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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623000501640
Ethics application status
Approved
Date submitted
1/04/2023
Date registered
16/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
16/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Endoscopic versus Surgical Treatment of Reflux
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Scientific title
Quality of Life Following Endoscopic Anti-Reflux Mucosal Ablation versus Nissen Fundoplication for Refractory Reflux: a blinded randomised control trial
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Secondary ID [1]
309346
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None
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Universal Trial Number (UTN)
U1111-1290-5421
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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:
Reflux
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Condition category
Condition code
Surgery
326484
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0
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Surgical techniques
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Oral and Gastrointestinal
326749
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ARMA: (Anti-reflux mucosal ablation).
This will usually be performed under local sedation (where you will still be breathing on your own). Here the junction is lasered, which as it heals and scars, tightens the junction. This is called anti-reflux mucosal ablation (AMRA).
i.e. Ablation of gastro-oesophageal junction with argon plasma coagulation to create ulceration, fibrosis and subsequent constriction and tightening of the junction to prevent reflux.
Performed by Gastroenterologist. Procedure recorded on clinical record. Estimated time: 30 minutes.
Equipment:
APC (Argon plasma coagulation) generator & straight fire probe
EMR (endoscopic mucosal resection) solution – saline with 0.5% methylene blue
Clear endoscope cap
Specify endoscope with adequate flex (ie older scope)
IV (intravenous) omeprazole and antiemetic as part of sedation
ERBE Vio-200D Effect 3 100W (Mexican), VIO300D Effect 2 50W (Japanese)
Procedure
• Evaluate & clean GOJ (Gastro-oesophageal junction) & Hill Grade
• Mark borders of ablation; Effect 2 soft coagulation
o Markers around inner border 1cm from GOJ,
o Markers either side of 1cm greater curve untouched segment (<90o)
o Markers on outer border 1-2cm width, horse-shoe shape
• Lift cushion with EMR solution
• Sequential Ablation with ERBE
• Scrape/Clear tissue with cap
• Complete ablation if necessary
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Intervention code [1]
325784
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Treatment: Surgery
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Comparator / control treatment
Laparoscopic Nissen Fundoplication
This is a keyhole (laparoscopic) operation under general anaesthetic (where you are completely asleep and unaware, with a machine breathing for you). This involves using tiny incisions (cuts) in the abdomen to view inside the body and perform the procedure, whereby the top of the stomach is gently wrapped around the lower oesophagus (gullet) to tighten the junction, which is currently too loose. This will help to prevent the acid to splash back which causes the reflux symptoms. This operation is called a Nissen Fundoplication.
Duration: 1-1.5 hours
Performed by General Surgical Consultants
Procedure will be recorded in clinical notes with a standard operation note.
Procedure
General anaesthetic
Antibiotic prophylaxis at induction
Patient placed in supine position
Optical entry in left upper quadrant of abdomen
Humidified CO2 insufflation to achieve pneumoperitoneum at pressure of 12mmHg
Including the optical entry port a total of 4 x laparoscopic working ports inserted across upper abdomen (2x5mm and 2x12mm) and laparoscopic liver retractor placed in epigastrium
Circumferential hiatal dissection performed using energy device to ensure >/=3cm intra-abdominal oesophageal length
Clear identification and preservation of anterior and posterior vagal nerves
Posterior +/- anterior crural closure calibrated loosely over 40f Bougie with non-absorbable 0 V-Loc™ (Covidien, Dublin, Ireland)
Mobilisation of fundus via proximal division of short gastric vessels for creation of a short (2-3cm) floppy 360 degree fundoplication. Wrap secured with 2.0 Ti-Cron sutures (Covidien, Mansfield, Mass).
Local anaesthetic applied intraperitoneal and to laparoscopic port sites
Pneumoperitoneum deflated
Monocryl subcuticular sutures to skin
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Control group
Active
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Outcomes
Primary outcome [1]
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The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
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Assessment method [1]
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Timepoint [1]
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6 months post procedure
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Primary outcome [2]
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24hr pH exposure (as assessed at pH testing) within normal range
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Assessment method [2]
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Timepoint [2]
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Baseline (pre-procedure), then 6 months post-procedure.
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Secondary outcome [1]
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GERD-HRQL quality of life outcome
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Assessment method [1]
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Timepoint [1]
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Yearly for 3 years post procedure
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Secondary outcome [2]
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SHORTFORM -36: Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36)
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Assessment method [2]
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Timepoint [2]
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6 months, then yearly for 3 years post procedure
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Secondary outcome [3]
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QOL (quality of life) questionnaire for patients undergoing anti-reflux surgery (QOLARS)
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Assessment method [3]
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Timepoint [3]
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6 months then yearly for 3 years post procedure
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Secondary outcome [4]
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Operation time as noted from surgical records
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Assessment method [4]
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Timepoint [4]
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Post-procedure
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Secondary outcome [5]
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Blood loss as noted from surgical records
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Assessment method [5]
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Timepoint [5]
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Post procedure
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Secondary outcome [6]
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Hospital length of stay from medical records
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Assessment method [6]
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Timepoint [6]
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At time of discharge
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Secondary outcome [7]
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Pain as deduced from medical records
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Assessment method [7]
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Timepoint [7]
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At time of discharge
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Secondary outcome [8]
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Narcotic discontinuation / return to ADL (activities of daily living) - as advised by patient documented in medical record
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Assessment method [8]
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Timepoint [8]
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Post-procedure and discharge from hospital
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Secondary outcome [9]
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Complications: readmission, bleeding, or pain as noted from medical record
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Assessment method [9]
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Timepoint [9]
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30 days post procedure
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Secondary outcome [10]
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Mortality (death)
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Assessment method [10]
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Timepoint [10]
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30 days post procedure
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Secondary outcome [11]
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Need for further procedure (either dilation or fundoplication) - as noted from medical record
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Assessment method [11]
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Timepoint [11]
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6-12 months post procedure
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Secondary outcome [12]
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Complications:
Dysphagia
Gas-Bloating
Diarrhoea
As directly asked to patient in follow-up clinic (noted on medical record)
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Assessment method [12]
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Timepoint [12]
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Within 6 months post procedure
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Eligibility
Key inclusion criteria
Symptomatic gastro-oesophageal reflux, despite 2 months twice daily of PPI (proton pump inhibitor) use, and attempts to optimise lifestyle measures contributing to reflux events.
Confirmation of pathological reflux via 24-hr Oesophageal pH testing; either
• Acid Exposure Time >6%
• DeMeester Score >14.7
• Positive SAP (symptom association probability) (95%) with SI (Symptom index) >70%
Or:
• Los Angeles (LA) Grade C-D oesophagitis
High resolution oesophageal manometry performed in all patients to confirm the absence of major oesophageal motility disorders.
Consenting to participate in trial: willing to undergo either ARMA or surgical fundoplication
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Minimum age
18
Years
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Maximum age
No limit
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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
Hiatus Hernia; Hill Grade IV or sliding hiatus hernia >2cm
Contra-indications to surgical fundoplication
- Previous major abdominal surgery precluding laparoscopy
- Previous gastric surgery
Major motility disorder on HR (high resolution) manometry assessment (as defined by Kahrilas et al)
- Minor motility disorder with functional impact (abnormal Ba swallow or solid food challenge)
Pregnancy
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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
Patients will be randomised following consent to enter the trial. They will not be made aware of their allocation status until the day of their procedure.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based randomisation 1:1
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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
Safety/efficacy
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Statistical methods / analysis
Power calculations:
Power calculations were conducted using PASS version 11 (NCSS Statistical Software LLC, Utah, USA), with the change in GERD-HRQL score at 6 months being the pre-specified primary outcome for determining sample size. Sample size requirements were based on intention to treat (ITT) analysis of detecting non-inferiority of ARMA to fundoplication, with an a priori non-inferiority margin of delta </= 5 points for change in GERD-HRQL score. The results show that a minimum of 50 participants (25 participants per treatment group) was required to detect non-inferiority, with 80% power (ß = 0.2), at a one-sided statistical significance level of 5% (a =0.05). The SD of GERD-HRQL scores was estimated to be 7 points, based on a recent retrospective review of 100 patients.
Statistical analysis plan:
Statistical analysis will be performed using SAS version 9.4 (SAS Institute Inc, North Carolina, USA). The primary analysis will be conducted using an intention to treat (ITT) approach with baseline observation carried forward. The primary non-inferiority outcomes (improvements in GERD-HRQL score and pH measurements) will be analysed using the non-inferiority margin-adjusted one-tailed independent samples t-test. Secondary superiority outcomes will be assessed using the two-tailed independent t-test for continuous measurement with normal distributions confirmed by Shapiro-Wilk testing (p>0.05). Non-normally distributed continuous and ordinal data will be analysed using the two-tailed Mann-Whitney U-test, and categorical data using the two-tailed Fisher’s exact test. Data will be presented as mean +/-SD, median (IQR), number of participants (% of participants), unless otherwise stated, and p<0.05 will be considered significant.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
5/06/2023
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Actual
12/01/2024
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Date of last participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last data collection
Anticipated
3/04/2028
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Actual
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Sample size
Target
50
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Accrual to date
3
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
25370
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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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Te Whatu Ora - Waitemata (North Shore Hospital)
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Address [1]
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24 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
Te Whatu Ora - Waitemata (North Shore Hospital)
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Address
24 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]
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Address [1]
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Country [1]
315347
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern 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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23/02/2023
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Approval date [1]
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28/04/2023
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Ethics approval number [1]
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2023 FULL 15109
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Summary
Brief summary
Gastro-oesophageal reflux disease (GORD) is common, affecting up to 30% of the population, with an increasing prevalence including younger patients.Symptoms have been shown to have significant impact on quality of life and productivity with considerable economic burden.
Although medical treatment such as proton pump inhibitors (PPI) may be successful in treating up to 80% of patients with erosive disease, compliance, side-effects and patient preference may limit efficacy. In addition, non-erosive disease and regurgitation is less successfully treated with PPI. In these patients, anti-reflux surgery with fundoplication has been the traditional treatment, shown to be more effective than medical management with respect to patient-relevant outcomes, although some uncertainty remains with respect to longer term outcomes.
More recently, simple endoscopic techniques have been developed as an alternative to tighten the lower oesophageal junction. Ablation with argon plasma coagulation (ARMA) to create ulceration, fibrosis and subsequent constriction have been described. A recent meta-analysis of 15 studies using these techniques demonstrate them to be safe and efficacious for PPI refractory reflux.
Few studies exist comparing endoscopic to surgical techniques. A retrospective review comparing endoscopic to laparoscopic Nissen fundoplication suggested better perioperative outcomes with regard to operation time, blood loss, hospital stay and pain, with comparable reflux quality of life outcomes to 2 years. No prospective randomised trials exist.
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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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Dr Cameron Schauer
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Address
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C/O Gastroenterology Department
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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+64210368637
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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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Dr Cameron Schauer
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Address
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C/O Gastroenterology Department
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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+64210368637
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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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Dr Cameron Schauer
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Address
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C/O Gastroenterology Department
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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+64210368637
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Fax
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Email
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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
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18771
Study protocol
385660-(Uploaded-01-04-2023-13-17-22)-Study-related document.docx
18773
Informed consent form
385660-(Uploaded-30-04-2023-14-10-35)-Study-related document.docx
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.
Download to PDF