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A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients

A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00480285
Enrollment
100
Registered
2007-05-30
Start date
2006-11-30
Completion date
2011-11-30
Last updated
2007-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease, Laparoscopic Nissen Fundoplication, Laparoscopic anterior partial fundoplication

Brief 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 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.

Interventions

PROCEDURELaparoscopic anterior partial fundoplication

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 16 and \< 70 * Gastroesophageal reflux disease (GERD) as evidence by 1. Typical symptoms including heartburn &/or acid regurgitation &/or acid in throat 2. 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 3. Not able to wean off PPI to on-demand regimen

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
Recurrence of gastroesophageal reflux disease that required medication therapy5 years

Secondary

MeasureTime frame
2. Ability to bloat / belch
3. Overall Satisfaction - (0 - Very satisfactory, 1 - Good, 2 - no comment, 3 - Unsatisfactory)
1. Dysphagia - measured by the 4-point Likert scale (0 - no dysphagia,1 - mild dysphagia, 2 - moderate dysphagia, 3 - severe dysphagia)
5. GERD related QoL assessment
6. Perioperative outcomes - hospital stay, operative time, morbidity, mortality
4. Quality of life score - measure by SF36 before operation, 6 months and 12 months after operation

Countries

Hong Kong

Contacts

Primary ContactPhilip W Chiu, FRCSEd
philipchiu@surgery.cuhk.edu.hk(852)26322627
Backup ContactEnders K Ng, MD
endersng@surgery.cuhk.edu.hk(852)26322627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026