NCT06543615

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 7, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

August 5, 2024

Last Update Submit

May 6, 2025

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

  • residual gastric volume

    Measurement of residual gastric volume immediately preoperative in right lateral decubitus after fasting 8 hours

    After fasting 8 hours immediately preoperative

Secondary Outcomes (1)

  • incidence of aspiration

    Perioperative ( immediately preoperative, intraoperative or during recovery from anesthesia post operative

Study Arms (2)

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

Device: Ultrasonography

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

Device: Ultrasonography

Interventions

UltrasonographyDEVICE

Ultrasound assessment of residual gastric volume

Patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomyPatients undergoing laparoscopic cholecystectomy with no history of bariatric surgeries

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine ain shams university

Cairo, Cairo Governorate, Egypt

Location

Related Publications (4)

  • Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.

    PMID: 30443057BACKGROUND

  • Walter U, Loong C, Loewenhaupt M, Schlabitz W. Evidence of a magnetic gaplike excitation in URu2Si2. Phys Rev B Condens Matter. 1986 Jun 1;33(11):7875-7878. doi: 10.1103/physrevb.33.7875. No abstract available.

    PMID: 9938176BACKGROUND

  • Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

    PMID: 29624530BACKGROUND

  • Steenackers N, Vanuytsel T, Augustijns P, Deleus E, Deckers W, Deroose CM, Falony G, Lannoo M, Mertens A, Mols R, Vangoitsenhoven R, Wauters L, Van der Schueren B, Matthys C. Effect of sleeve gastrectomy and Roux-en-Y gastric bypass on gastrointestinal physiology. Eur J Pharm Biopharm. 2023 Feb;183:92-101. doi: 10.1016/j.ejpb.2022.12.018. Epub 2023 Jan 2.

    PMID: 36603693BACKGROUND

MeSH Terms

Conditions

Fasting

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 9, 2024

Study Start

January 1, 2025

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

May 7, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)