Actively Recruiting

Age: 18Years - 65Years
All Genders
ID07032207

Correlation of Gastric Residual Volume by Preoperative Gastric Ultrasound With Body Mass Index and Aspiration Risk in Patients Undergoing Laparoscopic Bariatric Surgery

Led by Fatih Sultan Mehmet Training and Research Hospital · Updated on 2025-06-22

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obesity is a chronic and complex disease characterized by excessive body fat that can harm health. This research investigates the relationship between body mass index (BMI), fasting duration, and the risk of aspiration by measuring gastric residual volume using gastric ultrasonography in obese patients undergoing laparoscopic bariatric surgery. The study focuses on patients with BMI over 35 kg/m², as obesity increases the risk of complications like delayed gastric emptying and pulmonary aspiration during anesthesia. Before surgery, participants will receive gastric ultrasonography in two positions to measure stomach contents and calculate gastric residual volume, which helps assess aspiration risk. Patients will then undergo standard anesthesia and bariatric surgery with careful monitoring of anesthesia depth and vital signs. Postoperative care includes pain management and nausea evaluation. The study also collects detailed clinical data, including lab tests and medical history. Participants will be closely monitored throughout the surgery and recovery. Researchers will record aspiration events, surgical duration, and postoperative nausea severity at multiple time points. The primary focus is on correlating BMI with gastric residual volume and aspiration risk, while also examining fasting duration's effect. The total involvement includes preoperative assessment, surgery, and postoperative follow-up to evaluate safety and outcomes in this patient group.

CONDITIONS

Brief Title

Correlation of Preoperative Gastric Residual Volume With Body Mass Index and Aspiration Risk in Laparoscopic Bariatric Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective bariatric surgery under general anesthesia
  • Age between 18 and 65 years
  • Body mass index (BMI) greater than 35 kg/m²
  • ASA physical status classification II or III
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Age under 18 or over 65 years
  • ASA physical status classification IV or V
  • Pregnancy
  • Upper gastrointestinal abnormalities such as hiatal hernia or gastric tumors
  • Recent upper gastrointestinal bleeding within the last 12 months
  • Previous stomach or esophagus surgeries or abnormal upper GI anatomy
  • Use of medications affecting gastric motility
  • Uncontrolled diabetes
  • Emergency surgery requirement
  • Advanced cardiac, renal, pulmonary, or hepatic failure
  • Refusal to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility confirmation

Diagnostic Evaluation

Duration - 1 day

Participants undergo preoperative gastric ultrasonography to measure gastric residual volume and assess aspiration risk before laparoscopic bariatric surgery.

1 visit (in-person) on the day of surgery before anesthesia

Surgery and Immediate Post-operative Care

Duration - Surgery day

Participants receive laparoscopic bariatric surgery under general anesthesia with monitoring of perioperative aspiration events and standard anesthesia care.

1 visit (in-person) on the day of surgery

Post-operative Follow-up

Duration - 24 hours

Participants are monitored for postoperative nausea and complications up to 24 hours after surgery.

3 visits (in-person) at 1, 6, and 24 hours post-surgery

Trial Site Locations

Total: 1 location

1

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34752

Actively Recruiting

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Research Team

B

BUSRA TANACIOGLU, Research Assistant M.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Point-of-Care Ultrasound to Assess Gastric Content in Pediatric Emergency Department Procedural Sedation Patients.

Matthew M Moake, Bradley C Presley, Jeanne G Hill...

https://pubmed.ncbi.nlm.nih.gov/32769837

Prevalence and factors predictive of full stomach in elective and emergency surgical patients: a prospective cohort study.

L Bouvet, F-P Desgranges, C Aubergy...

https://pubmed.ncbi.nlm.nih.gov/28203726

Comparative evaluation of gastric pH and volume in morbidly obese and lean patients undergoing elective surgery and effect of aspiration prophylaxis.

Vikram Mahajan, Junaid Hashmi, Rahil Singh...

https://pubmed.ncbi.nlm.nih.gov/25935831