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Trial registered on ANZCTR


Registration number
ACTRN12622000636752p
Ethics application status
Submitted, not yet approved
Date submitted
8/02/2022
Date registered
2/05/2022
Date last updated
2/05/2022
Date data sharing statement initially provided
2/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of two different operations to treat gastro-oesophageal reflux disease in obese patients
Scientific title
Efficacy of laparoscopic fundoplication versus laparoscopic Roux-en-Y gastric bypass for treatment of gastro-oesophageal reflux disease in obese patients; a randomised, controlled trial
Secondary ID [1] 306372 0
None
Universal Trial Number (UTN)
U1111-1274-0877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-oesophageal reflux disease 325186 0
obesity 325187 0
Condition category
Condition code
Oral and Gastrointestinal 322584 322584 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 322585 322585 0 0
Obesity
Surgery 322586 322586 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic Roux-en-Y gastric bypass

The operation will be performed by or under the direct supervision of a consultant upper gastrointestinal surgeon. The patient will be supine or placed in lithotomy position. Four laparoscopic ports and an epigastric retractor will be placed. A dissection of the oesophageal hiatus will be performed, preserving both vagus nerves, and a cruroplasty will be performed as required using non-absorbable sutures. Crural dissection, cruroplasty and fixation of the distal oesophagus and gastric pouch will be performed as required. Dissection at the mid-lesser curve and at the cardia will allow an assessment of the lesser sac, with successive stapler firings to create a small gastric pouch. The gastric pouch will be calibrated using a 34Fr bougie and a target length of 7cm. The gastrocolic omentum may be split vertically at the surgeon’s discretion to allow safe delivery of the small bowel. The jejunum will be divided to give a biliopancreatic limb length of approximately 70cm. The alimentary limb will be measured to a length of 70-120cm (tailored by the surgeon to the patient’s BMI). The anastomotic technique used will be at the operating surgeon’s discretion but will be recorded for possible future analyses. The mesenteric defect and Peterson’s space will be closed with non-absorbable suture. The operation will take approximately 2 hours.
Intervention code [1] 322800 0
Treatment: Surgery
Comparator / control treatment
Laparoscopic fundoplication

The operation will be performed by or under the direct supervision of a consultant upper gastrointestinal surgeon. The patient will be supine or placed in lithotomy position. Four laparoscopic ports and an epigastric retractor will be placed. A dissection of the oesophageal hiatus will be performed, preserving both vagus nerves, and a cruroplasty will be performed as required using non-absorbable sutures. Sufficient fundal mobility will be achieved to allow a partial fundoplication (anterior or posterior) and fixation of the fundus to the diaphragmatic crura and oesophagus will be achieved with non-absorbable sutures. The wrap type as well as division of the short gastric vessels and use of a calibrating device will be at the discretion of the operating surgeon. Operative time is approximately 1.5 hours. An audit of operation reports will be completed to identify technical details such as the presence of a hiatus hernia and the type and degree of wrap performed
Control group
Active

Outcomes
Primary outcome [1] 330381 0
Gastroesophageal reflux symptom severity assessed using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) scale
Timepoint [1] 330381 0
Baseline and 1 year post-surgery
Secondary outcome [1] 406029 0
Gastroesophageal reflux symptom severity assessed using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) scale
Timepoint [1] 406029 0
Baseline and 5 years post-surgery
Secondary outcome [2] 406030 0
Objective evidence of efficacy using a composite score of
1. percentage of time spent with pH<4 in the oesophagus (24 hour trans-nasal catheter) and
2. presence and severity of oesophagitis on endoscopy (Los Angeles Classification of Reflux Oesophagitis)
Timepoint [2] 406030 0
Baseline, 1 and 5 years post-surgery

Oesophageal pH will be assessed at each timepoint by being monitored continuously over a 24-hour period
Secondary outcome [3] 406031 0
Gastro-intestinal quality of life assessed using the Structured Assessment of Gastrointestinal Symptoms (SAGIS) scale
Timepoint [3] 406031 0
Baseline, 1 and 5 years post-surgery
Secondary outcome [4] 408754 0
Overall quality of life assessed using the SF-6Dv2 questionnaire
Timepoint [4] 408754 0
Baseline, 1 and 5 years post-surgery
Secondary outcome [5] 408755 0
Weight assessed using electronic standing scales
Timepoint [5] 408755 0
Baseline, 1 and 5 years post-surgery

Eligibility
Key inclusion criteria
Aged greater than or equal to 18 years and less than or equal to 70 years
All genders
Troublesome symptoms despite maximal medical therapy with 24h pH monitoring (+/- impedence study if locally available) supportive of the diagnosis
BMI 30-34.9 with waist circumference >88cm (women) or >102cm (men)
BMI 35-40 with any waist-circumference
Able and willing to give written consent
Willing to perform the questionnaires, investigations and post-operative follow-up required for this study
Able to access regular medical care (in the event of post-operative complication such as internal hernia, and for nutritional screening and supplementation measures)
Suitable for either surgery
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intra-thoracic stomach (hiatus hernia with >50% of stomach in thorax)
Previous gastro-oesophageal surgery (bariatric, anti-reflux, ulcer, motility disorder)
Multiple surgeries in abdominal cavity or previous small bowel pathology or resection
Clinical or manometry findings concerning for a severe oesophageal dysmotility syndrome (recognising that clinically silent manometry-defined motility disorders are common in obesity)
Any medical condition deemed by an investigator to render the patient ineligible (e.g. conditions that may be exacerbated by gastric bypass surgery such as osteoporosis)
Inflammatory bowel disease
Pregnant or lactating female (routine pre-operative pregnancy test for all female patients with child-bearing potential)
Endocrine cause of obesity
Current smoker
Drug or alcohol abuse
Psychological disorders (e.g. bulimia, depression)

