Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

Dong-Xin Wang

Status: Completed

Conditions: Gastrointestinal Surgery

Treatments: Other: Routine fasting; Dietary Supplement: Oral carbohydrate (Outfast)

Study type: Interventional

Funder types: Other

Identifiers

NCT03204344

2017[1362]

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oral carbohydrate (Outfast)

Control group

Sham Comparator group

Description:

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.

Treatment:

Other: Routine fasting