Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

First Affiliated Hospital, Sun Yat-Sen University88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Gastric Cancer

Interventions

preoperative oral carbohydrate drinkDIETARY_SUPPLEMENT

5% glucose solution 250ml 2-3 hours before surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: 20-30 minutes before the surgery

Secondary Outcomes

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.

Time frame: 20-30 minutes before the surgery

Preoperative thirsty/hungry scoring

Visual analogue scale with the score 0-10, 0 the least, 10 the most

Time frame: 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.

Time frame: 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

Time frame: 3-7 days

Perioperative insulin sensitivity

Data from ClinicalTrials.gov

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