Gastroesophageal RefluxVANTAGENCT02625077
Valvuloplasty as Alternative to Toupet Fundoplication for GERD
A study testing Laparoscopic gastroesophageal valvuloplasty and Laparoscopic Toupet fundoplication in people with Gastroesophageal Reflux and Hernia, Hiatal, run by Meander Medical Center at 1 site in Netherlands.
Trial summary
This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Hernia, Hiatal
- What is being tested?
- Laparoscopic gastroesophageal valvuloplasty and Laparoscopic Toupet fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objectively proven GERD (by gastroscopy and/or 24-hour pH and/or impedance monitoring)
- Age ≥18
- Written informed consent for study participation
Who cannot join
- BMI ≥ 30
- Hiatal hernia >3cm
- Achalasia
- Previous gastric surgery
- Previous esophageal surgery
- Inability to understand the Dutch language
- Inability to understand and/or fill in the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valvuloplasty as Alternative to Toupet Fundoplication for the Minimal Invasive Treatment of Gastroesophageal Reflux Disease: A Randomized Controlled Trial
This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be done in order to determine cost-effectiveness and costs per quality-adjusted life-year (QALY).
Read the detailed description
This is a prospective, interventional, double-blinded, monocenter randomized controlled trial comparing a laparoscopic gastroesophageal valvuloplasty to laparoscopic Toupet fundoplication in patients with proven GERD with a maximum hiatal hernia of 3cm. In this design, both patient and researcher are blinded to the treatment allocation.
Block randomization will be used to ensure an equal number in each treatment arm. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. To reduce selection bias by predictability of the treatment allocation, random block sizes are used. Also the investigator is kept blind to the size of each block. A computer is used to generate 15 blocks for each participating center with random block sizes of 4, 8 and 12. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence.
Patients will be included during a two-year period and followed for a minimum of one year. When a patient is referred to a participating surgeon for antireflux surgery, he or she will receive study information to give them sufficient time for consideration. The surgeon will ensure all required pre-operative diagnostic tests are performed and that the indication for surgery is valid. During a follow-up visit, the surgeon ascertains that the patient complies with all inclusion criteria and does not meet any of the exclusion criteria. Study participation will be discussed and after informed consent is obtained, the patient will be included in the trial.
After inclusion, the patient is immediately randomized but treatment allocation is not yet shared with the surgeon. The patient will receive validated questionnaires to record the pattern of symptoms, quality of life, medication and medical care usage. Data from the pre-operative tests will be recorded.
On the day of surgery, the surgeon will be able to see treatment allocation and after performing the appropriate surgical procedure, records the course and specifics of the surgical procedure. Patients will receive a diary to record their meals and symptoms.
Follow-up in the outpatient clinic will take place at the surgeon's discretion. At fixed moments: 3, 6 and 12 months after surgery, the patients will once more receive validated questionnaires. Also at about three months, a follow-up manometry and 24-hour pH and/or impedance monitoring will be performed.
A power analysis was performed to calculate the sample size. Our primary aim was to compare the effect of both surgical procedures. Based upon the current medical literature, the objective/subjective success rate for the laparoscopic Toupet fundoplication is around 88%. Pilot data from a retrospective cohort of patients that underwent valvuloplasty report a subjective success rate of 96%. Our hypothesis was that the gastroesophageal valvuloplasty is not inferior to the Toupet fundoplication when comparing its effects on acid control.
To prove non-inferiority of the valvuloplasty regarding acid reflux control, using a non-inferiority limit of 5%, 73 patients are required in each group. In all power calculations, a significance of 5% and power of 90% was used.
To accommodate for a loss to follow-up of up to 10 percent, a total sample size of 160 was chosen.
- Conditions
- Gastroesophageal Reflux, Hernia, Hiatal
- Being tested
- Laparoscopic gastroesophageal valvuloplasty, Laparoscopic Toupet fundoplication
- Keywords
- Valvuloplasty, Fundoplication, Acid reflux, GERD, Reflux disease, Hiatal hernia
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic gastroesophageal valvuloplastyProcedure or surgery
Laparoscopic Toupet fundoplicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic valvuloplasty | Experimental | Via laparoscopy, using three sutures a part of the esophagus is folded (similar to the way parts of a telescope slide in each other) into the stomach, creating a valve on the inside to prevent gastric acid to enter the esophagus. Receives: Procedure: Laparoscopic gastroesophageal valvuloplasty |
| Laparoscopic Toupet fundoplication | Active comparator | Via laparoscopy, the entire stomach is mobilized and folded around itself posteriorly, creating a partial (270 degrees) fundoplication. Receives: Procedure: Laparoscopic Toupet fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate, objective
Defined as % of patients with normal values of reflux measured by pH and impedance monitoring
Measured: 3 months post-operative
Secondary outcomes (7)
Success rate, subjective
Defined as % of patients with Visick score I or II
Measured: 3 months post-operative, 1 year post-operative
Percent of patients with complaints of functional dysphagia according to the Rome III criteria
% of patients with complaints of functional dysphagia according to the Rome III criteria.
Measured: 3 months post-operative, 1 year post-operative
Cost-effectiveness
Cost-effectiveness will be calculated by comparing the direct and indirect medical cost related to both strategies up until one years after the operation.
