Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815150
• Other study ID #: 2016018
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2019
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 30, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18< Age <80

• Gastric adenocarcinoma, proved by endoscopic biopsy

• Fit for elective radical resection

• ASA <? and NYHA <?

• 17.5< BMI <27.5 kg/m2

• Informed consent

Exclusion Criteria:

• Patients with symptoms of pyloric obstruction or gastric residual volume =100ml confirmed by preoperative endoscopy

• Patients with impaired bowel function, using drugs disturbing gastric secretion and gastric emptying within 24 hours, or with high risk of aspiration

• Patients with a previous history of medium/large abdominal operation, or with a previous history of diffuse peritonitis

• Patients with diabetes or impaired glucose tolerance, or with abnormality in other endocrine hormones

• Patients with potential difficult airway

• Noncurative resection

• Intraoperative blood loss =500ml

• Patients with preoperative chemoradiotherapy

• Pregnant or lactating women

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Dietary Supplement:
• preoperative oral carbohydrate drink
5% glucose solution 250ml 2-3 hours before surgery

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Preoperative thirsty/hungry scoring	Visual analogue scale with the score 0-10, 0 the least, 10 the most	1 hour before the surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay	Post operative hospital stay	2-3 weeks
Secondary	Readmission rate within 30 days post operation	Readmission for any reason within 30 days after the surgery.	1 month after surgery
Secondary	Reoperation rate within 30 days post operation	Reoperation that happens within 30 days after the primary surgery.	1 month after surgery