Gastroesophageal RefluxNCT00852098
Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels
A study testing Lap Nissen fundoplication with division of short gastric vessels and Laparoscopic Nissen fundoplication without division of short gastric vessels in people with Gastroesophageal Reflux, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Lap Nissen fundoplication with division of short gastric vessels and Laparoscopic Nissen fundoplication without division of short gastric vessels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesBrazil
- Study dates
- Nov 1997to May 2008
- 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
- objective gastroesophageal reflux in adults
Who cannot join
- esophageal motility disorder
- hard stenosis
- previous antireflux surgery
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Federal University of São Paulo - UNIFESP
São Paulo, São Paulo, 04023-071
State Public Server of São Paulo Hospital (HSPE)
São Paulo, São Paulo, 04025-000
About this study
Official title: Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation
Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Lap Nissen fundoplication with division of short gastric vessels, Laparoscopic Nissen fundoplication without division of short gastric vessels
- Keywords
- Fundoplication, gastroesophageal reflux, gastric vessels, 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.
Lap Nissen fundoplication with division of short gastric vesselsProcedure or surgery
Also called Fundoplication, Gastroesophageal Reflux,Surgery
Dividing short gastric vessels
Laparoscopic Nissen fundoplication without division of short gastric vesselsProcedure or surgery
Also called Fundoplication, Gastroesophageal Reflux,Surgery
non-dividing short gastric vessels
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | dividing short gastric vessels Receives: Procedure: Lap Nissen fundoplication with division of short gastric vessels |
| 2 | Active comparator | non-dividing short gastric vessels Receives: Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.
Measured: two years
Secondary outcomes (1)
Long-term clinical and endoscopic outcome
Measured: 8-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startNov 1997
- Primary completionJan 2000
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital State Public
- Investigators
- José Carlos DelGrande, MD, Study director, Federal University of São PauloMichelle L DeOliveira, MD, Study chair, Federal University of São PauloFrancisco Farah, MD, Principal investigator, Federal University of São PauloRenato Lupinacci, MD, Study chair, Hospital State Public Server São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852098
- Sponsor's protocol ID
- 1069/06
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg. 2008 Jan;247(1):38-42. doi: 10.1097/SLA.0b013e31814a693e.
PubMed 18156921O'Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up. Ann Surg. 2002 Feb;235(2):165-70. doi: 10.1097/00000658-200202000-00001.
PubMed 11807353Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section. Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7. doi: 10.1001/archsurg.139.11.1160.
PubMed 15545560Farah JF, Grande JC, Goldenberg A, Martinez JC, Lupinacci RA, Matone J. Randomized trial of total fundoplication and fundal mobilization with or without division of short gastric vessels: a short-term clinical evaluation. Acta Cir Bras. 2007 Nov-Dec;22(6):422-9. doi: 10.1590/s0102-86502007000600002.
PubMed 18235928
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation
- ClinicalTrials.gov ID
- NCT00852098
- Acronym / sponsor ID
- 1069/06
- Conditions
- Gastroesophageal Reflux
- Keywords
- Fundoplication, gastroesophageal reflux, gastric vessels, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Hospital State Public
- Study start
- Nov 1997
- Primary completion
- Jan 2000 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Feb 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.
Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Lap Nissen fundoplication with division of short gastric vesselsdividing short gastric vessels |
| 2 | Active comparator | Procedure: Laparoscopic Nissen fundoplication without division of short gastric vesselsnon-dividing short gastric vessels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- objective gastroesophageal reflux in adults
Key exclusion criteria (3 listed)
- esophageal motility disorder
- hard stenosis
- previous antireflux 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 |
|---|---|---|
| Lap Nissen fundoplication with division of short gastric vesselsAlso: Fundoplication, Gastroesophageal Reflux,SurgeryDividing short gastric vessels | Procedure or surgery | 1 |
| Laparoscopic Nissen fundoplication without division of short gastric vesselsAlso: Fundoplication, Gastroesophageal Reflux,Surgerynon-dividing short gastric vessels | Procedure or surgery | 2 |
Primary outcome
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.
Time frame: two years
1 secondary outcome
Long-term clinical and endoscopic outcome
Time frame: 8-10 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 26 Feb 2009.
- Background: PubMed 18156921Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg. 2008 Jan;247(1):38-42. doi: 10.1097/SLA.0b013e31814a693e.
- Background: PubMed 11807353O'Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up. Ann Surg. 2002 Feb;235(2):165-70. doi: 10.1097/00000658-200202000-00001.
- Background: PubMed 15545560Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section. Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7. doi: 10.1001/archsurg.139.11.1160.
- Results publication: PubMed 18235928Farah JF, Grande JC, Goldenberg A, Martinez JC, Lupinacci RA, Matone J. Randomized trial of total fundoplication and fundal mobilization with or without division of short gastric vessels: a short-term clinical evaluation. Acta Cir Bras. 2007 Nov-Dec;22(6):422-9. doi: 10.1590/s0102-86502007000600002.
- Related InfoLink 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.
José Carlos DelGrande, MD study director
Federal University of São Paulo
Michelle L DeOliveira, MD study chair
Federal University of São Paulo
Francisco Farah, MD principal investigator
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lap Nissen fundoplication with division of short gastric vessels and Laparoscopic Nissen fundoplication without division of short gastric vessels in people with Gastroesophageal Reflux, run by Federal University of São Paulo at 2 sites in Brazil.
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 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 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels. (time frame: two years). 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 NCT00852098, which also lists 4 linked publications.
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 26 Feb 2009.