Measured: 1 year post-operative
Mortality rate
Defined as in-hospital mortality or out of hospital mortality within 30 days
Measured: 30 days
Complication rate
Intra-operative complication rate
Measured: During surgery
Conversion rate
Measured: During surgery
Disease related reoperation rate
% of patients requiring redo surgery for persisting complaints or recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Ethical concerns with efficacy of technique.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meander Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.C. Tolboom, MD, Meander Medical Center
- Investigators
- Werner A Draaisma, MD, PhD, Study director, Meander Medical CenterIvo AM Broeders, MD, PhD, Principal investigator, Meander Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625077
- Sponsor's protocol ID
- CHI-UPPERGI-VANTAGE
- Other IDs
- NL52398.100.15
- Acronym
- VANTAGE
- Status last verified
- Mar 2017
- First submitted
- 15 Nov 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valvuloplasty as Alternative to Toupet Fundoplication for the Minimal Invasive Treatment of Gastroesophageal Reflux Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02625077
- Acronym / sponsor ID
- VANTAGE / CHI-UPPERGI-VANTAGE
- Conditions
- Gastroesophageal Reflux, Hernia, Hiatal
- Keywords
- Valvuloplasty, Fundoplication, Acid reflux, GERD, Reflux disease, Hiatal hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethical concerns with efficacy of technique.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meander Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be done in order to determine cost-effectiveness and costs per quality-adjusted life-year (QALY).
Detailed description
This is a prospective, interventional, double-blinded, monocenter randomized controlled trial comparing a laparoscopic gastroesophageal valvuloplasty to laparoscopic Toupet fundoplication in patients with proven GERD with a maximum hiatal hernia of 3cm. In this design, both patient and researcher are blinded to the treatment allocation.
Block randomization will be used to ensure an equal number in each treatment arm. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. To reduce selection bias by predictability of the treatment allocation, random block sizes are used. Also the investigator is kept blind to the size of each block. A computer is used to generate 15 blocks for each participating center with random block sizes of 4, 8 and 12. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence.
Patients will be included during a two-year period and followed for a minimum of one year. When a patient is referred to a participating surgeon for antireflux surgery, he or she will receive study information to give them sufficient time for consideration. The surgeon will ensure all required pre-operative diagnostic tests are performed and that the indication for surgery is valid. During a follow-up visit, the surgeon ascertains that the patient complies with all inclusion criteria and does not meet any of the exclusion criteria. Study participation will be discussed and after informed consent is obtained, the patient will be included in the trial.
After inclusion, the patient is immediately randomized but treatment allocation is not yet shared with the surgeon. The patient will receive validated questionnaires to record the pattern of symptoms, quality of life, medication and medical care usage. Data from the pre-operative tests will be recorded.
On the day of surgery, the surgeon will be able to see treatment allocation and after performing the appropriate surgical procedure, records the course and specifics of the surgical procedure. Patients will receive a diary to record their meals and symptoms.
Follow-up in the outpatient clinic will take place at the surgeon's discretion. At fixed moments: 3, 6 and 12 months after surgery, the patients will once more receive validated questionnaires. Also at about three months, a follow-up manometry and 24-hour pH and/or impedance monitoring will be performed.
A power analysis was performed to calculate the sample size. Our primary aim was to compare the effect of both surgical procedures. Based upon the current medical literature, the objective/subjective success rate for the laparoscopic Toupet fundoplication is around 88%. Pilot data from a retrospective cohort of patients that underwent valvuloplasty report a subjective success rate of 96%. Our hypothesis was that the gastroesophageal valvuloplasty is not inferior to the Toupet fundoplication when comparing its effects on acid control.
To prove non-inferiority of the valvuloplasty regarding acid reflux control, using a non-inferiority limit of 5%, 73 patients are required in each group. In all power calculations, a significance of 5% and power of 90% was used.
To accommodate for a loss to follow-up of up to 10 percent, a total sample size of 160 was chosen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic valvuloplasty | Experimental | Procedure: Laparoscopic gastroesophageal valvuloplastyVia laparoscopy, using three sutures a part of the esophagus is folded (similar to the way parts of a telescope slide in each other) into the stomach, creating a valve on the inside to prevent gastric acid to enter the esophagus. |
| Laparoscopic Toupet fundoplication | Active comparator | Procedure: Laparoscopic Toupet fundoplicationVia laparoscopy, the entire stomach is mobilized and folded around itself posteriorly, creating a partial (270 degrees) fundoplication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Objectively proven GERD (by gastroscopy and/or 24-hour pH and/or impedance monitoring)
- Age ≥18
- Written informed consent for study participation
Key exclusion criteria (7 listed)
- BMI ≥ 30
- Hiatal hernia >3cm
- Achalasia
- Previous gastric surgery
- Previous esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic gastroesophageal valvuloplasty | Procedure or surgery | Laparoscopic valvuloplasty |
| Laparoscopic Toupet fundoplication | Procedure or surgery | Laparoscopic Toupet fundoplication |
Primary outcome
Success rate, objective
Time frame: 3 months post-operative
Defined as % of patients with normal values of reflux measured by pH and impedance monitoring
7 secondary outcomes
Success rate, subjective
Time frame: 3 months post-operative, 1 year post-operative
Percent of patients with complaints of functional dysphagia according to the Rome III criteria
Time frame: 3 months post-operative, 1 year post-operative
Cost-effectiveness
Time frame: 1 year post-operative
Mortality rate
Time frame: 30 days
Complication rate
Time frame: During surgery
Conversion rate
Time frame: During surgery
Disease related reoperation rate
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Meander Medical CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner A Draaisma, MD, PhD study director
Meander Medical Center
Ivo AM Broeders, MD, PhD principal investigator
Meander Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic gastroesophageal valvuloplasty and Laparoscopic Toupet fundoplication in people with Gastroesophageal Reflux and Hernia, Hiatal, run by Meander Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate, objective (time frame: 3 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.