Clinical trial NCT03204344: Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients
Official title: Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Surgery
Keywords: Gastrointestinal surgery
Preoperative oral carbohydrate
Diabetic patients
Postoperative recovery
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recovery of gastrointestinal function
timeFrame: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.
Secondary outcomes:
measure: Subjective feelings
timeFrame: Before anesthesia induction and at 4-6 hours after surgery.
measure: Blood glucose variation
timeFrame: From 22:00 on the day before surgery until 24 hours after surgery.
measure: Insulin resistance (in part of patients)
timeFrame: Assessed at 24 hours after surgery.
measure: Length of stay in hospital after surgery.
timeFrame: From end of surgery until hospital discharge, up to 30 days after surgery.
measure: Incidence of postoperative complications
timeFrame: From end of surgery until 30 days after surgery
measure: Time to first walking in the ground and distance of walking after surgery.
timeFrame: During the first 5 days after surgery
measure: All cause 30-day mortality
timeFrame: At 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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