kept confidentially.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient 18 years old and above
- •Agree to participate
排除标准
- •History of upper gastrointestinal surgery
- •Patient with active gastrointestinal bleeding
- •Unstable clinical condition
- •Mentally disable or who cannot give an informed consent
- •Patient on the nasogastric feeding tube
- •Pregnant patient
- •American Society of Anesthesiologists classification of physical status grade 3 or above
- •Insulin dependent Diabetes Mellitus more than 10 years
- •Patient who is carbohydrate intolerance
研究组 & 干预措施
Plain water
Group A patient will be given 400cc of plain water, 2 hours prior to gastroscopy
干预措施: Plain water (Other)
Carborie
Group B patient will be given 400cc of carborie (carbohydrate drink), 2 hours prior to gastroscopy
干预措施: Carborie (Other)
结局指标
主要结局
To compare the gastric residual volume 2 hours after carbohydrate loading (intervention group) and plain water group (control group)
时间窗: 2 hour before OGDS
Patients will be randomised into control group and intervention group. Those in intervention group will have to drink clear water containing carbohydrate (carborie) 2 hours prior to gastroscopy. Endoscopist will measure patient's gastric residual volume. Residual gastric fluid will be aspirated into the container, final volume will be measured.
次要结局
- To compare the patient's well-being after ingestion of carbohydrate loading (intervention group) and plain water (control group)(2 hours)
研究者
MOHD FIRDAUS BIN ZULKIFLI
Dr. Mohd Firdaus bin Zulkifli
Hospital Universiti Sains Malaysia