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Trial registered on ANZCTR


Registration number
ACTRN12618000337279
Ethics application status
Approved
Date submitted
26/02/2018
Date registered
6/03/2018
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Date results information initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ENdoscopIc Sleeve Gastroplasty Efficacy (ENvISaGE) Study in Obese Adults.
Scientific title
Weight loss efficacy, safety, and effect on comorbidity risk factors and quality of life of obese adults receiving Endoscopic Sleeve Gastroplasty (ESG) or Laparoscopic Sleeve Gastrectomy (LSG)
Secondary ID [1] 294164 0
None.
Universal Trial Number (UTN)
U1111-1216-8678
Trial acronym
ENvISaGE Study
Linked study record
None.

Health condition
Health condition(s) or problem(s) studied:
Obesity 306794 0
Condition category
Condition code
Surgery 305899 305899 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
After consultation with their proceduralist (gastroenterologist or surgeon), participants will select to undergo the ESG or the LSG.

The ESG will be performed as per standard practice by one of the Weight Loss Solutions Australia (WLSA) surgeons. Patients are placed under general anesthesia for the procedure. After measurement of the gastric volume via aesophagogastroduodenoscopy, anterior and posterior suture placement sites are mapped. A cap-based flexible endoscopic suturing system (OverStitch; Apollo Endosurgery, Austin, TX) is used to perform the procedure. The ESG is created by invaginating the greater curvature of the stomach for formation of the sleeve. The final result is a tubular reconficuration of the gastric lumen.
The Laparoscopic Sleeve Gastrectomy (LSG) will be peformed as per standard practice by one of the Weight Loss Solutions Australia (WLSA) surgeons. Patients are placed under general anesthesia for the procedure and local anesthetic is administered at all local trocar entrance sites. The abdominal cavity is accessed via a supraumbilical incision and using a trocar. Two staplers are used commencing at the pylorus up to the incisura angularis. The staple-line is inverted resulting in a gastric sleeve.


The patients will be followed from baseline to six-months post-procedure.
Intervention code [1] 300454 0
Not applicable
Comparator / control treatment
The ESG and LSG will not be compared for the primary outcomes related to weight change and will be reported prospectively according to the participants baseline.
The LSG will be the comparator for the ESG for secondary outcome variables.
Control group
Active

Outcomes
Primary outcome [1] 304938 0
Excess weight loss, kg (%)
Timepoint [1] 304938 0
6-months post-procedure
Primary outcome [2] 306678 0
Total body weight loss, kg (%)
Timepoint [2] 306678 0
12-months post-procedure
Secondary outcome [1] 343658 0
Adverse events: procedure-related complications (e.g. haemorrhage, gastric leak, abscess, stricture, organ failure, infection, death). Assessed by observation of the medical record.
Timepoint [1] 343658 0
2-weeks, 6-months & 12-months post-procedure.
Secondary outcome [2] 343659 0
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Timepoint [2] 343659 0
6-months & 12-months post-procedure
Secondary outcome [3] 343661 0
Body mass index (Kg/m2)
Timepoint [3] 343661 0
6-months & 12-months post-procedure
Secondary outcome [4] 343662 0
Fat mass, kg (via DXA)
Timepoint [4] 343662 0
6-months & 12-months post-procedure
Secondary outcome [5] 343663 0
Fat free mass (kg (via DXA)
Timepoint [5] 343663 0
6-months & 12-months post-procedure
Secondary outcome [6] 343664 0
Trunk mass, kg (via DXA)
Timepoint [6] 343664 0
6-months & 12-months post-procedure
Secondary outcome [7] 343665 0
Limb mass, kg (via DXA)
Timepoint [7] 343665 0
6-months & 12-months post-procedure
Secondary outcome [8] 343666 0
Systolic blood pressure, mmHg (via observation of the medical record).
Timepoint [8] 343666 0
6-months & 12-months post-procedure
Secondary outcome [9] 343667 0
Diastolic blood pressure, mmHg (via observation of the medical record).
Timepoint [9] 343667 0
6-months & 12-months post-procedure
Secondary outcome [10] 343668 0
Fasting blood glucose, mmol/L
Timepoint [10] 343668 0
6-months & 12-months post-procedure
Secondary outcome [11] 343669 0
HbA1c, % (via observation of the medical record).
Timepoint [11] 343669 0
6-months & 12-months post-procedure
Secondary outcome [12] 343670 0
Total cholesterol, mmol/L (via observation of the medical record).
Timepoint [12] 343670 0
6-months & 12-months post-procedure
Secondary outcome [13] 343671 0
LDL-cholesterol, mmol/L (via observation of the medical record).
Timepoint [13] 343671 0
6-months & 12-months post-procedure
Secondary outcome [14] 343672 0
HDL-cholesterol, mmol/L (via observation of the medical record).
Timepoint [14] 343672 0
6-months & 12-months post-procedure
Secondary outcome [15] 343673 0
Alanine Aminotransferase, U/L (via observation of the medical record).
Timepoint [15] 343673 0
6-months & 12-months post-procedure
Secondary outcome [16] 343674 0
Weight-related quality of life (Impact of Weight on Quality of Life Assessment Tool, IWQoL-Lite)
Timepoint [16] 343674 0
6-months & 12-months post-procedure
Secondary outcome [17] 343675 0
Allied health use (number and duration of appointments; via observation of the medical record)
Timepoint [17] 343675 0
12-months post-procedure

