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

NCT00480285 | Unknown Phase 3 DMC

• 1 other identifier: CRE2006.287-T
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease; Laparoscopic Nissen Fundoplication; Laparoscopic anterior partial fundoplication

Outcome Measures

Primary Outcomes (1)

• Recurrence of gastroesophageal reflux disease that required medication therapy

  5 years

Secondary Outcomes (6)

• 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

Interventions

Laparoscopic Nissen Fundoplication PROCEDURE

Laparoscopic anterior partial fundoplication PROCEDURE

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Philip Chiu

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Philip W Chiu, FRCSEd

  Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip W Chiu, FRCSEd

CONTACT

(852)26322627; philipchiu@surgery.cuhk.edu.hk

Enders K Ng, MD

CONTACT

(852)26322627; endersng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 30, 2007
• Study Start: November 1, 2006
• Study Completion: November 1, 2011
• Last Updated: May 30, 2007

Record last verified: 2007-05

Locations

HK (1)