Gastroesophageal Reflux DiseaseNCT01324791
Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)
A study testing anti-reflux surgery in people with Gastroesophageal Reflux Disease, run by General Public Hospital Zell am See at 1 site in Austria.
Trial summary
Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- anti-reflux surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- 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
- Adult, Older adult
Who may be able to join
- long history of GERD symptoms
- persistent or recurrent symptoms despite optimal medical treatment
- persistent or recurrent complications of GERD
- reduced quality of life owing to increasing esophageal exposure to gastric juice
- pathological values in the preoperative evaluated functional parameters.
Who cannot join
- any distinct hiatal hernia detectable by gastroscopy or barium radiography
- dysphagia
- esophageal strictures
- poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- anti-reflux surgery
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-reflux surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic antireflux surgery | Active comparator | Not described Receives: Procedure: anti-reflux surgery |
| endoscopic full-thickness-gastroplication | Active comparator | Not described Receives: Procedure: anti-reflux surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
Sponsor and investigators
- Lead sponsor
- General Public Hospital Zell am See
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324791
- Sponsor's protocol ID
- Zell02
- Status last verified
- Mar 2011
- First submitted
- 26 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT01324791
- Acronym / sponsor ID
- Zell02
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- General Public Hospital Zell am SeeUniversity, hospital or other
- First posted
- 29 Mar 2011 (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.
Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic antireflux surgery | Active comparator | Procedure: anti-reflux surgery |
| endoscopic full-thickness-gastroplication | Active comparator | Procedure: anti-reflux surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- long history of GERD symptoms
- persistent or recurrent symptoms despite optimal medical treatment
- persistent or recurrent complications of GERD
- reduced quality of life owing to increasing esophageal exposure to gastric juice
- pathological values in the preoperative evaluated functional parameters.
Key exclusion criteria (4 listed)
- any distinct hiatal hernia detectable by gastroscopy or barium radiography
- dysphagia
- esophageal strictures
- poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
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 |
|---|---|---|
| anti-reflux surgery | Procedure or surgery | endoscopic full-thickness-gastroplication, laparoscopic antireflux surgery |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-reflux surgery in people with Gastroesophageal Reflux Disease, run by General Public Hospital Zell am See at 1 site in Austria.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2011. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 29 Mar 2011.