Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

Not Applicable

Completed

• Conditions: Gastrointestinal Surgery
• Interventions: Dietary Supplement: Oral carbohydrate (Outfast); Other: Routine fasting

• Registration Number: NCT03204344
• Lead Sponsor: Dong-Xin Wang

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Study Start: 2017-08-01
• Primary Completion: 2018-05-07
• Study Completion: 2018-06-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

1. Refuse to participate in the study;
2. Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
3. Previous history of total or partial gastrectomy;
4. 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;
5. Preoperative pyloric and/or intestinal obstruction;
6. Combined surgery on other intra-abdominal organs or other parts of the body.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral carbohydrate (Outfast)	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. 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.
Control group	Routine fasting	For all patients, routine fasting (drinking water allowed) begins from 22:00 on the day before surgery， water fasting begins from 6:00 on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided from 6:00. 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 (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, magnesium sulfate) are added when becessary.

Primary Outcome Measures

Name	Time	Method
Recovery of gastrointestinal function	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 Outcome Measures

Name	Time	Method
Blood glucose variation	From 22:00 on the day before surgery until 24 hours after surgery.	Difference between the highest and the lowest blood glucose levels.
Subjective feelings	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).
Insulin resistance (in part of patients)	Assessed at 24 hours after surgery.	Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation.
Incidence of postoperative complications	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.
Time to first walking in the ground and distance of walking after surgery.	During the first 5 days after surgery	Time to first walking in the ground and distance of walking after surgery.
Length of stay in hospital after surgery.	From end of surgery until hospital discharge, up to 30 days after surgery.	Length of stay in hospital after surgery.
All cause 30-day mortality	At 30 days after surgery	All cause 30-day mortality

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China