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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05442918




Registration number
NCT05442918
Ethics application status
Date submitted
26/06/2022
Date registered
5/07/2022

Titles & IDs
Public title
Expected Normal Ketone Values After Very Low and Bariatric Surgery
Scientific title
Expected Normal Ketone Values After Very Low and Bariatric Surgery
Secondary ID [1] 0 0
StVincentsMelbourne
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Ketoacidosis 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
General Surgery - All patients undergoing either elective laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair.

Bariatric Surgery - Participants undergoing elective bariatric surgery (laparoscopic sleeve gastrectomy or roux-en-y gastric bypass). Those in the bariatric arm must have been on a VLCD pre operatively

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood ketone
Timepoint [1] 0 0
Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week
Primary outcome [2] 0 0
Venous blood gas levels
Timepoint [2] 0 0
Immediately prior to surgery, immediately post-surgery, daily until discharge until up to 1 week

Eligibility
Key inclusion criteria
General surgery group, undergoing the following elective surgeries:

* laparoscopic/open cholecystectomy
* laparoscopic/open hiatus hernia repair
* laparoscopic/open inguinal hernia repair
* laparoscopic/open umbilical hernia repair
* laparoscopic ventral wall hernia repair

Bariatric surgery group, undergoing the following elective surgeries and a very low calorie diet before surgery:

* laparoscopic sleeve gastrectomy
* laparoscopic roux-en-y gastric bypass
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* currently on SLGT2 inhibitor
* non English speaking
* procedure abandoned

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Hii, FRACS
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.