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Trial registered on ANZCTR


Registration number
ACTRN12622000560796
Ethics application status
Approved
Date submitted
7/01/2022
Date registered
12/04/2022
Date last updated
12/04/2022
Date data sharing statement initially provided
12/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Laparoscopic silastic ring Roux -En-Y gastric bypass versus duodenal switch as revisional procedures following sleeve gastrectomy
Scientific title
Laparoscopic silastic ring Roux -En-Y gastric bypass versus duodenal switch as revisional procedures following sleeve gastrectomy: A Prospective, Randomized Controlled Non-Inferiority Trial
Secondary ID [1] 303687 0
Nil
Universal Trial Number (UTN)
U1111-1226-6880
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 321090 0
Condition category
Condition code
Diet and Nutrition 318892 318892 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Roux en y gastric bypass (RYGB) with silastic ring. Performed laparoscopically with a 150cm biliopancreatic (BP) limb and a 100cm Roux limb. A silastic ring will be applied mid gastric pouch as in standard for RYGB in our unit. The operation usually takes 2 hours to perform. Patients are given ethics approved patient information sheet outlining the operation, risks involved, expected short term and long term outcomes. Patients also attend a 1 hour information seminar delivered by a fellowship trained bariatric surgeon with our specialised bariatric nurse specialists and bariatric dietitians also present to answer questions. 1 hour online dietitian group sessions are performed pre-operatively as well as 1 hour pre-operative bariatric nurse specialist assessment and at least two preoperative 45 minute clinical assessments by the bariatric surgeons. Timing of preoperative appointments relative to surgery varies according to theatre list availability.
The intervention is delivered in the operating theatre as a single stage operation by experienced fellowship trained bariatric surgeons.
Intervention code [1] 322552 0
Treatment: Surgery
Comparator / control treatment
Duodenal switch. This is perfomed laparoscopically with an ailimentary limb of 40% small bowel length and a common channel of 10% total small bowel length (minimum length 100cm) and a biliopancreatic limb of 50% small bowel length. Patients are given ethics approved patient information sheet outlining the operation, risks involved, expected short term and long term outcomes. the expected duration of the operation is 3 to 3.5 hours. Patients also attend a 1 hour information seminar delivered by a fellowship trained bariatric surgeon with our specialised bariatric nurse specialists and bariatric dietitians also present to answer questions. 1 hour online dietitian group sessions are performed pre-operatively as well as 1 hour pre-operative bariatric nurse specialist assessment and at least two preoperative 45 minute clinical assessments by the bariatric surgeons. Timing of preoperative appointments relative to surgery varies according to theatre list availability.
The intervention is delivered in the operating theatre as a single stage operation by experienced fellowship trained bariatric surgeons.
Control group
Active

Outcomes
Primary outcome [1] 330040 0
Percentage excess weight loss measure on specialised bariatric digital scales at time of clinic follow-up. This is measured by our bariatric clinic nurses and recorded in the patients digital record. Percentage excess weight is calculated as the weight above the body weight require for a BMI of 25.
Timepoint [1] 330040 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [1] 404698 0

Hyperlipidaemia using fasting lipid blood test
Timepoint [1] 404698 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [2] 404699 0
Patient satisfaction using validated quality of life outcome measures;
Bariatric Analysis and Reporting Outcome System (BAROS)
Timepoint [2] 404699 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [3] 408316 0
Hypertension using blood pressure assessment at time of clinic follow-up
Timepoint [3] 408316 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [4] 408317 0
Type 2 diabetes remission using HBA1c blood test
Timepoint [4] 408317 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [5] 408318 0
Patient satisfaction using validated quality of life outcome measures using - Gastroesophageal reflux disease questionaire (GERDQ)
Timepoint [5] 408318 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [6] 408319 0
Patient satisfaction using validated quality of life outcome measures using - Gastrointestinal Quality of Life Index (GIQLI)
Timepoint [6] 408319 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [7] 408320 0
Patient satisfaction using validated quality of life outcome measures using - Short Form 36 (SF-36) questionnaire
Timepoint [7] 408320 0
Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
Secondary outcome [8] 408579 0
Post-operative complications as a composite score graded according to Clavien-Dindo classification.
Timepoint [8] 408579 0
Intra-operative and post-operative complications evaluated to 90 days post-operatively.
These are assessed from patient records during initial post-operative stay, during any readmission and during the initial post operative follow-up. All patients have 3 monthly clinic follow-up for the first year.

Eligibility
Key inclusion criteria
previous sleeve gastrectomy (at least 24 months prior) and
Weight greater than 45kg above the ideal body weight for sex, and height.
BMI >; 40 by itself or >35 if there is an associated obesity illness , such as diabetes or
sleep apnoea
Reasonable attempts at other weight loss techniques
Age 18-65yrs
Obesity related health problems
No psychiatric or drug dependency problems
A capacity to understand the risks and commitment associated with the surgery.
Pregnancy not anticipated in the first two years following surgery
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smoker
Current drug or alcohol abuse
Pregnancy
Malabsorptive or inflammatory bowel disease
Unstable psychiatric disorder

History of chronic pancreatitis or idiopathic acute pancreatitis.
Severe cardiorespiratory disease or other conditions contraindicating anaesthesia
Active malignancy
Patients with severe reflux oesophagitis or Barrett’s oesophagus
Patients grossly dilated or strictured gastric sleeves

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 computerised randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation with minimisation based on age, body mass
index, ethnicity and diabetic status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
From bariatric literature a difference 10-15% EWL is often reported as clinically relevant. A difference of 15% EWL has also been reported to have a significant impact of quality of life and was therefore chosen as the non-inferiority limit.
Sample size
According to the case-matched trial of duodenal switches performed for weight regain or insufficient weight loss by Biertho et al. (1) the mean EWL in the conversion to DS group at 2 years was 80.2 ± 17%. Based on these results, the null hypothesis is that there exits inferiority of RYGB compared to DS in EWL 24 months after surgery. Based on the assumption that a difference in EWL of 15 % as noted in literature above is clinically relevant. The power calculation for a non-inferiority trial with a one-sided t-test (alpha=.025 % and beta=20 %) and a standard deviation of 17 % revealed that 21 patients per intervention group need to be randomized. Since a dropout rate of 20 % is conservatively estimated, a further 5 patients per intervention group should be randomized. Hence a total of 26 patients for each group will be recruited (overall 52 patients).

1. Biertho L, Thériault C, Bouvet L, Marceau S, Hould FS, Lebel S, Julien F, Tchernof A. Second-stage duodenal switch for sleeve gastrectomy failure: a matched controlled trial. Surgery for Obesity and Related Diseases. 2018 Oct 1;14(10):1570-9.l.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
31/08/2028
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 24474 0
New Zealand
State/province [1] 24474 0
Auckland

Funding & Sponsors
Funding source category [1] 308104 0
Hospital
Name [1] 308104 0
Waitemata DHB
Country [1] 308104 0
New Zealand
Primary sponsor type
Hospital
Name
Waitemata DHB
Address
124 Shakespeare Road, Takapuna, Auckland 0620
Country
New Zealand
Secondary sponsor category [1] 311649 0
None
Name [1] 311649 0
Address [1] 311649 0
Country [1] 311649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308090 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308090 0
Ethics committee country [1] 308090 0
New Zealand
Date submitted for ethics approval [1] 308090 0
17/07/2019
Approval date [1] 308090 0
05/11/2019
Ethics approval number [1] 308090 0
19/NTB/110

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

Contacts
Principal investigator
Name 109498 0
Mr Jason Robertson
Address 109498 0
Dept of General surgery
Level 8
North Shore Hospital
124 Shakespeare Road, Takapuna, Auckland 0620
Country 109498 0
New Zealand
Phone 109498 0
+64 9 486 8900
Fax 109498 0
Email 109498 0
jason.robertson@waitematadhb.govt.nz
Contact person for public queries
Name 109499 0
Jason Robertson
Address 109499 0
Dept of General surgery
Level 8
North Shore Hospital
124 Shakespeare Road, Takapuna, Auckland 0620
Country 109499 0
New Zealand
Phone 109499 0
+64 9 486 8900
Fax 109499 0
Email 109499 0
jason.robertson@waitematadhb.govt.nz
Contact person for scientific queries
Name 109500 0
Jason Robertson
Address 109500 0
Dept of General surgery
Level 8
North Shore Hospital
124 Shakespeare Road, Takapuna, Auckland 0620
Country 109500 0
New Zealand
Phone 109500 0
+64 9 486 8900
Fax 109500 0
Email 109500 0
jason.robertson@waitematadhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.