Gastroesophageal Reflux DiseasePhase 4NCT00872755
Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)
A Phase 4 study testing Nissen and Gastropexy in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia, Barrett's Esophagus
- What is being tested?
- Nissen and Gastropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2002to Dec 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Indications for surgical treatment of GERD
- ASA I, II
Who cannot join
- ASA III, IV
- Previous gastric procedures
- Conversion to open procedure
Trial locations and contacts
1 site in 1 country.
Greece1 site
G. Hatzikosta General Hospital Department of Surgery
Ioannina, Epirus, 45001
About this study
Official title: Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease
Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia, Barrett's Esophagus, Esophagitis, Dysphagia
- Being tested
- Nissen, Gastropexy
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal, Barrett Esophagus, Esophagitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NissenProcedure or surgery
Laparoscopic Nissen Fundoplication
GastropexyProcedure or surgery
posterior gastropexy
| Study group | Role | What they receive |
|---|---|---|
| Nissen | Active comparator | Laparoscopic Nissen Fundoplication Receives: Procedure: Nissen |
| Gastropexy | Active comparator | Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy Receives: Procedure: Nissen; Procedure: Gastropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD
Measured: 9-94 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startJan 2002
- Primary completionApr 2008
- Study completionDec 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Hatzikosta General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Evangelos C. Tsimoyiannis, M.D. chairman, Study chair, G. Hatzikosta General Hospital, Ioannina, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872755
- Sponsor's protocol ID
- GH-1948-02
- Other IDs
- GHDS-12345-2
- Status last verified
- Mar 2009
- First submitted
- 30 Mar 2009
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsimogiannis KE, Pappas-Gogos GK, Benetatos N, Tsironis D, Farantos C, Tsimoyiannis EC. Laparoscopic Nissen fundoplication combined with posterior gastropexy in surgical treatment of GERD. Surg Endosc. 2010 Jun;24(6):1303-9. doi: 10.1007/s00464-009-0764-0. Epub 2009 Dec 4.
PubMed 19960205
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00872755
- Acronym / sponsor ID
- GH-1948-02
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia, Barrett's Esophagus, Esophagitis, Dysphagia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- G. Hatzikosta General HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Mar 2009 (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.
Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nissen | Active comparator | Procedure: NissenLaparoscopic Nissen Fundoplication |
| Gastropexy | Active comparator | Procedure: Nissen, Procedure: GastropexyProcedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Indications for surgical treatment of GERD
- ASA I, II
Key exclusion criteria (3 listed)
- ASA III, IV
- Previous gastric procedures
- Conversion to open procedure
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 |
|---|---|---|
| NissenLaparoscopic Nissen Fundoplication | Procedure or surgery | Gastropexy, Nissen |
| Gastropexyposterior gastropexy | Procedure or surgery | Gastropexy |
Primary outcome
Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD
Time frame: 9-94 months postoperatively
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 31 Mar 2009.
- Derived from this study: PubMed 19960205Tsimogiannis KE, Pappas-Gogos GK, Benetatos N, Tsironis D, Farantos C, Tsimoyiannis EC. Laparoscopic Nissen fundoplication combined with posterior gastropexy in surgical treatment of GERD. Surg Endosc. 2010 Jun;24(6):1303-9. doi: 10.1007/s00464-009-0764-0. Epub 2009 Dec 4.
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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.
Evangelos C. Tsimoyiannis, M.D. chairman study chair
G. Hatzikosta General Hospital, Ioannina, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nissen and Gastropexy in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by G. Hatzikosta General Hospital at 1 site in Greece.
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 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 31 Mar 2009. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD (time frame: 9-94 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00872755, 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 31 Mar 2009.