Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480285
Status:
UNKNOWN
Last Update Posted:
2007-05-30
First Post:
2007-05-29
Brief Title:
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None