Gastroesophageal Reflux DiseasePhase 3NCT00480285
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
A Phase 3 study testing Laparoscopic Nissen Fundoplication and Laparoscopic anterior partial fundoplication in people with Gastroesophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this study is to compare the effectiveness of laparoscopic Nissen against anterior partial fundoplication in the control of gastroesophageal reflux disease among Chinese patients Study hypothesis Laparoscopic Nissen is comparable to anterior partial fundoplication in the control of gastroesophageal reflux… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic Nissen Fundoplication and Laparoscopic anterior partial fundoplication
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2006to Nov 2011
- Phase
- Phase 3
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 16 and < 70
- Gastroesophageal reflux disease (GERD) as evidence by
- Typical symptoms including heartburn \&/or acid regurgitation \&/or acid in throat
- Good response to PPI therapy
- Defined as a complete cessation of GERD symptoms (as above) with 4 weeks of high dose PPI
- PPI - standardized to Esomeprazole 40mg daily
- Not able to wean off PPI to on-demand regimen
Who cannot join
- Achalasia
- Moribund patients
- Pregnancy
- Previous gastrectomy / esophagectomy
- Informed consent not available
- Non-Chinese ethnic group
- Patients with hiatus hernia > 3cm (measured by endoscopy \& / or manometry)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Philip Chiu
Hong Kong
Philip W Chiu, FRCSEd, (852)26322627, philipchiu@surgery.cuhk.edu.hk
Philip W Chiu, FRCSEd
About this study
The aim of this study is to compare the effectiveness of laparoscopic Nissen against anterior partial fundoplication in the control of gastroesophageal reflux disease among Chinese patients
Study hypothesis Laparoscopic Nissen is comparable to anterior partial fundoplication in the control of gastroesophageal reflux disease
Read the detailed description
The incidence of gastroesophageal reflux disease (GERD) is rising among Asian population. A recent systematic review showed among Chinese population, the prevalence of GERD can be up to 5% (2). Currently, the standard treatment for GERD is acid suppression using proton pump inhibitors (PPI) which can achieve a symptomatic relief of more than 90%. However, more than 50% of patients with GERD will required long term PPI. As the usual occurrence of GERD is at the age of 40 to 50, the need of long term PPI among these young adults renders them playing a sick role for a long period of time. This imposed a major impact on these patients' quality of life, and a significant medical expenditure to the society.
Since Rudolf Nissen first reported the use of fundoplication as a treatment of gastroesophageal reflux disease in 1956, there has been a development in variety of different fundoplication. It can be classified into a complete or partial wrapping at the lower esophageal sphincter around the esophago-gastric junction (EGJ). From the results of numerous randomized studies, Fundoplication is considered as an alternative to long term proton pump inhibitors. Recent controversies abound upon the use of partial or complete fundoplication. Several randomized studies reported that a partial fundoplication can reduce the incidence of post-operative dysphagia. However, this benefit is off-set by an increase in the incidence of recurrence. From our retrospective review on 28 patients treated by laparoscopic fundoplication, the recurrence of GERD is significantly higher in patients treated with partial compared to a complete fundoplication. The effectiveness of partial against complete Nissen fundoplication in control of reflux among Chinese patients is still unknown. Our study aimed to compare Laparoscopic Nissen fundoplication against Anterior partial on the control of gastroesophageal reflux disease.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Laparoscopic Nissen Fundoplication, Laparoscopic anterior partial fundoplication
- Keywords
- Gastroesophageal reflux disease, Laparoscopic Nissen Fundoplication, Laparoscopic anterior partial fundoplication
- 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
Laparoscopic anterior partial fundoplicationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of gastroesophageal reflux disease that required medication therapy
Measured: 5 years
Secondary outcomes (6)
1. Dysphagia - measured by the 4-point Likert scale (0 - no dysphagia,1 - mild dysphagia, 2 - moderate dysphagia, 3 - severe dysphagia)
2. Ability to bloat / belch
3. Overall Satisfaction - (0 - Very satisfactory, 1 - Good, 2 - no comment, 3 - Unsatisfactory)
4. Quality of life score - measure by SF36 before operation, 6 months and 12 months after operation
5. GERD related QoL assessment
