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Completed

NCT Number: NCT02815150

Safety of 250ml Preoperative Carbohydrate Drink in Gastric Cancer Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

preoperative oral carbohydrate drink

Dietary Supplement

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

Primary outcomes

  1. preoperative gastric residual volume of gastric fluid

    Time frame: 20-30 minutes before the surgery

    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 outcomes

  1. Preoperative PH of gastric fluid

    Time frame: 20-30 minutes before the surgery

    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.

  2. Preoperative thirsty/hungry scoring

    Time frame: 1 hour before the surgery

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

  3. Rate of perioperative complications

    Time frame: 7-8 days

    Including surgery-specific complications, such as bleeding, anastomosis leakage, and non-surgery-specific ones, such as lung infection, urinary tract infection, etc.

  4. Recovery of bowel function

    Time frame: 3-7 days

    Record the time, by using postoperative days(POD), to first flatus, first stool and the time to endure semifluid diet

  5. Perioperative insulin sensitivity

    Time frame: 8 days

    Quantitative Insulin Sensitivity Check Index, QUICKI = 1/ [ log ( I0) + log (G0) ],I0 is the fasting insulin value, G0 is the fasting blood glucose value。

  6. Length of hospital stay

    Time frame: 2-3 weeks

    Post operative hospital stay

  7. Readmission rate within 30 days post operation

    Time frame: 1 month after surgery

    Readmission for any reason within 30 days after the surgery.

  8. Reoperation rate within 30 days post operation

    Time frame: 1 month after surgery

    Reoperation that happens within 30 days after the primary surgery.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • The First Affiliated Hospital of the Fourth Military Medical University

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2016
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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