Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy

May 6, 2025 updated by: Ain Shams University

Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy : Comparative Study With Patients Without History of Bariatric Surgeries

Preoperative US assessment of residual gastric volume in both; patients with previous laparoscopic sleeve gastrectomy and those without history of bariatric surgeries, undergoing elective laparoscopic cholecystectomy, aiming to develop a step for recommendations for fasting guidelines

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

No doubt, that perioperative aspiration of gastric content during anesthesia process is every anesthesiologist's nightmare, which can lead to serious morbidities and mortalities with a rate of 5% to 9 % in anesthesia airway management accidents.

Risk of aspiration usually present during induction of anesthesia due to passive regurgitation during endotracheal intubation while it may occur during recovery from anesthesia in patients with active vomiting.

It is known that the volume of residual gastric content is one of the most important factors that can lead to significant increase in the risk of perioperative pulmonary aspiration, acknowledging this fact, lead the American society of Anesthesiology (ASA) to recommend for eight hours fasting for solids (fats and/or meats), six hours for non-human milk and light meals, and two hours for clear fluids, to reduce residual gastric volume and subsequently the risk of perioperative aspiration.

There are many different ways to asses gastric content for example nasogastric tube aspiration of gastric content which is an invasive technique. Other ways include imaging tools like abdominal CT scan which is not easily done and will have extra cost on the patient . In addition, wireless motility capsules and gastric emptying scintigraphy can be used but all of them are not suitable for routine assessment.

On the other hand Point-of-Care (POC) ultrasound usage in anesthesia management has provided a wide range of rapid, bed side and non-invasive, easy and fast techniques that help to reduce the risk of morbidity and mortality. It also, helped to provide a technique for qualitative and quantitative assessments of residual gastric contents preoperatively through gastric antrum US assessment using measurement of the antral cross-sectional area.

In the past it was believed that gastric content more than 2.5 ml/kg was considered as an "at risk" stomach volume , but nowadays several studies using ultrasonography assessment of residual gastric content indicated that the accepted volume should be less than 1.5 ml/kg in healthy fasting adult to define an empty stomach.

It is well known that bariatric surgeries nowadays became very popular among patients suffering from obesity for the sake of better quality of life specially sleeve gastrectomy and Roux-en-Y gastric bypass surgeries. A statistical study was done among the American population in 2018 reported that about 252 000 bariatric procedures are being performed every year and the number is rising by time specially with advanced surgical techniques that reduced the complications of these types of surgeries. However; no statistics has been released for Egyptian population.

As regards, Nele, et. al. reported that gastric emptying was significantly reduced in patients with history of sleeve gastrectomy and Roux-en-Y gastric bypass surgeries as compared to obese patients by comparing gastric emptying scintigraphy, wireless motility capsule and gastrointestinal fluid aspiration techniques.

Also Eric, et al. in their meta-analysis study, have reported that gastric emptying time was reduced after gastric bypass surgery but it was constant or increased with endoscopically inserted intragastric balloons.

Many studies tried to asses changes in GIT physiology after bariatric surgeries including gastric emptying time using several methods as mentioned before but less frequently ultrasound guided assessment.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Faculty of medicine ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Two groups both undergoing laparoscopic cholecystectomy the first group with history of laparoscopic sleeve gastrectomy, while the second group with No history of previous bariatric surgeries according to inclusion and exclusion criteria

Description

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists physical status classification) I-II
  • Aged between 21 and 45 years old undergoing elective surgery.
  • Fasting 8 hours preoperative.
  • Body mass index less than 35 Kg/m2

Exclusion Criteria:

  • ASA physical status more than II .
  • Pregnant women.
  • Patients above 45 years and below 21 years.
  • History of drug intake of prokinetics or any drug that affect gastric emptying and/or motility.
  • Diabetic patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy
Gastric residual volume will be assessed after 8 hours of fasting preoperatively using ultrasonography in patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy
Ultrasound assessment of residual gastric volume
Patients undergoing laparoscopic cholecystectomy with no history of bariatric surgeries
Gastric residual volume will be assessed after 8 hours of fasting preoperatively using ultrasonography in patients undergoing laparoscopic cholecystectomy with No history of bariatric surgeries
Ultrasound assessment of residual gastric volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
residual gastric volume
Time Frame: After fasting 8 hours immediately preoperative
Measurement of residual gastric volume immediately preoperative in right lateral decubitus after fasting 8 hours
After fasting 8 hours immediately preoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of aspiration
Time Frame: Perioperative ( immediately preoperative, intraoperative or during recovery from anesthesia post operative
Documentation of aspiration incidence immediately preoperative, intraoperative or during recovery from anesthesia post operative
Perioperative ( immediately preoperative, intraoperative or during recovery from anesthesia post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Fasting required preoperative

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe