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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00480285 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients |
Estimated Enrollment: | 100 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2011 |
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.
Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Gastroesophageal reflux disease (GERD) as evidence by
Good response to PPI therapy
Exclusion Criteria:
Contact: Philip W Chiu, FRCSEd | (852)26322627 | philipchiu@surgery.cuhk.edu.hk |
Contact: Enders K Ng, MD | (852)26322627 | endersng@surgery.cuhk.edu.hk |
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 |
Principal Investigator: | Philip W Chiu, FRCSEd | Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong |
Study ID Numbers: | CRE2006.287-T |
Study First Received: | May 29, 2007 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00480285 History of Changes |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Gastroesophageal reflux disease Laparoscopic Nissen Fundoplication Laparoscopic anterior partial fundoplication |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |