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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Surgery

Surgical techniques

Metabolic and Endocrine

Diabetes

Diet and Nutrition

Obesity

Musculoskeletal

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]

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]

Total percentage weight loss (kg) measured on a digital scale.

Timepoint [1]

6mo, 12mo, 18mo, 24mo, 30mo and 36mo (primary time-point) post-LSG

Secondary outcome [1]

Sleeve (stomach volume cm3) as measured by a CT Fizzogram

Timepoint [1]

Three years post-LSG

Secondary outcome [2]

The presence of reflux as measured by a pH nasopharyngeal probe.

Timepoint [2]

Three years post-LSG

Secondary outcome [3]

Symptoms of reflux as measured by GSAS (reflux) questionnaire

Timepoint [3]

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]

Food tolerance score as measured by Suter (food tolerance) questionnaire

Timepoint [4]

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?

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)

Recruitment hospital [1]

St John of God Hospital, Murdoch - Murdoch

Recruitment hospital [2]

St John of God Hospital, Subiaco - Subiaco

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Obesity Surgery WA

Address [1]

Suite 27, Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150

Country [1]

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]

Individual

Name [1]

Prof. Eli Gabbay

Address [1]

Respiratory West
1/178 Cambridge Street,
Wembley, WA 6014

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Prof. Joe Proietto

Address [2]

The University of Melbourne
Parkville, Victoria 3010

Country [2]

Australia

Other collaborator category [1]

Individual

Name [1]

Angela Houston

Address [1]

Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University Notre Dame Australia Human Research Ethics Committee

Ethics committee address [1]

23 High Street, Fremantle, WA 6160

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2018

Approval date [1]

24/07/2018

Ethics approval number [1]

018059F

Ethics committee name [2]

St John of God Health Care Human Research Ethics Committee

Ethics committee address [2]

C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

29/06/2018

Approval date [2]

Ethics approval number [2]

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

Ms Angela S Houston

Address

Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150

Country

Australia

Phone

+61893320066

Fax

[email protected]

Contact person for public queries

Name

Angela S Houston

Address

Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150

Country

Australia

Phone

+61893320066

Fax

[email protected]

Contact person for scientific queries

Name

Harsha Chandraratna

Address

Obesity Surgery WA, Suite 27 Murdoch Medical Centre, 100 Murdoch Dve, Murdoch WA 6150

Country

Australia

Phone

+61893320066

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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