Comparison of Oral Carbohydrate Solution Versus Clear Liquid Diet in Acute Pancreatitis:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- rate of feeding intolerance
研究概览
简要总结
Background:
Acute pancreatitis (AP) is an inflammatory condition associated with increased metabolic demands and negative nitrogen balance, making early nutritional support a critical component of management. Concentional practice favored prolonged fasting and delayed oral intake; however, recent evidence supports early oral feeding. Oral carbohydrate solutions (OCS) may provide early caloric support with minimal pancreatic stimulation, but data comparing OCS with clear liquid (CL) diets which is current practice remain limited, particularly in South Asian populations.The Convential diet (CD )group started at liquid diet then progressed towards soft and then solid diet experienced recurring pain at a considerably higher rate than the oral high carbohydrate solution (OCS )group providing essential calories,(13.2% vs. 3.8%, p < 0.001).OCS showed decrease rate of post prandial recurrent abdominal pain.
Objective:
To compare oral carbohydrate solution versus clear liquid diet as the initial oral feeding strategy in patients with acute pancreatitis, focusing on feeding intolerance and length of hospital stay.
Methods:
This prospective randomized controlled trial will be conducted at a tertiary-care hospital in Lahore, Pakistan. Adult patients (18-70 years) with mild to moderately severe acute pancreatitis will be randomized to receive either an oral carbohydrate solution (10% dextrose in water) or a clear liquid diet as the initial oral feed. The primary outcomes will be feeding intolerance within 24 hours and length of hospital stay. Secondary outcomes include time to successful oral feeding, time to soft diet, changes in pain scores, inflammatory markers (CRP, WBC), glycemic response, need for nutritional escalation, complications, and patient satisfaction. Data will be analyzed using SPSS version 26, with a p-value ≤ 0.05 considered statistically significant.
Conclusion:
If proven safe and effective, oral carbohydrate solution may serve as a simple, cost-effective and well-tolerated alternative to clear liquid diets for early oral feeding in acute pancreatitis, particularly in resource limited settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range between 18 years and 70 years
- •Diagnosis of mild or moderately severe acute pancreatitis
- •Hemodynamically stable
- •Able to tolerate oral intake
- •Provided written informed consent
排除标准
- •Severe acute pancreatitis
- •Chronic pancreatitis
- •Pregnancy
- •Uncontrolled diabetes mellitus
- •Known malabsorption syndrome,
- •Patients requiring immediate enteral tube feeding or parenteral nutrition,
- •Known allergy or intolerance to carbohydrate solutions,
- •Persistent retching or vomiting
研究组 & 干预措施
ORAL CARBOHYDRATE SOLUTION GROUOP
Participant will be randomized in this group. Participant will receive an oral carbohydrate solution initiated after clinical stabilization.It will be be administrated orally with volume and frequency standardized for all participants and advancement according to study protocol.
干预措施: Oral Carbohydrate Solution (Dietary Supplement)
CLEAR LIQUID DIET GROUP
Participant will receive a standard clear liquid diet initiated after clinical stabilization as per routine institutional practice in measured frequncy and volume and advancement according to study protocol.
干预措施: Clear Liquid diet (Dietary Supplement)
结局指标
主要结局
rate of feeding intolerance
时间窗: Upto 24 hours after initiating first oral feed
Patient will be observed for 24 hours after initial feed for symptoms of feeding intolerance like pain,nausea,vomiting or abdominal distension.
Length of hospital Stay
时间窗: From hospital admission to discharge in days
Length of hospital stay will be recorded from day of admission till discharge in days.
次要结局
未报告次要终点
研究者
Aiqa Gulshan
Resident Surgeon
Jinnah Hospital
