Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001105336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/08/2026
Date registered
Help: Date registered
7/09/2026
Date last updated
Help: Date last updated
7/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/09/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Variation between and within surgeons in the size and shape of the stomach after weight-loss sleeve gastrectomy, measured on three-dimensional CT scans
Scientific title
Inter- and intra-surgeon variability in gastric anatomy following laparoscopic sleeve gastrectomy, assessed by three-dimensional computed tomography volumetry over time: a prospective longitudinal observational study
Additional trial identifiers [1] 318125 0
UGIS-SLEEVECT-2024
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Obesity managed with laparoscopic sleeve gastrectomy 343166 0
Condition category
Condition code
Diet and Nutrition 339251 339251 0 0
Obesity
Surgery 339252 339252 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
The three-dimensional CT (3D-CT) scans are research procedures. They are performed for this study at four timepoints — before surgery and at approximately 3 to 6 months, 12 to 18 months and 5 years after surgery — and in participants without reflux they are additional to usual clinical care and would not otherwise be undertaken. Each scan delivers an effective radiation dose of approximately 1.1 millisieverts. The sleeve gastrectomy itself is usual clinical care, chosen and performed on clinical grounds, and is not altered by the study.

Participants are adults with obesity undergoing laparoscopic sleeve gastrectomy as part of their usual clinical care, performed by any of approximately eight upper gastrointestinal surgeons at the study site. The study does not assign or alter the operation; each surgeon operates according to their usual technique. The exposure of interest is the operating surgeon and the sleeve gastrectomy procedure itself.

Standardised gastric anatomical measurements are made from the 3D-CT scans to quantify variation in stomach size and shape between different surgeons and within the same surgeon over time. No study treatment is assigned; all surgical and clinical care is delivered as usual care.
Intervention code [1] 335010 0
Diagnosis / Prognosis
Description of the comparator or control
The comparison is between surgeons (inter-surgeon variability in the size and shape of the constructed stomach) and within the same surgeon across their own cases and over time (intra-surgeon variability). Each participant also acts as their own control for changes in gastric anatomy over time, comparing pre-operative scans with post-operative scans. There is no separate control group.
Control group
Active

Outcomes
Primary outcome [1] 346490 0
Inter- and intra-surgeon variability in gastric anatomy after sleeve gastrectomy
Timepoint [1] 346490 0
Before surgery (baseline) and at approximately 3 to 6 months, 12 to 18 months, and 5 years after surgery.
Primary outcome [2] 346555 0
Gastric volume measured by 3D-CT volumetry
Timepoint [2] 346555 0
Before surgery (baseline) and at approximately 3 to 6 months, 12 to 18 months, and 5 years after surgery.
Primary outcome [3] 346556 0
Angularis surface area measured by 3D-CT
Timepoint [3] 346556 0
Before surgery (baseline) and at approximately 3 to 6 months, 12 to 18 months, and 5 years after surgery.
Secondary outcome [1] 466052 0
Percentage weight loss
Timepoint [1] 466052 0
At approximately 3 to 6 months, 12 to 18 months, and 5 years after surgery.
Secondary outcome [2] 466053 0
Gastro-oesophageal reflux symptoms
Timepoint [2] 466053 0
At approximately 3 to 6 months, 12 to 18 months, and 5 years after surgery.

Eligibility
Key inclusion criteria
Adults aged 18 years or older undergoing laparoscopic sleeve gastrectomy for obesity at the study site, who are able to provide written informed consent (including consent to the additional research CT scans).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Unable to provide informed consent; pregnancy, intention to become pregnant, or breastfeeding; contraindications to surgery; and declining the additional research CT scans.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of approximately 50 participants was chosen based on a comparable published 3D-CT gastric volumetry study (Pañella et al., 2020); a formal statistical power calculation is not applicable as this is a descriptive study of anatomical variability with no directly comparable prior data. Summary statistics will describe all anatomical variables. Continuous variables will be compared using t-tests, Wilcoxon rank-sum, one-way ANOVA and Kruskal-Wallis tests as appropriate; correlations will use Pearson or Spearman coefficients; and inter- and intra-surgeon variability will be assessed using intraclass correlation coefficients. Analyses will be performed in SPSS. Relationships between anatomical measurements and clinical outcomes will also be examined: post-operative gastric volume on 3D-CT against percentage weight loss, and anatomical features on 3D-CT (in particular the presence of hiatus hernia and sleeve stenosis) against patient-reported reflux and regurgitation symptoms measured with the Visick score. These associations are analyses of the outcomes listed in Step 4 rather than outcomes in themselves.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/06/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29963 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 46332 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 322675 0
Charities/Societies/Foundations
Name [1] 322675 0
Upper Gastrointestinal and Metabolic Research Foundation Ltd
Country [1] 322675 0
Australia
Primary sponsor type
Individual
Name
A/Prof Michael Talbot, St George Private Hospital
Address
Country
Australia
Secondary sponsor category [1] 325607 0
None
Name [1] 325607 0
Address [1] 325607 0
Country [1] 325607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321131 0
Ramsay Health Care Human Research Ethics Committee A
Ethics committee address [1] 321131 0
Ethics committee country [1] 321131 0
Australia
Date submitted for ethics approval [1] 321131 0
Approval date [1] 321131 0
18/12/2025
Ethics approval number [1] 321131 0
2024/ETH/0090

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

Contacts
Principal investigator
Name 152770 0
A/Prof Michael Talbot
Address 152770 0
Upper GI Surgery, St George Private Hospital, 1 South Street, Kogarah NSW 2217
Country 152770 0
Australia
Phone 152770 0
+61 2 9553 1120
Fax 152770 0
Email 152770 0
[email protected]
Contact person for public queries
Name 152771 0
Michael Talbot
Address 152771 0
Upper GI Surgery, St George Private Hospital, 1 South Street, Kogarah NSW 2217
Country 152771 0
Australia
Phone 152771 0
+61 2 9553 1120
Fax 152771 0
Email 152771 0
[email protected]
Contact person for scientific queries
Name 152772 0
Michael Talbot
Address 152772 0
Upper GI Surgery, St George Private Hospital, 1 South Street, Kogarah NSW 2217
Country 152772 0
Australia
Phone 152772 0
+61 2 9553 1120
Fax 152772 0
Email 152772 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Requests should be directed to the principal investigator and data custodian, A/Prof Michael Talbot, at [email protected].

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.