This prospective randomized controlled trial aims to evaluate the effect of preoperative oral carbohydrate loading on postoperative gastrointestinal recovery in patients with metabolic syndrome undergoing bariatric surgery. Eligible participants will be randomly assigned to either a preoperative oral carbohydrate drink group or a standard preoperative fasting group.
The primary objective of this study is to determine whether preoperative oral carbohydrate loading can facilitate early postoperative gastrointestinal recovery. Outcome measures will include the proportion of patients achieving postoperative gastrointestinal recovery, time to postoperative gastrointestinal recovery, perioperative blood glucose levels, and other postoperative recovery-related outcomes. This study aims to provide clinical evidence regarding the efficacy and safety of preoperative oral carbohydrate loading in patients with metabolic syndrome undergoing bariatric surgery.
adults aged 18-65 years;
diagnosis of metabolic syndrome (≥3 of the following: elevated waist circumference, elevated triglycerides, elevated blood pressure, elevated fasting glucose, and reduced HDL-C);
eligibility for bariatric surgery(body mass index ≥35 kg/m² or metabolic disease with body mass index 27.5-34.9 kg/m²), with planned Roux-en-Y gastric bypass or sleeve gastrectomy;
provision of written informed consent and willingness to complete follow-up.
gastrointestinal motility disorders;
severe cardiovascular, pulmonary, hepatic, or renal dysfunction;
HbA1c ≥8.0%;
fasting plasma glucose >10.0 mmol/L at the preoperative assessment;
Parallel
Preoperative oral carbohydrate loading
Other interventionParticipants in the POC group were fasted from solid foods for ≥6 hours (≥8 hours after fatty or meat-containing meals), with clear liquids permitted until 2 hours before surgery, and consumed 400 mL of a carbohydrate-containing clear liquid 2 hours before surgery. The beverage provided 12.5 g of carbohydrates per 100 mL and contained no fiber, protein, or fat.
The placebo
Other interventionParticipants in the placebo group were instructed to follow the same preoperative fasting regimen and to consume 400 mL of a matching non-caloric, carbohydrate-free clear liquid 2 hours before surgery. The placebo was similar to the carbohydrate-containing beverage in appearance and taste，but contained no carbohydrates, fiber, protein, or fat.
GI-3 recovery rate within 72 hours after surgery
GI-3 is a composite endpoint defined as the ability to tolerate oral intake (consumption of food and drink at three consecutive meals without significant nausea or vomiting), accompanied by flatus or defecation.
Time to GI-3 recovery
Time to GI-2 recovery
GI-2 is a composite endpoint defined as the ability to tolerate oral intake (consumption of food and drink at three consecutive meals without significant nausea or vomiting), accompanied by defecation
Postoperative Nausea and Vomiting Score
Postoperative nausea and vomiting were assessed using the Postoperative Nausea and Vomiting Score, ranging from 0 to 6, with higher scores indicating more severe postoperative nausea and vomiting.
15-item Quality of Recovery Score
Quality of recovery was assessed using the 15-item Quality of Recovery Score, ranging from 0 to 150, with higher scores indicating better postoperative recovery.
Unplanned readmission rate within 30 days after surgery
Postoperative complications
Classified according to the Clavien-Dindo classification criteria for complications
Gastric cross-sectional area (CSA)
Calculated using the formula (AP × CC × π)/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter.
Gastric volume
= 27.0 + 14.6 × CSA - 1.28 × age
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