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)
Yes (centralised computer randomisation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with stratification for gender, BMI and percentage of time with oesophageal pH<4 (severity of reflux)
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
Using alpha = 0.05, beta = 0.8, a randomisation ratio of 1:1 and a mean GERD-HRQL score of 8 (standard deviation 8) after laparoscopic fundoplication (LF) in class I and II obesity and 5 after laparoscopic Roux-en-Y gastric bypass (LRYGB), a sample size of 164 would be required. Assuming a 10% drop-out, there would need to be 91 patients in each arm.

Acknowledging the lack of data to guide power calculations and hence the possibility that the alternative treatment (LRYGB) may give the same mean GERD-HRQL score as the control treatment (LF), a planned non-inferiority analysis will also be performed. Using alpha = 0.05, beta = 0.9, a randomisation ratio of 1:1, a mean GERD-HRQL score of 8 (standard deviation 8) after LF in class I and II obesity and a non-inferiority limit (d) of 4, a sample size of 138 is required. Assuming a 10% drop-out, there would need to be 77 patients in each arm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
31/05/2030
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21665 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 21666 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 21667 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [4] 21668 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 36711 0
4029 - Herston
Recruitment postcode(s) [2] 36710 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 36712 0
4108 - Coopers Plains
Recruitment postcode(s) [4] 36713 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 310724 0
Other
Name [1] 310724 0
Royal Australasian College of Surgeons
Country [1] 310724 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd
Woolloongabba, Qld 4102
Country
Australia
Secondary sponsor category [1] 311948 0
None
Name [1] 311948 0
Address [1] 311948 0
Country [1] 311948 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310301 0
Metro South Health
Ethics committee address [1] 310301 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 310301 0
Australia
Date submitted for ethics approval [1] 310301 0
06/02/2022
Approval date [1] 310301 0
Ethics approval number [1] 310301 0

Summary
Brief summary
Laparoscopic Fundoplication (LF) is the gold standard surgical procedure for the treatment of Gastro-Oesophageal Reflux Disease (GORD). Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is commonly performed to achieve weight loss in obese patients, but it also has anti-reflux properties. Hence, in the obese population suffering from GORD, LRYGB is an attractive alternative to LF and indeed is recommended in some national and international guidelines despite there being no randomised trials comparing the two procedures to provide efficacy data (subjective or objective), either in normal, overweight or obese patients. The aim of this trial is to compare LF and LRYGB in an obese population presenting for consideration of surgical correction of GORD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117178 0
Dr Adam Frankel
Address 117178 0
Level 4, Building 1
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Qld 4102
Country 117178 0
Australia
Phone 117178 0
+61 7 3176 2633
Fax 117178 0
Email 117178 0
a.frankel@uq.edu.au
Contact person for public queries
Name 117179 0
Dr Adam Frankel
Address 117179 0
Level 4, Building 1
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Qld 4102
Country 117179 0
Australia
Phone 117179 0
+61 7 3176 2111
Fax 117179 0
Email 117179 0
a.frankel@uq.edu.au
Contact person for scientific queries
Name 117180 0
Dr Adam Frankel
Address 117180 0
Level 4, Building 1
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Qld 4102
Country 117180 0
Australia
Phone 117180 0
+61 7 3176 2111
Fax 117180 0
Email 117180 0
a.frankel@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14976Study protocol    Will be published in the coming months
14977Informed consent form    pending ethics approval
14978Ethical approval    pending
14979Statistical analysis plan    Will be published within the trial protocol in the... [More Details]


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14976Study protocolLaparoscopic fundoplication versus laparoscopic Roux-en-Y gastric bypass for gastro-oesophageal reflux disease in obese patients; protocol for a randomised, controlled trial. Frankel A, Thomson I, Shah A, Chen C, Zahir F, Barbour A, Holtmann G, Smithers BM. BJS Open, Volume 6, Issue 6, December 2022. https://doi.org/10.1093/bjsopen/zrac132   
14977Informed consent form    Ethics approval achieved 383530-(Uploaded-14-04-2023-12-39-54)-Study-related document.docx
14978Ethical approval    Approved 383530-(Uploaded-14-04-2023-12-39-54)-Study-related document.pdf
14979Statistical analysis plan    see BJS Open

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLaparoscopic fundoplication versus laparoscopic Roux-en-Y gastric bypass for gastro-oesophageal reflux disease in obese patients: protocol for a randomized clinical trial.2022https://dx.doi.org/10.1093/bjsopen/zrac132
N.B. These documents automatically identified may not have been verified by the study sponsor.