Preoperative Oral Carbohydrate Loading and Gastrointestinal Recovery After Bariatric Surgery in Metabolic Syndrome
Preoperative Oral Carbohydrate Loading for Enhanced Gastrointestinal Recovery After Bariatric Surgery in Patients With Metabolic Syndrome
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Wei Ke, PhD
- Telefonní číslo: +86 13883904332
- E-mail: wk202448@hospital-cqmu.com
Studijní místa
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Čína, 400016
- The First Affiliated Hospital of Chongqing Medical University（No. 1 Youyi Road, Yuzhong District, Chongqing 400016, China）
-
Kontakt:
- Ren Li, PhD
- Telefonní číslo: 8618323187421
- E-mail: renli177@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- gastrointestinal motility disorders;
- severe cardiovascular, pulmonary, hepatic, or renal dysfunction;
- HbA1c ≥8.0%;
- fasting plasma glucose >10.0 mmol/L at the preoperative assessment;
- malnutrition;
- known allergy to carbohydrate preparations;
- pregnancy or lactation;
- previous bariatric or gastrointestinal surgery;
- chronic use of medications known to substantially affect gastrointestinal motility.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: POC Group
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.
|
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.
|
|
Komparátor placeba: Control Group
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 non-caloric, carbohydrate-free clear liquid with a similar appearance and taste 2 hours before surgery.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
GI-3 recovery rate within 72 hours after surgery
Časové okno: 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.
|
Within 72 hours after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to GI-3 recovery
Časové okno: From the end of surgery up to 7 days after surgery.
|
From the end of surgery up to 7 days after surgery.
|
|
|
Time to GI-2 recovery
Časové okno: 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
|
From the end of surgery up to 7 days after surgery.
|
|
Postoperative Nausea and Vomiting Score
Časové okno: 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.
|
Days 1 - 4 postoperatively
|
|
15-item Quality of Recovery Score
Časové okno: 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.
|
Days 1 - 7 and 30 postoperatively
|
|
Perioperative blood glucose levels
Časové okno: Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
|
Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
|
|
|
Glycemic variability
Časové okno: Calculated based on blood glucose levels measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
|
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 to first postoperative flatus
Časové okno: From the end of surgery up to 7 days after surgery.
|
From the end of surgery up to 7 days after surgery.
|
|
|
Time to first postoperative defecation
Časové okno: From the end of surgery up to 7 days after surgery.
|
From the end of surgery up to 7 days after surgery.
|
|
|
Total length of hospital stay (including readmissions within 30 days after surgery)
Časové okno: Within 30 days after surgery
|
Within 30 days after surgery
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Unplanned readmission rate within 30 days after surgery
Časové okno: Within 30 days after surgery
|
Within 30 days after surgery
|
|
|
Postoperative complications
Časové okno: Within 30 days after surgery
|
Classified according to the Clavien-Dindo classification criteria for complications
|
Within 30 days after surgery
|
|
Gastric cross-sectional area (CSA)
Časové okno: Before anaesthetic induction
|
Calculated using the formula (AP × CC × π)/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter.
|
Before anaesthetic induction
|
|
Gastric volume
Časové okno: Before anaesthetic induction
|
= 27.0 + 14.6 × CSA - 1.28 × age
|
Before anaesthetic induction
|
|
Perlas grade
Časové okno: 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).
|
Before anaesthetic induction
|
|
Corrected gastric volume (CGV)
Časové okno: Before anaesthetic induction
|
Recalculated in mL kg-¹
|
Before anaesthetic induction
|
|
Incidence of regurgitation or aspiration
Časové okno: From anesthesia induction to discharge from the post-anesthesia care unit.
|
From anesthesia induction to discharge from the post-anesthesia care unit.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Wei Ke, PhD, First Affiliated Hospital of Chongqing Medical University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- POC-MetS-2026-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .