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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
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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
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Secondary ID [1]
303687
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Nil
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Universal Trial Number (UTN)
U1111-1226-6880
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obesity
321090
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Condition category
Condition code
Diet and Nutrition
318892
318892
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
322552
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [1]
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Hyperlipidaemia using fasting lipid blood test
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Assessment method [1]
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Timepoint [1]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [2]
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Patient satisfaction using validated quality of life outcome measures;
Bariatric Analysis and Reporting Outcome System (BAROS)
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Assessment method [2]
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Timepoint [2]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [3]
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Hypertension using blood pressure assessment at time of clinic follow-up
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Assessment method [3]
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Timepoint [3]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [4]
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Type 2 diabetes remission using HBA1c blood test
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Assessment method [4]
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Timepoint [4]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [5]
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Patient satisfaction using validated quality of life outcome measures using - Gastroesophageal reflux disease questionaire (GERDQ)
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Assessment method [5]
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Timepoint [5]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [6]
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Patient satisfaction using validated quality of life outcome measures using - Gastrointestinal Quality of Life Index (GIQLI)
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Assessment method [6]
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Timepoint [6]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [7]
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Patient satisfaction using validated quality of life outcome measures using - Short Form 36 (SF-36) questionnaire
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Assessment method [7]
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Timepoint [7]
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Baseline
Post operative at 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years
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Secondary outcome [8]
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Post-operative complications as a composite score graded according to Clavien-Dindo classification.
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Assessment method [8]
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Timepoint [8]
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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.
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central computerised randomisation
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2022
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Actual
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Date of last participant enrolment
Anticipated
31/07/2023
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Actual
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Date of last data collection
Anticipated
31/08/2028
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Actual
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Sample size
Target
52
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
24474
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Waitemata DHB
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Address [1]
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124 Shakespeare Road, Takapuna, Auckland 0620
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Country [1]
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New Zealand
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Primary sponsor type
Hospital
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Name
Waitemata DHB
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Address
124 Shakespeare Road, Takapuna, Auckland 0620
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
311649
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Address [1]
311649
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Country [1]
311649
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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17/07/2019
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Approval date [1]
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05/11/2019
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Ethics approval number [1]
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19/NTB/110
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Summary
Brief summary
The laparoscopic gastric sleeve (LSG) operation is an effective bariatric procedure, however, a significant number of patients experience weight regain or insufficient weight loss. In such cases, revisional bariatric operations can be performed in order to improve weight loss, comorbidity resolution and overall quality of life. Many different operations have been proposed for LSG conversion, and currently, the duodenal switch (DS) and the Roux-en-Y gastric bypass (RYGB) are the most popular options. Both operations are safely performed and lead to excellent weight loss and comorbidity resolution. Some studies report that a DS following LSG achieves a higher percentage excess weight loss (%EWL) than the RYGB, however other studies favour the RYGB as a revisional procedure as it
is a technically simpler operation and requires less vitamin supplementation to prevent nutritional deficiencies.
There a currently no prospective randomized controlled trials comparing these two operations to best inform patients undergoing LSG revision.
The primary objective of our study is to compare %EWL after conversion of a LSG to a RYGB, to conversion to a DS at 2 years of follow-up. We also aim to evaluate the resolution of comorbidities (particularly Type 2 Diabetes), post-operative complications and quality of life.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Jason Robertson
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Address
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Dept of General surgery
Level 8
North Shore Hospital
124 Shakespeare Road, Takapuna, Auckland 0620
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Country
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New Zealand
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Phone
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+64 9 486 8900
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Jason Robertson
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Address
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Dept of General surgery
Level 8
North Shore Hospital
124 Shakespeare Road, Takapuna, Auckland 0620
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Country
109499
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New Zealand
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Phone
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+64 9 486 8900
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Jason Robertson
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Address
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Dept of General surgery
Level 8
North Shore Hospital
124 Shakespeare Road, Takapuna, Auckland 0620
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Country
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New Zealand
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Phone
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+64 9 486 8900
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Fax
109500
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Email
109500
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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