The First Affiliated Hospital of Chongqing Medical University(No. 1 Youyi Road, Yuzhong District, Chongqing 400016, China)
Chongqing, Chongqing Municipality, 400016, China
NCT Number: NCT07822763
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Chongqing, Chongqing Municipality, 400016, China
This prospective, randomized trial aims to evaluate the efficacy and safety of preoperative oral carbohydrate loading for postoperative gastrointestinal recovery in patients with metabolic syndrome undergoing bariatric surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the preoperative oral carbohydrate loading group or the placebo group.
Participants in both groups will follow a standardized preoperative fasting protocol, with solid food prohibited for at least 6 hours before induction of anesthesia and clear liquids discontinued 2 hours before surgery. Participants in the POC group will consume 400 mL of an oral carbohydrate-containing beverage 2 hours before surgery, whereas participants in the control group will consume an equal volume of a placebo beverage with a similar appearance and taste but containing no carbohydrates at the same time point.
The primary outcome is postoperative gastrointestinal functional recovery, assessed using the GI-3 criteria. GI-3 recovery is defined as tolerance of oral intake accompanied by recovery of lower gastrointestinal function. The study will evaluate both the proportion of participants achieving GI-3 recovery within the predefined postoperative period and the time to GI-3 recovery.
Secondary outcomes include other measures related to postoperative gastrointestinal recovery, postoperative nausea and vomiting, quality of recovery, length of hospital stay, and other postoperative recovery-related outcomes. Perioperative blood glucose levels and glycemic variability will be assessed to evaluate the metabolic safety of preoperative oral carbohydrate loading.
Safety outcomes related to preoperative oral carbohydrate intake will also be assessed. Gastric ultrasonography will be performed before induction of anesthesia to evaluate gastric volume, corrected gastric volume, gastric antral cross-sectional area, and Perlas grade. The occurrence of perioperative regurgitation or pulmonary aspiration will also be recorded.
This study aims to determine whether, compared with placebo, preoperative oral carbohydrate loading can enhance postoperative gastrointestinal recovery in patients with metabolic syndrome undergoing bariatric surgery without increasing clinically significant perioperative glycemic fluctuations or aspiration-related risks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants 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.
Participants 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.
Time frame: 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 frame: From the end of surgery up to 7 days after surgery.
Time frame: From the end of surgery up to 7 days after surgery.
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
Time frame: Days 1 - 4 postoperatively
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.
Time frame: Days 1 - 7 and 30 postoperatively
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.
Time frame: Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
Time frame: Calculated based on blood glucose levels measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
Time frame: From the end of surgery up to 7 days after surgery.
Time frame: From the end of surgery up to 7 days after surgery.
Time frame: Within 30 days after surgery
Time frame: Within 30 days after surgery
Time frame: Within 30 days after surgery
Classified according to the Clavien-Dindo classification criteria for complications
Time frame: Before anaesthetic induction
Calculated using the formula (AP × CC × π)/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter.
Time frame: Before anaesthetic induction
= 27.0 + 14.6 × CSA - 1.28 × age
Time frame: Before anaesthetic induction
Graded according to the Perlas system: grade 0 (no content in either position), grade 1 (only a small amount of fluid visible in the right lateral decubitus position), and grade 2 (distended antrum with fluid visible in both positions).
Time frame: Before anaesthetic induction
Recalculated in mL kg-¹
Time frame: From anesthesia induction to discharge from the post-anesthesia care unit.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Chongqing Medical University
Other
Preoperative Oral Carbohydrate Loading for Enhanced Gastrointestinal Recovery After Bariatric Surgery in Patients With Metabolic Syndrome
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