Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

Safety and Effectiveness of Oral Administration of 5% Glucose Solution 250ml 2-3 Hours Before Surgery in Gastric Cancer Patients for Elective Radical Resection

This study aims to assess the impact of preoperative oral carbohydrate drink on gastric emptying and PH of gastric fluid in gastric cancer patients directly. Furthermore, investigators aim to evaluate the safety and effectiveness of preoperative oral carbohydrate in elective gastric cancer surgery, providing direct evidence for clinical practice.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Dietary supplement: preoperative oral carbohydrate drink

Detailed Description

In clinic, administration of oral carbohydrate 2-3 hours before surgery has been widely applied in elective colorectal surgery. However, no direct evidence has been showed that whether it is safe to do so in gastric cancer patients who are fit for elective radical gastric resection.

This study aims to discuss the impact and safety of oral administration of 5% glucose solution 250ml 2-3 hours before elective gastric cancer surgery. It is an equivalence study, which refers to a single-center, prospective, single blind, and randomized controlled study design. Eighty-eight patients with gastric adenocarcinoma are going to be enrolled in the study, who will be allocated into control or treatment group. Patients in control group follow the traditional routine of 6-8 hours preoperative fasting, while those in the treatment group will orally intake 250ml 5% glucose solution 2-3 hours before surgery. The primary end-point is the preoperative gastric residual volume. The secondary end-points include preoperative PH of gastric fluid, assessment of perioperative psychosomatic conditions, rate of perioperative complications, level of insulin sensitivity, recovery of bowel function, and the length of hospital stay, etc.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 80 years
• Histologically confirmed gastric adenocarcinoma
• Tumor of cT2-4aN0-2 in preoperative gastroscopy, endoscopic ultrasound, and/or abdominal computed tomography
• Fit for elective radical resection
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• American Society of Anesthesiology (ASA) status I to III
• Body mass index (BMI) of 17.5-27.5 kg/m2 .Patient agreed to participate this trial through informed consent.

Exclusion Criteria:

• Symptoms of pyloric obstruction
• Impaired bowel function, using drugs disturbing gastric secretion and gastric emptying
• History of gastric resection
• History of gastric cancer treatment
• History of major abdominal operation, or diffuse peritonitis
• Diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones
• Potential difficult airway as evaluated by anesthesiologist
• Pregnancy or breastfeeding were excluded in this trial .Patients would also be excluded if the following circumstances occurred: (1) failure of endotracheal intubation; (2) failure of intra-operative gastroscopy; or (3) irresectable tumor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery.	Dietary supplement: preoperative oral carbohydrate drink; 5% glucose solution 250ml 2-3 hours before surgery
No Intervention: Control group; Patients undergo 6-8 hours of preoperative fasting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative gastric residual volume of gastric fluid	After anesthesia induction with 100-120mg propofol and 0.5 mg/kg rocuronium bromide and tracheal intubation, keep the patient in left lateral decubitus position. Insert the gastroscope ( Olympus 260) and perform complete suction of gastric fluid under direct vision with the suction apparatus connecting to the sterile airtight collector. Measure the volume of the gastric fluid in collector with a cylindrical measuring cup, accurate to 0.1ml. Repeat it and then take an average.	20-30 minutes before the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative PH of gastric fluid	bromide and tracheal intubation, keep the patient in left lateral decubitus position. Insert the gastroscope ( Olympus 260) and perform complete suction of gastric fluid under direct vision with the suction apparatus connecting to the sterile airtight collector. Inject 1ml clear gastric fluid into a vacuum drying tube by syringe and detect the PH value with the Delta 320 PH Detector twice and calculate the average value.	20-30 minutes before the surgery
Preoperative thirsty/hungry scoring	Visual analogue scale with the score 0-10, 0 the least, 10 the most	1 hour before the surgery
Rate of perioperative complications	Including surgery-specific complications, such as bleeding, anastomosis leakage, and non-surgery-specific ones, such as lung infection, urinary tract infection, etc.	7-8 days
Recovery of bowel function	Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet	3-7 days
Perioperative insulin sensitivity	Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ [ log ( I0) + log (G0) ]，I0 is the fasting insulin value, G0 is the fasting blood glucose value。	8 days
Length of hospital stay	Post operative hospital stay	2-3 weeks
Readmission rate within 30 days post operation	Readmission for any reason within 30 days after the surgery.	1 month after surgery
Reoperation rate within 30 days post operation	Reoperation that happens within 30 days after the primary surgery.	1 month after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: The First Affiliated Hospital of the Fourth Military Medical University; First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Dongjie Yang, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): January 6, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: June 5, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2016018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No