Eligibility
Key inclusion criteria
Plan for ESG or LSG procedure.
Aged 18 years or older.
Able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient reported expected unavailability for face-to-face appointment at 6- and/or 12-months post-procedure.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Participant, procedure and outcomes will be reported using descriptive statistics, and differences between groups at baseline will be tested for using chi-square for categorical variables or students t-test (or non-parametric equivalent if required) for continuous variables. Changes within each group for the primary and secondary outcomes from baseline to 6-month follow-up will be tested using chi-square or paired t-tests as appropriate. Secondary outcomes at 6-month up will be tested for significant differences between groups using chi-square and student-tests as appropriate.

Recruitment
Recruitment status
Active, not recruiting
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)
QLD

Funding & Sponsors
Funding source category [1] 298799 0
Government body
Name [1] 298799 0
Department of Industry, Innovation and Science
Address [1] 298799 0
Industry House
10 Binara Street
Canberra, ACT, 2600
Country [1] 298799 0
Australia
Funding source category [2] 298800 0
Commercial sector/Industry
Name [2] 298800 0
Weight Loss Solutions Australia
Address [2] 298800 0
Suite 3, Podium Level
Lakeside 1, 1 Lake Orr Drive
Varsity Lakes
QLD 4227
Country [2] 298800 0
Australia
Primary sponsor type
University
Name
Bond University
Address
University Drive,
Robina,
4226, Qld
Country
Australia
Secondary sponsor category [1] 297989 0
None
Name [1] 297989 0
Address [1] 297989 0
Country [1] 297989 0
Other collaborator category [1] 279962 0
Commercial sector/Industry
Name [1] 279962 0
Weight Loss Solutions Australia
Address [1] 279962 0
Suite 3, Podium Level
Lakeside 1, 1 Lake Orr Drive
Varsity Lakes
QLD 4227
Country [1] 279962 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299745 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 299745 0
Research Services
Building 1C, Level 4
Bond University QLD 4229
Ethics committee country [1] 299745 0
Australia
Date submitted for ethics approval [1] 299745 0
17/01/2018
Approval date [1] 299745 0
23/02/2018
Ethics approval number [1] 299745 0
SM02936

Summary
Brief summary
A new type of procedure for managing obesity has recently become available in Australia: Endoscopic Sleeve Gastroplasty (ESG), which stimulates weight loss by reducing gastric volume. Unlike the widely implemented laparoscopic sleeve gastrectomy (LSG), the less invasive and incisionless ESG is performed endoscopically and trans-orally. Therefore, the ESG will reduce surgery-related complications and recovery time. Therefore, a non-inferiority prospective cohort study will be undertaken to determine the weight loss efficacy, safety, and effect on comorbidity risk factors and quality of life of obese adults receiving Endoscopic Sleeve Gastroplasty (ESG) compared with Laparoscopic Sleeve Gastrectomy (LSG). 106 participants will be consecutively recruited from Weight Loss Solutions Australia on the Gold Coast. The primary outcome will be excess weight loss at 6-months post-procedure, and secondary outcomes will examine body composition (via DXA), quality of life, complications related to the procedure, lipid profile, blood pressure, comorbidities, blood pressure, and allied health use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81438 0
Prof Elizabeth Isenring
Address 81438 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 81438 0
Australia
Phone 81438 0
+6175595 3337
Fax 81438 0
Email 81438 0
lisenrin@bond.edu.au
Contact person for public queries
Name 81439 0
Prof Elizabeth Isenring
Address 81439 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 81439 0
Australia
Phone 81439 0
+61755953337
Fax 81439 0
Email 81439 0
lisenrin@bond.edu.au
Contact person for scientific queries
Name 81440 0
Prof Elizabeth Isenring
Address 81440 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, 4226 Qld
Country 81440 0
Australia
Phone 81440 0
+61755953337
Fax 81440 0
Email 81440 0
lisenrin@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
this study does not have ethical approval to share data
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary