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NCT Number: NCT03204344

Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate improves postoperative recovery. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

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Key information

Conditions

Gastrointestinal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

Studies show that avoiding long-time fasting by oral carbohydrates 2 hours before surgery attenuates discomfort and anxiety; it also reduces stress, insulin resistance and catabolism in patients undergoing gastrointestinal surgery, resulting in earlier recovery of gastrointestinal function and short length of hospital stay after surgery. However, for diabetic patients scheduled to undergo gastrointestinal surgery, the risks and benefits of preopertive oral carbohydrate remain unclear. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of 18 years and beyond;
  • Diagnosed with type 2 diabetes before surgery;
  • Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more;
  • Provide signed writen informed consents.

Exclusion criteria

  • Refuse to participate in the study;
  • Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
  • Previous history of total or partial gastrectomy;
  • Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher;
  • Preoperative pyloric and/or intestinal obstruction;
  • Combined surgery on other intra-abdominal organs or other parts of the body.

Treatment and study plan

Oral carbohydrate (Outfast)

Dietary Supplement

For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated by an endocrinologist according to patients' daily glucose controlling plan.

For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated is the same way as described above.

Routine fasting

Other

For all patients, routine fasting (water drinking allowed) begin from 22:00 on the day before surgery until entering the operating room on the day of surgery.

For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added in the 5% glucose (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, and magnesium sulfate) are added when considered necessary.

Primary outcomes

  1. Recovery of gastrointestinal function

    Time frame: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.

    Time to first flatus and defecation after surgery.

Secondary outcomes

  1. Subjective feelings

    Time frame: Before anesthesia induction and at 4-6 hours after surgery.

    Four subjective feelings, including the degree of being thirsty, hungry, tired and anxious, are assessed with Numeric Rating Scale (NRS, an 11-point scale where 0 = no feeling at all and 10 = the worst feeling).

  2. Blood glucose variation

    Time frame: From 22:00 on the day before surgery until 24 hours after surgery.

    Difference between the highest and the lowest blood glucose levels.

  3. Insulin resistance (in part of patients)

    Time frame: Assessed at 24 hours after surgery.

    Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation.

  4. Length of stay in hospital after surgery.

    Time frame: From end of surgery until hospital discharge, up to 30 days after surgery.

    Length of stay in hospital after surgery.

  5. Incidence of postoperative complications

    Time frame: From end of surgery until 30 days after surgery

    Postoperative complications are defined as newly occurred medical conditions that have harmful effects on patients' recovery and require therapeutic intervention.

  6. Time to first walking in the ground and distance of walking after surgery.

    Time frame: During the first 5 days after surgery

    Time to first walking in the ground and distance of walking after surgery.

  7. All cause 30-day mortality

    Time frame: At 30 days after surgery

    All cause 30-day mortality

Sponsors and collaborators

Lead sponsor

Dong-Xin Wang

Other

Registry information

Official study title

Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Sep 9, 2021

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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