6. Perioperative outcomes - hospital stay, operative time, morbidity, mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startNov 2006
- Study completionNov 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.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Philip W Chiu, FRCSEd, Principal investigator, Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480285
- Sponsor's protocol ID
- CRE2006.287-T
- Status last verified
- May 2007
- First submitted
- 29 May 2007
- Last updated
- 30 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
- ClinicalTrials.gov ID
- NCT00480285
- Acronym / sponsor ID
- CRE2006.287-T
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux disease, Laparoscopic Nissen Fundoplication, Laparoscopic anterior partial fundoplication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Nov 2011 (estimated)
- First posted
- 30 May 2007 (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 the effectiveness of laparoscopic Nissen against anterior partial fundoplication in the control of gastroesophageal reflux disease among Chinese patients
Study hypothesis Laparoscopic Nissen is comparable to anterior partial fundoplication in the control of gastroesophageal reflux disease
Detailed description
The incidence of gastroesophageal reflux disease (GERD) is rising among Asian population. A recent systematic review showed among Chinese population, the prevalence of GERD can be up to 5% (2). Currently, the standard treatment for GERD is acid suppression using proton pump inhibitors (PPI) which can achieve a symptomatic relief of more than 90%. However, more than 50% of patients with GERD will required long term PPI. As the usual occurrence of GERD is at the age of 40 to 50, the need of long term PPI among these young adults renders them playing a sick role for a long period of time. This imposed a major impact on these patients' quality of life, and a significant medical expenditure to the society.
Since Rudolf Nissen first reported the use of fundoplication as a treatment of gastroesophageal reflux disease in 1956, there has been a development in variety of different fundoplication. It can be classified into a complete or partial wrapping at the lower esophageal sphincter around the esophago-gastric junction (EGJ). From the results of numerous randomized studies, Fundoplication is considered as an alternative to long term proton pump inhibitors. Recent controversies abound upon the use of partial or complete fundoplication. Several randomized studies reported that a partial fundoplication can reduce the incidence of post-operative dysphagia. However, this benefit is off-set by an increase in the incidence of recurrence. From our retrospective review on 28 patients treated by laparoscopic fundoplication, the recurrence of GERD is significantly higher in patients treated with partial compared to a complete fundoplication. The effectiveness of partial against complete Nissen fundoplication in control of reflux among Chinese patients is still unknown. Our study aimed to compare Laparoscopic Nissen fundoplication against Anterior partial on the control of gastroesophageal reflux disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 16 and < 70
- Gastroesophageal reflux disease (GERD) as evidence by
Key exclusion criteria (7 listed)
- Achalasia
- Moribund patients
- Pregnancy
- Previous gastrectomy / esophagectomy
- Informed consent not available
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 anterior partial fundoplication | Procedure or surgery | – |
Primary outcome
Recurrence of gastroesophageal reflux disease that required medication therapy
Time frame: 5 years
6 secondary outcomes
1. Dysphagia - measured by the 4-point Likert scale (0 - no dysphagia,1 - mild dysphagia, 2 - moderate dysphagia, 3 - severe dysphagia)
2. Ability to bloat / belch
3. Overall Satisfaction - (0 - Very satisfactory, 1 - Good, 2 - no comment, 3 - Unsatisfactory)
4. Quality of life score - measure by SF36 before operation, 6 months and 12 months after operation
5. GERD related QoL assessment
6. Perioperative outcomes - hospital stay, operative time, morbidity, mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2007.
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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.
Philip W Chiu, FRCSEd principal investigator
Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic Nissen Fundoplication and Laparoscopic anterior partial fundoplication in people with Gastroesophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 May 2007. 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 Hong Kong. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip W Chiu, FRCSEd ((852)26322627, philipchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of gastroesophageal reflux disease that required medication therapy (time frame: 5 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 30 May 2007.