Gastroesophageal Reflux DiseaseNCT01321294
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
A study testing laparoscopic anti-reflux surgery in people with Gastroesophageal Reflux Disease and Laparoscopic Antireflux Surgery, run by General Public Hospital Zell am See at 1 site in Austria.
Trial summary
The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Laparoscopic Antireflux Surgery
- What is being tested?
- laparoscopic 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
- Clinical diagnosis of gastroesophageal reflux disease
- 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
- Previous esophageal or gastric surgery
- Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
General Public Hospital Zell am See
Zell am See, State of Salzburg, 5700
About this study
The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.
- Being tested
- laparoscopic 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.
laparoscopic anti-reflux surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nissen fundoplication | Active comparator | Not described Receives: Procedure: laparoscopic anti-reflux surgery |
| Toupet fundoplication | Active comparator | Not described Receives: Procedure: laparoscopic 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 posted23 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT01321294
- Sponsor's protocol ID
- Zell01
- Status last verified
- Mar 2011
- First submitted
- 21 Mar 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
Publications
Koch OO, Kaindlstorfer A, Antoniou SA, Luketina RR, Emmanuel K, Pointner R. Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications. Surg Endosc. 2013 Jul;27(7):2383-90. doi: 10.1007/s00464-013-2803-0. Epub 2013 Jan 30.
PubMed 23361260
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01321294
- Acronym / sponsor ID
- Zell01
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- General Public Hospital Zell am SeeUniversity, hospital or other
- First posted
- 23 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.
The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nissen fundoplication | Active comparator | Procedure: laparoscopic anti-reflux surgery |
| Toupet fundoplication | Active comparator | Procedure: laparoscopic anti-reflux surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of gastroesophageal reflux disease
- 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
Key exclusion criteria (3 listed)
- Previous esophageal or gastric surgery
- Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)
- 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 |
|---|---|---|
| laparoscopic anti-reflux surgery | Procedure or surgery | Nissen fundoplication, Toupet fundoplication |
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 23 Mar 2011.
- Derived from this study: PubMed 23361260Koch OO, Kaindlstorfer A, Antoniou SA, Luketina RR, Emmanuel K, Pointner R. Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications. Surg Endosc. 2013 Jul;27(7):2383-90. doi: 10.1007/s00464-013-2803-0. Epub 2013 Jan 30.
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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 laparoscopic anti-reflux surgery in people with Gastroesophageal Reflux Disease and Laparoscopic Antireflux Surgery, 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 6 inclusion and 3 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 23 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?
On the ClinicalTrials.gov record for NCT01321294, which also lists 1 linked publication.
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 23 Mar 2011.