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Trial registered on ANZCTR


Registration number
ACTRN12609000030279
Ethics application status
Approved
Date submitted
18/12/2008
Date registered
16/01/2009
Date last updated
16/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term Outcome of Laparoscopic Nissen and Laparoscopic Toupet Fundoplication for Gastro-Esophageal Reflux Disease: a prospective, randomized trial.
Scientific title
Long-term Outcome of Laparoscopic Nissen and Laparoscopic Toupet Fundoplication for Gastro-Esophageal Reflux Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-esophageal reflux disease 4145 0
Condition category
Condition code
Oral and Gastrointestinal 4348 4348 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 4416 4416 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Laparoscopic Nissen fundoplication involves repair of the crural defect in the diaphragm, together with a 360 degree wrap of the fundus of the stomach around the lower end of the intra-abdominal oesophagus. This is performed laparoscopically and is a single intervention
Intervention code [1] 3860 0
Treatment: Surgery
Comparator / control treatment
Laparoscopic Toupet fundoplication involves repair of the crural defect in the diaphragm and fashioning a 270 degree posterior wrap of the oesophagus with the fundus of the stomach. This is a single intervention
Control group
Active

Outcomes
Primary outcome [1] 5303 0
Long term outcome was measured by means of patient staistfaction scores of the following questions: would you have repeat surgery if you had to choose again/ would you recommend surgery to others/are you better off than before surgery
Timepoint [1] 5303 0
For this particular study, these questions were asked to the entire study population at a fixed time point (2005), 4 years after the last patient was enrolled, as the focus of this study was long-term follow-up
Secondary outcome [1] 8923 0
None
Timepoint [1] 8923 0
None

Eligibility
Key inclusion criteria
Inclusion criteria

1. PPI(proton pump inhibitor) dependent, erosive reflux, OR
2. Volume reflux not responsive to PPI, AND
3. Willingness to undergo long-term follow-up AND
4. Willingness to sign informed consent
5. Abnormal motility included provided an absence of apersitalsis (achalasia)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Esophageal stricture, or
2. Extra-esophageal symptoms unresponsive to PPI, or
3. Previous abdominal or gastric surgery, or
4. Surgically unfit patients, or
5. Refusal to undergo long-term follow-up, or
6. Refusal or inability to sign informed consent, or
7. Age less than 18 years

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)
A computer-generated randomization chart for 100 patients was printed and kept in sealed opaque envelopes by the department secretary who did not otherwise particpate in the study. The randomization took place by means of a telephone call from theatre once it was determined that a laparoscopic anti-reflux operation was feasible. Patients and those collecting follow-up data were blinded as to the procedure performed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization chart
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 1479 0
South Africa
State/province [1] 1479 0
Western Cape

Funding & Sponsors
Funding source category [1] 4316 0
Hospital
Name [1] 4316 0
Groote Schuur Hospital
Address [1] 4316 0
Anzio Road
Observatory
Cape Town
Country [1] 4316 0
South Africa
Primary sponsor type
Hospital
Name
Groote Schuur Hospital
Address
Anzio Road
Observatory
Cape Town
Country
South Africa
Secondary sponsor category [1] 3887 0
None
Name [1] 3887 0
Address [1] 3887 0
Country [1] 3887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6364 0
Research Ethics Committee, University of Cape Town
Ethics committee address [1] 6364 0
Research Ethics Committee
Old Main Building
Anzio Road
Observatory
Cape Town
Ethics committee country [1] 6364 0
South Africa
Date submitted for ethics approval [1] 6364 0
01/02/1997
Approval date [1] 6364 0
01/04/1997
Ethics approval number [1] 6364 0
093/97

Summary
Brief summary
The primary purpose of the study is to compare two commonly performed anti-reflux surgical procedures and to assess whether there is any difference in long-term patient satisfaction between these two procedures
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35051 0
Address 35051 0
Country 35051 0
Phone 35051 0
Fax 35051 0
Email 35051 0
Contact person for public queries
Name 12398 0
John Shaw
Address 12398 0
E 23,GIT Clinic
Groote Schuur Hospital
Anzio Road
Observatory 7975
Country 12398 0
South Africa
Phone 12398 0
+27-21-404-3042
Fax 12398 0
+27-21-447-8240
Email 12398 0
John.Shaw@uct.ac.za
Contact person for scientific queries
Name 3326 0
John Shaw
Address 3326 0
E 23,GIT Clinic
Groote Schuur Hospital
Anzio Road
Observatory 7975
Country 3326 0
South Africa
Phone 3326 0
+27-21-404-3042
Fax 3326 0
+27-447-8240
Email 3326 0
John.Shaw@uct.ac.za

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary