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Trial registered on ANZCTR


Registration number
ACTRN12625000796482
Ethics application status
Approved
Date submitted
16/06/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of gastric surgeries (anti-reflux or bariatric) on symptoms and gastric activity using Gastric Alimetry in patients indicated for gastric surgery
Scientific title
The effect of gastric surgeries (anti-reflux or bariatric) on symptoms and gastric activity using Gastric Alimetry in patients indicated for gastric surgery
Secondary ID [1] 314649 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic gastrointestinal symptoms following anti-reflux or bariatric surgery 337813 0
Gastric dysmotility 337814 0
Abnormal gastric myoelectrical activity 337815 0
Post-surgical functional gastrointestinal disorders 337816 0
Condition category
Condition code
Oral and Gastrointestinal 334155 334155 0 0
Normal oral and gastrointestinal development and function
Oral and Gastrointestinal 334156 334156 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective observational cohort study. The exposure is gastric surgery (anti-reflux or bariatric), undertaken as part of standard clinical care. The study will observe changes in gastric function and symptoms before and after surgery.

Participants would not have routine clinical access to body surface gastric mapping (BSGM) outside of research; however, they may be able to undergo BSGM in other clinical studies run by Alimetry (longitudinal study). Access to BSGM is not limited solely to this study but is available through participation in approved research protocols.

The Gastric Alimetry device is a non-invasive test applied to the upper abdomen (stomach region) using a flexible array containing 64 electrodes adhered to the skin. Participants recline comfortably during the ~4.5-hour test, which captures high-resolution gastric myoelectrical activity along with real-time symptom logging. (Refer to the attached protocol for full procedural details.)
Procedures and activities include:

Participants will undergo body surface gastric mapping (BSGM) using the Gastric Alimetry device. This is a non-invasive test lasting approximately 4.5 hours. The baseline BSGM will be performed 1–30 days prior to the planned surgery.

Participants will complete validated questionnaires at baseline, 6 months, and 12 months. These include GCSI, PAGI-SYM, PAGI-QOL, EQ-5D, STAI-6, PHQ-8, GAD7, PSS4, and possibly the GCSI Daily Diary Symptom scale.

BSGM will be repeated at 6 months post-surgery

Medical records will be reviewed to confirm clinical history and surgery details.

Delivery and personnel:

The BSGM test and questionnaire administration will occur face-to-face and individually at the Macarthur Clinical School, Western Sydney University.

Trained clinical research staff or medical students under supervision will conduct the assessments.

Surgery will be performed independently by the treating surgical teams as per standard care at affiliated hospitals.

For the purposes of this study, standard care is defined as the routine clinical management of patients undergoing gastric surgery (anti-reflux or bariatric) by their treating surgical teams. This includes the usual pre-operative assessment, the surgical procedure performed according to standard hospital protocols, and post-operative follow-up as determined by the treating clinician. The study is observational only and will not alter or influence the clinical care pathway or surgical decision-making.

Duration of observation:

Each participant will be followed for up to 12 months post-surgery.
Intervention code [1] 331278 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.

This is an observational study assessing changes in gastric function and symptoms before and after standard-of-care gastric surgery (anti-reflux or bariatric) without a comparator or control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341809 0
Change in BSGM metrics after surgery compared to baseline
Timepoint [1] 341809 0
Baseline, 6-month after the surgery
Secondary outcome [1] 448756 0
Proportion of patients with BSGM abnormalities after surgery
Timepoint [1] 448756 0
6-month after the surgery
Secondary outcome [2] 450020 0
Symptom severity
Timepoint [2] 450020 0
30 days, 90 days, 6 months, 12 months post surgery
Secondary outcome [3] 450022 0
Quality of Life
Timepoint [3] 450022 0
30 days, 90 days, 6 months, 12 months post surgery
Secondary outcome [4] 450023 0
Psychometric Measures
Timepoint [4] 450023 0
30 days, 90 days, 6 months, 12 months post surgery

Eligibility
Key inclusion criteria
- 18 years old
- Indicated for a gastric surgery (anti-reflux or bariatric)
- Can give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breast-feeding
- Inability to perform BSGM test: history of severe skin allergies or sensitivity to adhesives, cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Correlation between change in BSGM metrics and symptoms will be assessed using Pearson’s correlation coefficient.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319213 0
Government body
Name [1] 319213 0
Health Research Council of New Zealand
Country [1] 319213 0
New Zealand
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 321681 0
None
Name [1] 321681 0
Address [1] 321681 0
Country [1] 321681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317793 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 317793 0
Ethics committee country [1] 317793 0
Australia
Date submitted for ethics approval [1] 317793 0
01/08/2022
Approval date [1] 317793 0
01/11/2022
Ethics approval number [1] 317793 0

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

Contacts
Principal investigator
Name 142170 0
Dr Vincent Ho
Address 142170 0
Campbelltown Hospital, Therry Rd, Campbelltown NSW 2560
Country 142170 0
Australia
Phone 142170 0
+61 2 4634 4001
Fax 142170 0
Email 142170 0
[email protected]
Contact person for public queries
Name 142171 0
Dr Madhuri Venigalla
Address 142171 0
Macarthur Clinical School, Parkside Cres, Campbelltown NSW 2560
Country 142171 0
Australia
Phone 142171 0
+61 2 4634 4579
Fax 142171 0
Email 142171 0
[email protected]
Contact person for scientific queries
Name 142172 0
Dr Madhuri Venigalla
Address 142172 0
Macarthur Clinical School, Parkside Cres, Campbelltown NSW 2560
Country 142172 0
Australia
Phone 142172 0
+61 2 4634 4579
Fax 142172 0
Email 142172 0
[email protected]

Data sharing statement
Will the study consider sharing 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.