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Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

NCT ID: NCT01230944

Last Updated: 2010-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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Conditions

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GERD

Keywords

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GERD LNF CNF Laparoscopic Nissen fundoplication Open Nissen fundoplication Antireflux surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Nissen

Laparoscopic Nissen fundoplication

Group Type ACTIVE_COMPARATOR

Laparoscopic Nissen fundoplication

Intervention Type PROCEDURE

Open Nissen

Open (conventional) Nissen fundoplication

Group Type ACTIVE_COMPARATOR

Open Nissen fundoplication

Intervention Type PROCEDURE

Interventions

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Laparoscopic Nissen fundoplication

Intervention Type PROCEDURE

Open Nissen fundoplication

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Turku University Hospital, Department of Surgery

Principal Investigators

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Paulina Salminen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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12/2004

Identifier Type: -

Identifier Source: org_study_id