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NCT01230944 Clinical Trial

Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

GERD Clinical Trial

Official title:
Conventional Nissen Fundoplication vs. Laparoscopic Nissen Fundoplication: a Prospective Randomized Study, Long-term Follow-up

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01230944
Other study ID # 12/2004
Secondary ID
Status Completed
Phase N/A
First received June 24, 2010
Last updated October 28, 2010
Start date December 2004
Est. completion date August 2009

Study information
Verified date October 2010
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority "Turku University Hospital Ethics Committee" Finland':'
Study type Interventional

Clinical Trial Summary

This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic Nissen fundoplication

• Open Nissen fundoplication

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective symptomatic outcome Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire 15 years No
Secondary Endoscopic evaluation of the fundoplication result Evaluation of the endoscopic objective fudnoplication result by an upper gastrointestinal endoscopy 15 years No
Secondary Reoperation rate 15 years Yes
Secondary Postoperative proton pump inhibitor (PPI) use postoperative PPI use is registered and the need evaluated 15 years
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