Effects of preoperative oral carbohydrate loading on postoperative outcomes and change in neutrophil/lymphocyte ratio and following elective colorectal cancer surgery : A randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To compare the effect of oral carbohydrate loading and preoperative prolonged fasting on
研究概览
简要总结
Title:
Effects of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes and Change in Neutrophil/Lymphocyte Ratio Following Elective Colorectal Cancer Surgery: A Randomized Controlled Study.
Study Overview:
This randomized controlled trial (RCT) investigates the effects of preoperative oral carbohydrate loading (CHO) on postoperative outcomes and changes in the neutrophil/lymphocyte ratio (NLR) in colorectal cancer (CRC) patients undergoing elective surgery.
Background & Rationale:
CRC is a leading cause of cancer-related deaths.
Prolonged fasting before surgery triggers inflammatory responses, affecting patient recovery.
CHO loading, part of Enhanced Recovery After Surgery (ERAS) protocol, may reduce post-surgical complications and improve immune response.
• Change in NLR can serve as an inexpensive hematological marker to predict postoperative recovery and complications.
Objectives:
- Primary:
Compare postoperative complications (classified by Clavien-Dindo scale) between CHO-loaded and fasting groups.
Investigate the impact on complications such as wound infections, pneumonia, ileus, renal failure, septic shock, and MODS.
- Secondary:
Compare change in NRL between groups.
Assess the time to discharge based on criteria such as return of bowel function, tolerance to diet, pain management, and absence of infections.
Study Design:
Type: Randomized Controlled Trial (RCT).
Sample Size: 68 patients (34 in each group).
Study Groups:
Control: Conventional preoperative fasting.
Intervention: CHO group receives maltodextrin drink (400ml night before and 200ml 2 hours before surgery).
Randomization: Block randomization with concealed allocation.
Blinding: Not involved.
Methodology:
-
Preoperative assessment includes demographic data and baseline NLR.
-
Both groups undergo standard preoperative treatments.
-
Postoperative complications monitored for 30 days.
-
NLR measured on postoperative days 1, 3, and 5.
-
Time to discharge evaluated using standardized criteria.
Statistical Analysis:
Continuous variables: Mean/Median (Student’s t-test/Mann-Whitney test).
Categorical variables: Chi-square/Fisher’s exact test.
Multivariable analysis for risk assessment.
Expected Outcomes:
CHO loading is hypothesized to reduce complications and improve postoperative recovery.
Lower change in NRL in the CHO group suggests reduced systemic inflammation.
Shorter hospital stay and fewer severe complications expected in the intervention group.
Ethical Considerations:
Risks include multiple venous samplings.
Precautions taken for potential adverse effects.
Conclusion:
This study aims to establish CHO loading as a cost-effective and beneficial intervention in colorectal cancer surgery by assessing its impact on complications, inflammation, and hospital stay duration.
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 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients admitted for elective colorectal surgery in JIPMER more than 18 years of age.
排除标准
- •Recurrent CRC
- •Emergency surgeries
- •Metastatic disease
- •Known cases of chronic diseases such as uncontrolled diabetes mellitus, uncontrolled hypertension, hematological illnesses.
- •Cases of psychiatric illnesses, in which cases consent will not be there.
结局指标
主要结局
To compare the effect of oral carbohydrate loading and preoperative prolonged fasting on
时间窗: upto 30 days post operatively
The post operative complications on the basis of Clavein-Dindo classification, and
时间窗: upto 30 days post operatively
GRADE 1 Elevated serum creatine
时间窗: upto 30 days post operatively
Confusion
时间窗: upto 30 days post operatively
GRADE 2 Pneumonia
时间窗: upto 30 days post operatively
Delirium
时间窗: upto 30 days post operatively
Uro-infection
时间窗: upto 30 days post operatively
Wound infection
时间窗: upto 30 days post operatively
GRADE 3 Anastomotic leakage
时间窗: upto 30 days post operatively
Ileus
时间窗: upto 30 days post operatively
Abdominal wall dehiscence
时间窗: upto 30 days post operatively
Reoperation
时间窗: upto 30 days post operatively
GRADE 4 Respiratory failure
时间窗: upto 30 days post operatively
Renal failure
时间窗: upto 30 days post operatively
Septic Shock
时间窗: upto 30 days post operatively
MODS
时间窗: upto 30 days post operatively
GRADE 5 Death of patient
时间窗: upto 30 days post operatively
次要结局
- 2. The post operative time to discharge based on fulfillment of the following criteria:(A. Passage of stools/ Functional moving stoma)
- to compare the effect of oral carbohydrate loading group and prolonged fasting group over post operative neutrophil to lymphocyte ratio and the significance of change(preoperative day before surgery)
研究者
Jinendra Jain
Jawaharlal Institute of Postgraduate Medical Education and Research
