GERDNCT01230944
Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication
A study testing Laparoscopic Nissen fundoplication and Open Nissen fundoplication in people with GERD, run by Turku University Hospital at 1 site in Finland.
Trial summary
This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GERD
- What is being tested?
- Laparoscopic Nissen fundoplication and Open Nissen fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2004to Aug 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Nissen Fundoplication vs. Laparoscopic Nissen Fundoplication: a Prospective Randomized Study, Long-term Follow-up
This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.
- Conditions
- GERD
- Being tested
- Laparoscopic Nissen fundoplication, Open Nissen fundoplication
- Keywords
- GERD, LNF, CNF, Laparoscopic Nissen fundoplication, Open Nissen fundoplication, Antireflux 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 Nissen fundoplicationProcedure or surgery
Open Nissen fundoplicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Nissen | Active comparator | Laparoscopic Nissen fundoplication Receives: Procedure: Laparoscopic Nissen fundoplication |
| Open Nissen | Active comparator | Open (conventional) Nissen fundoplication Receives: Procedure: Open Nissen fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective symptomatic outcome
Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire
Measured: 15 years
Secondary outcomes (3)
Endoscopic evaluation of the fundoplication result
Evaluation of the endoscopic objective fudnoplication result by an upper gastrointestinal endoscopy
Measured: 15 years
Reoperation rate
Measured: 15 years
Postoperative proton pump inhibitor (PPI) use
postoperative PPI use is registered and the need evaluated
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startDec 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Investigators
- Paulina Salminen, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230944
- Sponsor's protocol ID
- 12/2004
- Status last verified
- Oct 2010
- First submitted
- 24 Jun 2010
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Nissen Fundoplication vs. Laparoscopic Nissen Fundoplication: a Prospective Randomized Study, Long-term Follow-up
- ClinicalTrials.gov ID
- NCT01230944
- Acronym / sponsor ID
- 12/2004
- Conditions
- GERD
- Keywords
- GERD, LNF, CNF, Laparoscopic Nissen fundoplication, Open Nissen fundoplication, Antireflux surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Dec 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Oct 2010 (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 is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Nissen | Active comparator | Procedure: Laparoscopic Nissen fundoplicationLaparoscopic Nissen fundoplication |
| Open Nissen | Active comparator | Procedure: Open Nissen fundoplicationOpen (conventional) Nissen fundoplication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment
Key exclusion criteria (0 listed)
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 Nissen fundoplication | Procedure or surgery | Laparoscopic Nissen |
| Open Nissen fundoplication | Procedure or surgery | Open Nissen |
Primary outcome
Subjective symptomatic outcome
Time frame: 15 years
Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire
3 secondary outcomes
Endoscopic evaluation of the fundoplication result
Time frame: 15 years
Reoperation rate
Time frame: 15 years
Postoperative proton pump inhibitor (PPI) use
Time frame: 15 years
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 Oct 2010.
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Paulina Salminen, MD, PhD principal investigator
Turku University Hospital
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 Nissen fundoplication and Open Nissen fundoplication in people with GERD, run by Turku University Hospital at 1 site in Finland.
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 1 inclusion and 0 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 Oct 2010. 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 Finland. 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.
What does the primary outcome measure?
Subjective symptomatic outcome (time frame: 15 years). 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 29 Oct 2010.