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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Wei Ke, PhD
- Numero di telefono: +86 13883904332
- Email: wk202448@hospital-cqmu.com
Luoghi di studio
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Cina, 400016
- The First Affiliated Hospital of Chongqing Medical University（No. 1 Youyi Road, Yuzhong District, Chongqing 400016, China）
-
Contatto:
- Ren Li, PhD
- Numero di telefono: 8618323187421
- Email: renli177@163.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore placebo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
GI-3 recovery rate within 72 hours after surgery
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to GI-3 recovery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Within 30 days after surgery
|
Within 30 days after surgery
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Unplanned readmission rate within 30 days after surgery
Lasso di tempo: Within 30 days after surgery
|
Within 30 days after surgery
|
|
|
Postoperative complications
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Before anaesthetic induction
|
= 27.0 + 14.6 × CSA - 1.28 × age
|
Before anaesthetic induction
|
|
Perlas grade
Lasso di tempo: 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)
Lasso di tempo: Before anaesthetic induction
|
Recalculated in mL kg-¹
|
Before anaesthetic induction
|
|
Incidence of regurgitation or aspiration
Lasso di tempo: From anesthesia induction to discharge from the post-anesthesia care unit.
|
From anesthesia induction to discharge from the post-anesthesia care unit.
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Wei Ke, PhD, First Affiliated Hospital of Chongqing Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- POC-MetS-2026-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .