Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000952246
Ethics application status
Approved
Date submitted
3/05/2018
Date registered
6/06/2018
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does having a Minimizer Ring help prevent the stomach stretching and weight regain after a sleeve gastrectomy?
Scientific title
The efficacy of the Minimizer Ring in preventing sleeve dilatation and weight regain (total weight loss) after a primary laparoscopic sleeve gastrectomy, and its effect on complication rate, de novo reflux and food tolerance.
Secondary ID [1] 294703 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 307570 0
Condition category
Condition code
Surgery 306640 306640 0 0
Surgical techniques
Metabolic and Endocrine 306787 306787 0 0
Diabetes
Diet and Nutrition 306788 306788 0 0
Obesity
Musculoskeletal 306789 306789 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the placement of a Minimizer Ring (a silicone ring) at the time of a laparoscopic sleeve gastrectomy (LSG). The ring is placed by a bariatric surgeon with approximately 10 years experience at performing LSGs and approximately 4.5 years experience of placing the Minimizer Ring. The ring is placed around the sleeve (stomach remnant) immediately after the excised stomach is removed during a LSG thus in surgical theatre under a general anaesthesia. Patients will be randomised into two goups - one that recieves the ring and one that does not. The ring is placed loosely around the sleeve at a typical diameter of 8cm. If the ring cannot be fixed loosely, it will not be placed. Currently this is a rare occurrence. The progress of all patients will then be monitored for 3 years after surgery.
Intervention code [1] 301013 0
Treatment: Devices
Comparator / control treatment
The control group will consist of patients who undergo a LSG without the silicone ring placed.
Control group
Active

Outcomes
Primary outcome [1] 305661 0
Total percentage weight loss (kg) measured on a digital scale.
Timepoint [1] 305661 0
6mo, 12mo, 18mo, 24mo, 30mo and 36mo (primary time-point) post-LSG
Secondary outcome [1] 346069 0
Sleeve (stomach volume cm3) as measured by a CT Fizzogram
Timepoint [1] 346069 0
Three years post-LSG
Secondary outcome [2] 346070 0
The presence of reflux as measured by a pH nasopharyngeal probe.
Timepoint [2] 346070 0
Three years post-LSG
Secondary outcome [3] 346071 0
Symptoms of reflux as measured by GSAS (reflux) questionnaire
Timepoint [3] 346071 0
Pre-surgery (when the patient presents to clinic to sign the surgical consent), 6mo, 12mo, 18mo, 24mo, 30mo and 36mo post-LSG.
Secondary outcome [4] 346072 0
Food tolerance score as measured by Suter (food tolerance) questionnaire
Timepoint [4] 346072 0
6mo, 12mo, 18mo, 24mo, 30mo and 36mo post-LSG

Eligibility
Key inclusion criteria
Patients eligible for a primary LSG aged 18-65yrs and who present to the clinic without already having determined if they do or do not wish to have a Minimizer Ring placed.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who cannot attend appointments primarily due to geographical restraints eg. live remotely and do not visit Perth regularly

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central concealed randomisation by computer software and pair-matched for gender and age-quartile.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pair-matched by gender and age quartile (18-30; 30-40; 40-50; 50-65yrs) computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
25/06/2018
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
5/12/2022
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10788 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [2] 10789 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 22528 0
6008 - Subiaco
Recruitment postcode(s) [2] 22527 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 299688 0
Commercial sector/Industry
Name [1] 299688 0
Obesity Surgery WA
Country [1] 299688 0
Australia
Primary sponsor type
Individual
Name
Ass. Prof. Harsha Chandraratna
Address
Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 298577 0
Individual
Name [1] 298577 0
Prof. Eli Gabbay
Address [1] 298577 0
Respiratory West
1/178 Cambridge Street,
Wembley, WA 6014
Country [1] 298577 0
Australia
Secondary sponsor category [2] 298664 0
Individual
Name [2] 298664 0
Prof. Joe Proietto
Address [2] 298664 0
The University of Melbourne
Parkville, Victoria 3010
Country [2] 298664 0
Australia
Other collaborator category [1] 280089 0
Individual
Name [1] 280089 0
Angela Houston
Address [1] 280089 0
Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150
Country [1] 280089 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300218 0
University Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 300218 0
23 High Street, Fremantle, WA 6160
Ethics committee country [1] 300218 0
Australia
Date submitted for ethics approval [1] 300218 0
15/05/2018
Approval date [1] 300218 0
24/07/2018
Ethics approval number [1] 300218 0
018059F
Ethics committee name [2] 300234 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 300234 0
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
Ethics committee country [2] 300234 0
Australia
Date submitted for ethics approval [2] 300234 0
29/06/2018
Approval date [2] 300234 0
Ethics approval number [2] 300234 0

Summary
Brief summary
The laparoscopic sleeve gastrectomy (LSG) is currently the most commonly performed bariatric procedure in Australia. Long-term data is beginning to appear in the literature and indicates that up to half of patients who have undergone the surgery regain a significant amount of weight in the years following the surgery. These patients often progress to have further surgery to promote more weight loss. In some patients, the regain in weight is thought to be caused by the stomach stretching in size and the patient can then eat more again. Some surgeons have started placing a silastic ring around the stomach with the original surgery to prevent the stomach from stretching. Long-term data on the efficacy and safety of inserting a ring with a sleeve gastrectomy is scarce. It is also possible that a ring may have an effect on reflux and what foods a person can tolerate.
This study will be a randomised prospective study with the purpose of evaluating the efficacy of a silastic ring in preventing sleeve dilatation (stomach stretching) and deduce any effect on complication rate; reflux; and food tolerance. The study will provide three-year data to assist in determining whether a banded LSG (using a ring) should become the preferred surgical option for the treatment of obesity.
Approximately 95 patients who undergo a banded LSG and 95 patients who receive a standard LSG will be followed for a period of thirty-six months. Patients will be randomised into one of the two study groups. Anthropometric and metabolic data will be collected pre-operative, and at 6, 12, 24 and 36 months after surgery. Food tolerance and reflux evaluated . Stomach capacity will be measured by a Computerised Tomography (CT) Fizzogram at 36 months post-operative. Participants will be asked to have a nasopharyngeal 24 hr pH probe placed at 36 months’ post-operatively irrespective of symptoms as per current clinical practice.
Patients presenting before 36 months with weight regain and /or symptomatic reflux will have a CT Fizzogram or oropharyngeal pH monitoring performed earlier, as per normal clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82950 0
Ms Angela S Houston
Address 82950 0
Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150
Country 82950 0
Australia
Phone 82950 0
+61893320066
Fax 82950 0
Email 82950 0
oswa.dietitian@gmail.com
Contact person for public queries
Name 82951 0
Ms Angela S Houston
Address 82951 0
Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150
Country 82951 0
Australia
Phone 82951 0
+61893320066
Fax 82951 0
Email 82951 0
oswa.dietitian@gmail.com
Contact person for scientific queries
Name 82952 0
A/Prof Harsha Chandraratna
Address 82952 0
Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150
Country 82952 0
Australia
Phone 82952 0
+61893320066
Fax 82952 0
Email 82952 0
drchandra@westnet.com.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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