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

May 29, 2007 updated by: Chinese University of Hong Kong

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Philip Chiu
        • Contact:
        • Principal Investigator:
          • Philip W Chiu, FRCSEd
        • Sub-Investigator:
          • Enders K Ng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of gastroesophageal reflux disease that required medication therapy
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Philip W Chiu, FRCSEd, Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (ESTIMATE)

May 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2007

Last Update Submitted That Met QC Criteria

May 29, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE2006.287-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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