Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

This study has been completed.

Sponsor:

Information provided by:

Turku University Hospital

ClinicalTrials.gov Identifier:

NCT01230944

First received: June 24, 2010

Last updated: October 28, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 24, 2010

Last Updated Date

October 28, 2010

Start Date ^ICMJE

December 2004

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subjective symptomatic outcome [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01230944 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Endoscopic evaluation of the fundoplication result [ Time Frame: 15 years ] [ Designated as safety issue: No ]
Evaluation of the endoscopic objective fudnoplication result by an upper gastrointestinal endoscopy
Reoperation rate [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
Postoperative proton pump inhibitor (PPI) use [ Time Frame: 15 years ]
postoperative PPI use is registered and the need evaluated

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

GERD

Intervention ^ICMJE

Procedure: Laparoscopic Nissen fundoplication
Procedure: Open Nissen fundoplication

Study Arm (s)

Active Comparator: Laparoscopic Nissen
Laparoscopic Nissen fundoplication

Intervention: Procedure: Laparoscopic Nissen fundoplication
Active Comparator: Open Nissen
Open (conventional) Nissen fundoplication

Intervention: Procedure: Open Nissen fundoplication

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01230944

Other Study ID Numbers ^ICMJE

12/2004

Has Data Monitoring Committee

Responsible Party

Paulina Salminen, Turku University Hospital, Department of Surgery

Study Sponsor ^ICMJE

Turku University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Paulina Salminen, MD, PhD

Turku University Hospital

Information Provided By

Turku University Hospital

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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