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Trial registered on ANZCTR


Trial ID
ACTRN12613001047785
Ethics application status
Approved
Date submitted
14/09/2013
Date registered
19/09/2013
Date last updated
19/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Trial to determine which method of performing the Duodenal Switch leads to greater weight loss in morbidly obese patients.
Scientific title
Prospective randomised controlled trial comparing the effect of a standardised 100cm common channel and 150cm alimentary limb length versus an individually tailored small bowel partition on weight loss in the duodenal switch (DS) in morbidly obese patients.
Secondary ID [1] 283217 0
Nil
Universal Trial Number (UTN)
U1111-1148-0310
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 290085 0
Condition category
Condition code
Surgery 290462 290462 0 0
Surgical techniques
Diet and Nutrition 290480 290480 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compare 2 different ways of performing the Duodenal Switch. A standard 100cm common channel and 150 cm alimentary limb vs a tailored small bowel partition. To determine which technique provides superior weight loss and resolution of co-morbidities.

In order to tailor the small bowel the total small bowel length is measured intra-operatively. A common channel of 10% of the total small bowel length (but not less than 100cm) is fashioned. The alimentary limb is 40% of the total small bowel length. The small bowel anastamosis is performed in a side to side stapled fashion.

This is a descrition of the tailored small bowel partition. Approximate length of surgery 3-4 hours.
Intervention code [1] 287944 0
Treatment: Surgery
Comparator / control treatment
Total small bowel length is measured. A common channel of 100cm and an alimentary limb of 150 cm is made. The small bowel anastamosis is performed in a side to side stapled fashion.

This is a description of the standardised 100cm common channel and 150 cm alimentary limb.
Approxiamte length of surgery 3-4 hours
Control group
Active

Outcomes
Primary outcome [1] 290490 0
Weight loss. Weight and BMI measurements at every follow up appointment.
Timepoint [1] 290490 0
5 years
Secondary outcome [1] 304623 0
Resolution of diabetes
Clinical endpoints of diabetes control (fasting plasma glucose/HbA1c)
Timepoint [1] 304623 0
5 years
Secondary outcome [2] 304699 0
Quality of life changes measured by standardised quality of life questionnaires eg SF-36
Timepoint [2] 304699 0
5 years

Eligibility
Key inclusion criteria
Previous failed attempts at weight loss through diet and exercise.
BMI>/=40kg/m2 for at least 5 years.
Age between 20 and 55 years.
Suitable for either laparoscopic or open duodenal switch surgery.
Able to give informed consent and willing to commit to 5 year follow up.
Minimum age
20 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI> 70
Pregnancy
Prior bariatric surgery of any kind, oesophagogastric surgery, previous antrectomy or small bowel resection.
History of chronic pancreatitis or idiopathic acute pancreatitis.
Severe cardiorespiratory or gastrointestinal disease contraindicating anaesthesia.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomistaion by minimisation computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Appropriate statistical analysis will be performed at the end of the trial period.
Sample size has been calculated in consultation with a statistician (Dr Lifeng Zhou, WDHB). On the basis of an expected 20% difference in weight loss between the 2 groups at 2 years; using a 2 sided statistical test with a power of 80% and an a risk of 0.05, a sample size of 25 patents per group would be required assuming 100% follow up. Allowing for a 20% participant drop out rate, 30 participants per arm would be required

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 5412 0
New Zealand
State/province [1] 5412 0
Auckland

Funding & Sponsors
Funding source category [1] 287966 0
Hospital
Name [1] 287966 0
North Shore Hospital
Address [1] 287966 0
Shakespeare Road
Takapuna
Auckland 0622
Country [1] 287966 0
New Zealand
Primary sponsor type
Hospital
Name
Waitemata DHB
Address
North Shore HospitalShakespeare Road
Takapuna
Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 286684 0
None
Name [1] 286684 0
Address [1] 286684 0
Country [1] 286684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289889 0
Health and Disability equality Commission
Ethics committee address [1] 289889 0
Ethics committee country [1] 289889 0
New Zealand
Date submitted for ethics approval [1] 289889 0
14/10/2013
Approval date [1] 289889 0
Ethics approval number [1] 289889 0

Summary
Brief summary
To determine which method of performing the Duodenal Switch procedure leads to greater weight loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42954 0
Mr Hisham Hammodat
Address 42954 0
Dept of General Surgery
North Shore Hospital
Shakespeare Road
Takapuna
Auckland 0622
Country 42954 0
New Zealand
Phone 42954 0
+64 212740611
Fax 42954 0
Email 42954 0
hisham.hammodat@waitematadhb.govt.nz
Contact person for public queries
Name 42955 0
Mr Hisham Hammodat
Address 42955 0
Dept of General Surgery
North Shore Hospital
Shakespeare Road
Takapuna
Auckland 0622
Country 42955 0
New Zealand
Phone 42955 0
+64 212740611
Fax 42955 0
Email 42955 0
hisham.hammodat@waitematadhb.govt.nz
Contact person for scientific queries
Name 42956 0
Mr Hisham Hammodat
Address 42956 0
Dept of General Surgery
North Shore Hospital
Shakespeare Road
Takapuna
Auckland 0622
Country 42956 0
New Zealand
Phone 42956 0
+64 212740611
Fax 42956 0
Email 42956 0
hisham.hammodat@waitematadhb.govt.nz