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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
Date last updated
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
15/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2020
Sample size
Target
Accrual to date
Final
55
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
The investigators propose a multicenter prospective study in patients undergoing either an elective bariatric procedure or an elective benign procedure, including laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair. Perioperative blood ketone and venous blood gas levels will be measured pre-surgery, post-surgery and on post-operative days until discharge.

Our primary research objective is to clarify the expected perioperative ketone and blood gas levels in elective bariatric patients who have been on a VLCD and fasting for surgery, compared to elective surgical patients who have only been fasting prior to surgery.
Trial website
https://clinicaltrials.gov/study/NCT05442918
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05442918