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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00480285
• Other study ID #: CRE2006.287-T
• Status: Recruiting
• Phase: Phase 3
• First received: May 29, 2007
• Last updated: May 29, 2007
• Start date: November 2006
• Est. completion date: November 2011

Study information

• Verified date: May 2007
• Source: Chinese University of Hong Kong
• Contact: Philip W Chiu, FRCSEd
• Phone: (852)26322627
• Email: philipchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical 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 disease

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• Laparoscopic Nissen Fundoplication

• Laparoscopic anterior partial fundoplication

Locations

Country	Name	City	State
Hong Kong	Philip Chiu	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of gastroesophageal reflux disease that required medication therapy		5 years
Secondary	1. Dysphagia – measured by the 4-point Likert scale (0 - no dysphagia,1 - mild dysphagia, 2 - moderate dysphagia, 3 - severe dysphagia)
Secondary	2. Ability to bloat / belch
Secondary	3. Overall Satisfaction – (0 – Very satisfactory, 1 – Good, 2 – no comment, 3 – Unsatisfactory)
Secondary	4. Quality of life score – measure by SF36 before operation, 6 months and 12 months after operation
Secondary	5. GERD related QoL assessment
Secondary	6. Perioperative outcomes – hospital stay, operative time, morbidity, mortality