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

NCT ID: NCT00480285

Last Updated: 2007-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-11-30

Brief Summary

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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

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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

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Gastroesophageal Reflux Disease

Keywords

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Gastroesophageal reflux disease Laparoscopic Nissen Fundoplication Laparoscopic anterior partial fundoplication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Laparoscopic Nissen Fundoplication

Intervention Type PROCEDURE

Laparoscopic anterior partial fundoplication

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Philip W Chiu, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong

Locations

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Philip Chiu

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Philip W Chiu, FRCSEd

Role: CONTACT

Phone: (852)26322627

Email: [email protected]

Enders K Ng, MD

Role: CONTACT

Phone: (852)26322627

Email: [email protected]

Facility Contacts

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Philip W Chiu, FRCSEd

Role: primary

Other Identifiers

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CRE2006.287-T

Identifier Type: -

Identifier Source: org_study_id