Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000234516
Ethics application status
Approved
Date submitted
6/01/2015
Date registered
13/03/2015
Date last updated
13/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
High Resolution Impedance Manometry (HRIM) and Impedance pH (ZpH) Testing to evaluate reflux and oesophageal motility following laparoscopic sleeve gastrectomy in morbidly obese patients
Scientific title
High Resolution Impedance Manometry (HRIM) and Impedance pH (ZpH) Testing to evaluate reflux and oesophageal motility following laparoscopic sleeve gastrectomy in morbidly obese patients
Secondary ID [1] 285920 0
nil
Universal Trial Number (UTN)
Trial acronym
HRIM and ZpH following Laparoscopic Sleeve Gastrectomy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293840 0
reflux 293841 0
sleeve gastrectomy 293842 0
Condition category
Condition code
Surgery 294144 294144 0 0
Other surgery
Diet and Nutrition 294145 294145 0 0
Obesity
Oral and Gastrointestinal 294522 294522 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To study reflux in patients with morbid obesity prior to and after sleeve gastrectomy. Manometry and oesophageal acid studies are catheter based investigations performed on an outpatient basis without requirement for anaesthesia. Manometry takes 10 minutes to perform, whereas pH (Acid) studies require the subject to have a fine catheter in their oesophagus (placed via the nose) for 24 hours. These studies will be performed pre-operatively and six months following Sleeve Gastrectomy surgery. A short reflux symptom questionnaire will also be filled in.
Intervention code [1] 290896 0
Not applicable
Comparator / control treatment
pre vs post-op study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293940 0
Oesophageal motility as determined by Manometry
Timepoint [1] 293940 0
6 months following sleeve gastrectomy
Primary outcome [2] 294383 0
reflux as determined by pH studies and Gastro-oesophageal Disease Reflux Assessment Score (GSAS)
Timepoint [2] 294383 0
6 months after sleeve gastrectomy
Secondary outcome [1] 312200 0
Weight loss a percentage of initial weight.
Timepoint [1] 312200 0
six months following sleeve gastrectomy surgery.

Eligibility
Key inclusion criteria
morbid obesity
consented for sleeve gastrectomy
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous bariatric surgery.
contra-indications to sleeve gastrectomy
severe pre-op reflux

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Comparison of pre-vs post reflux according to standardised methodologies. Participant number was based on previous observational studies of reflux. Prior publications indicate that a minimum number or 15 patients seems to be required to determine the presence of abnormal reflux in a defined population, but also that there is a drop-out rate of 1/3-1/2 between initial an subsequent testing.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/01/2014
Actual
6/01/2014
Date of last participant enrolment
Anticipated
1/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3304 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 9085 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 290499 0
Commercial sector/Industry
Name [1] 290499 0
Johnson and Johnson
Country [1] 290499 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Talbot
Address
Suite 3, Level 5
St George Private Hospital
1 South St
Kogarah
NSW2217
Country
Australia
Secondary sponsor category [1] 289198 0
None
Name [1] 289198 0
Address [1] 289198 0
Country [1] 289198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292156 0
UNSW
Ethics committee address [1] 292156 0
UNSW Australia
High St
Kensington, NSW 2052
Australia
Ethics committee country [1] 292156 0
Australia
Date submitted for ethics approval [1] 292156 0
01/02/2013
Approval date [1] 292156 0
22/10/2013
Ethics approval number [1] 292156 0
HREC Ref: # HC13088

Summary
Brief summary
It is known that some patients can develop significant reflux following sleeve gastrectomy for morbid obesity, but due to a lack of prospective evaluation the factors underlying the risk for reflux are unknown.
In this study, patients before undergoing sleeve gastrectomy will undertake a validated reflux score, have and endoscopy and High Resolution Impedance Manometry and 24 hour Impedance pH testing.
6 months post operatively they will repeat the reflux questionnaire, the manometry and pH testing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53818 0
Dr Michael Talbot
Address 53818 0
Suite 3, Level 5
St George Private Hospital
1 South St
Kogarah
NSW 2217
Country 53818 0
Australia
Phone 53818 0
+61295531120
Fax 53818 0
Email 53818 0
m.talbot@unsw.edu.au
Contact person for public queries
Name 53819 0
Mrs Tania Matisan
Address 53819 0
Suite 3, Level 5
St George Private Hospital
1 South St
Kogarah
NSW 2217
Country 53819 0
Australia
Phone 53819 0
+61295531120
Fax 53819 0
Email 53819 0
TaniaM@uppergisurgery.com.au
Contact person for scientific queries
Name 53820 0
Mrs Tania Matisan
Address 53820 0
Suite 3, Level 5
St George Private Hospital
1 South St
Kogarah
NSW 2217
Country 53820 0
Australia
Phone 53820 0
+61295531120
Fax 53820 0
Email 53820 0
TaniaM@uppergisurgery.com.au

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

Documents added manually
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Documents added automatically
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