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OpenTrials
Completed

NCT Number: NCT01230944

Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

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

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Laparoscopic Nissen fundoplication

Procedure

open Nissen fundoplication

Procedure

Primary outcomes

  1. Subjective symptomatic outcome

    Time frame: 15 years

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

Secondary outcomes

  1. Endoscopic evaluation of the fundoplication result

    Time frame: 15 years

    Evaluation of the endoscopic objective fudnoplication result by an upper gastrointestinal endoscopy

  2. Reoperation rate

    Time frame: 15 years

  3. Postoperative proton pump inhibitor (PPI) use

    Time frame: 15 years

    postoperative PPI use is registered and the need evaluated

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 29, 2010
Registry last updated
Oct 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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