Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

Not Applicable

Completed

• Conditions: GERD
• Interventions: Procedure: Laparoscopic Nissen fundoplication; Procedure: Open Nissen fundoplication

• Registration Number: NCT01230944
• Lead Sponsor: Turku University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2010-06-24
• Status Verified: 2010-10
• Study First Submitted QC: 2010-10-28
• Last Update Submitted: 2010-10-28
• Study First Posted: 2010-10-29
• Last Update Posted: 2010-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Nissen	Laparoscopic Nissen fundoplication	Laparoscopic Nissen fundoplication
Open Nissen	Open Nissen fundoplication	Open (conventional) Nissen fundoplication

Primary Outcome Measures

Name	Time	Method
Subjective symptomatic outcome	15 years	Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire

Secondary Outcome Measures

Name	Time	Method
Endoscopic evaluation of the fundoplication result	15 years	Evaluation of the endoscopic objective fudnoplication result by an upper gastrointestinal endoscopy
Reoperation rate	15 years
Postoperative proton pump inhibitor (PPI) use	15 years	postoperative PPI use is registered and the need evaluated

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland