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Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
preoperative oral carbohydrate drink
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18< Age <80
  • Gastric adenocarcinoma, proved by endoscopic biopsy
  • Fit for elective radical resection
  • ASA <Ⅲ and NYHA <Ⅲ
  • 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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

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

Patients undergo 6-8 hours of preoperative fasting.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Preoperative thirsty/hungry scoring
Visual analogue scale with the score 0-10, 0 the least, 10 the most
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.
Recovery of bowel function
Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet
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。
Length of hospital stay
Post operative hospital stay
Readmission rate within 30 days post operation
Readmission for any reason within 30 days after the surgery.
Reoperation rate within 30 days post operation
Reoperation that happens within 30 days after the primary surgery.

Full Information

First Posted
June 5, 2016
Last Updated
January 29, 2019
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02815150
Brief Title
Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (undefined)
Primary Completion Date
January 6, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Preoperative oral carbohydrate drink: patients drink 5% glucose solution 250ml 2-3 hours before surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients undergo 6-8 hours of preoperative fasting.
Intervention Type
Dietary Supplement
Intervention Name(s)
preoperative oral carbohydrate drink
Intervention Description
5% glucose solution 250ml 2-3 hours before surgery
Primary Outcome Measure Information:
Title
preoperative gastric residual volume of gastric fluid
Description
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 Outcome Measure Information:
Title
Preoperative PH of gastric fluid
Description
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
Title
Preoperative thirsty/hungry scoring
Description
Visual analogue scale with the score 0-10, 0 the least, 10 the most
Time Frame
1 hour before the surgery
Title
Rate of perioperative complications
Description
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
Title
Recovery of bowel function
Description
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
Title
Perioperative insulin sensitivity
Description
Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ [ log ( I0) + log (G0) ],I0 is the fasting insulin value, G0 is the fasting blood glucose value。
Time Frame
8 days
Title
Length of hospital stay
Description
Post operative hospital stay
Time Frame
2-3 weeks
Title
Readmission rate within 30 days post operation
Description
Readmission for any reason within 30 days after the surgery.
Time Frame
1 month after surgery
Title
Reoperation rate within 30 days post operation
Description
Reoperation that happens within 30 days after the primary surgery.
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18< Age <80 Gastric adenocarcinoma, proved by endoscopic biopsy Fit for elective radical resection ASA <Ⅲ and NYHA <Ⅲ 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongjie Yang
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

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