Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509466854555 Date of Registration: 10/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Gastric US with preoperative CHO loading in Morbidly obese patients
Official scientific title Gastric Ultrasound and Preoperative Oral Carbohydrate Loading in Morbidly Obese Patients: A Prospective Randomized Study
Brief summary describing the background and objectives of the trial Enhanced recovery pathways (ERPs) and recommendations have become widely accepted for metabolic and bariatric surgery, including recommendations for preoperative carbohydrate loading (L-CHO) and minimizing the duration of fasting status. The administration of clear oral carbohydrates 2 hours before surgery would pose a risk of aspiration if gastric emptying is delayed in patients with obesity. Gastric emptying studies using scintigraphy, which is considered the gold standard, showed no difference in gastric emptying times between obese and lean patient groups. Traditionally, patients fasted for extended periods before surgery to reduce anesthesia-related complications. However, this practice may paradoxically worsen perioperative metabolic disturbances. Preoperative carbohydrate-rich fluids may decrease both preoperative and postoperative thirst and hunger in all age groups. Moreover, many randomized controlled trials have demonstrated that L-CHO reduced the incidence of nausea and vomiting. In addition, current studies have reported that shortening the fasting period with preoperative oral CHO-rich solutions has a positive effect on postoperative stress and recovery by decreasing insulin resistance, sparing muscle proteins, and preserving immune system functions. Preoperative gastric ultrasound (G-US) imaging is an emerging modality that can be used to assess a patient’s gastric content when the aspiration risk is unclear. Gastric ultrasound imaging may be useful in situations where patients do not follow fasting guidelines, urgent procedures are necessary, delayed gastric emptying occurs due to significant comorbidities, or patients have unreliable medical histories. G-US can be used to evaluate the gastric volume in case of L-CHO, ensuring patient safety. In this study, the preoperative carbohydrate loading is investigated in terms of its impact on preoperative gastric volume (primary objective), gastric emptying, stress response, and patient satisfaction
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/09/2025
Actual trial start date
Anticipated date of last follow up 19/11/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Preoperative fasting group patients will follow the institutional fasting regimen, fasting for 8 hours. preoperative fasting for 8 hours. patients will follow the institutional fasting regimen, fasting for 8 hours. 26 Active-Treatment of Control Group
Experimental Group Preoperative carbohydrate loading group patients will follow the institutional fasting regimen, including fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery preoperative fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery patients will follow the institutional fasting regimen, including fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
morbidly obese patients (body mass index above 40) scheduled for elective surgery gastroesophageal reflux previous gastric surgery Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 07/09/2025 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome preoperative gastric volume measured by ultrasound immediately preoperatively
Secondary Outcome grading of gastric content as assessed by ultrasound  Grade 0 (empty stomach): If no content is visualized in the lateral decubitus position, the stomach is empty.  Grade 1 (low risk): If fluid content calculated to be less than 1.5 mL/kg, the patient is is at low risk for aspiration.  Grade 2 (high risk): If fluid content exceeds 1.5 mL/kg, the patient is considered at high risk for aspiration. immediately preoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals Geihan street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Elgomhoreya Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhoreya Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt assistant professor Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt assistant professor Mansoura Universuity
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymous IPD will be saved to an online depository and the link will be available after the study completion and publication, additional the data will be available 6 months after study completion upon contacting the principal investigator Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After 6 months from the actual study completion date * anonymous IPD ill be available 6 months after study completion upon contacting the principal investigator * The link to the IPD file saved to a data depository will be included in the manuscript after study publication.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 02/09/2025 as per PACTR recommendations Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/09/2025 as per PACTR recommendations Control Group, Group F, patients will follow the institutional fasting regimen, fasting for 8 hours., preoperative fasting for 8 hours., patients will follow the institutional fasting regimen, fasting for 8 hours., 26, Active-Treatment of Control Group Control Group, Preoperative fasting group, patients will follow the institutional fasting regimen, fasting for 8 hours., preoperative fasting for 8 hours., patients will follow the institutional fasting regimen, fasting for 8 hours., 26, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/09/2025 As per PACTR recommendations Experimental Group, Group L , patients will follow the institutional fasting regimen, including fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery, preoperative fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery, patients will follow the institutional fasting regimen, including fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery, 26, Experimental Group, Preoperative carbohydrate loading group, patients will follow the institutional fasting regimen, including fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery, preoperative fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery, patients will follow the institutional fasting regimen, including fasting for 8 hours except for receiving oral apple juice 200 ml 3 hours before planned surgery, 26,