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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480285
First Posted: May 30, 2007
Last Update Posted: May 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese University of Hong Kong
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux Disease Procedure: Laparoscopic Nissen Fundoplication Procedure: Laparoscopic anterior partial fundoplication Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Recurrence of gastroesophageal reflux disease that required medication therapy [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: November 2011
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480285


Contacts
Contact: Philip W Chiu, FRCSEd (852)26322627 philipchiu@surgery.cuhk.edu.hk
Contact: Enders K Ng, MD (852)26322627 endersng@surgery.cuhk.edu.hk

Locations
Hong Kong
Philip Chiu Recruiting
Hong Kong, Hong Kong
Contact: Philip W Chiu, FRCSEd    (852)26322627    philipchiu@surgery.cuhk.edu.hk   
Principal Investigator: Philip W Chiu, FRCSEd         
Sub-Investigator: Enders K Ng, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Philip W Chiu, FRCSEd Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong
  More Information

ClinicalTrials.gov Identifier: NCT00480285     History of Changes
Other Study ID Numbers: CRE2006.287-T
First Submitted: May 29, 2007
First Posted: May 30, 2007
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by Chinese University of Hong Kong:
Gastroesophageal reflux disease
Laparoscopic Nissen Fundoplication
Laparoscopic anterior partial fundoplication

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases