Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

Sun Yat-sen University

Status

Completed

Conditions

Gastric Cancer

Treatments

Dietary Supplement: preoperative oral carbohydrate drink

Study type

Interventional

Funder types

Other

Identifiers

NCT02815150

2016018

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.