Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

NCT ID: NCT02815150

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2019-01-30

Brief Summary

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.

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Treatment group

Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery.

Group Type: EXPERIMENTAL

preoperative oral carbohydrate drink

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

Patients undergo 6-8 hours of preoperative fasting.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

preoperative oral carbohydrate drink

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of the Fourth Military Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Dongjie Yang

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dongjie Yang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2016018

Identifier Type: -

Identifier Source: org_study_id