Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

October 28, 2010 updated by: Turku University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic Nissen
Laparoscopic Nissen fundoplication
Procedure: Laparoscopic Nissen fundoplication
Active Comparator: Open Nissen
Open (conventional) Nissen fundoplication
Procedure: Open Nissen fundoplication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective symptomatic outcome
Time Frame: 15 years
Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire
15 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Paulina Salminen, MD, PhD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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