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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Laparoscopic Nissen Fundoplication
Laparoscopic anterior partial fundoplication
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux disease, Laparoscopic Nissen Fundoplication, Laparoscopic anterior partial fundoplication

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Philip ChiuRecruiting

Outcomes

Primary Outcome Measures

Recurrence of gastroesophageal reflux disease that required medication therapy

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

Full Information

First Posted
May 29, 2007
Last Updated
May 29, 2007
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00480285
Brief Title
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
Official Title
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Gastroesophageal reflux disease, Laparoscopic Nissen Fundoplication, Laparoscopic anterior partial fundoplication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Nissen Fundoplication
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic anterior partial fundoplication
Primary Outcome Measure Information:
Title
Recurrence of gastroesophageal reflux disease that required medication therapy
Time Frame
5 years
Secondary Outcome Measure Information:
Title
1. Dysphagia - measured by the 4-point Likert scale (0 - no dysphagia,1 - mild dysphagia, 2 - moderate dysphagia, 3 - severe dysphagia)
Title
2. Ability to bloat / belch
Title
3. Overall Satisfaction - (0 - Very satisfactory, 1 - Good, 2 - no comment, 3 - Unsatisfactory)
Title
4. Quality of life score - measure by SF36 before operation, 6 months and 12 months after operation
Title
5. GERD related QoL assessment
Title
6. Perioperative outcomes - hospital stay, operative time, morbidity, mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 16 and < 70 Gastroesophageal reflux disease (GERD) as evidence by Typical symptoms including heartburn &/or acid regurgitation &/or acid in throat 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip W Chiu, FRCSEd
Phone
(852)26322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Enders K Ng, MD
Phone
(852)26322627
Email
endersng@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip W Chiu, FRCSEd
Organizational Affiliation
Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philip Chiu
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip W Chiu, FRCSEd
Phone
(852)26322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Philip W Chiu, FRCSEd
First Name & Middle Initial & Last Name & Degree
Enders K Ng, MD

12. IPD Sharing Statement

Learn more about this trial

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

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