Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01230944

Enrollment

110

Registered

2010-10-29

Start date

2004-12-31

Completion date

2009-08-31

Last updated

2010-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

GERD, LNF, CNF, Laparoscopic Nissen fundoplication, Open Nissen fundoplication, Antireflux surgery

Brief summary

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

Interventions

PROCEDURELaparoscopic Nissen fundoplication

PROCEDUREOpen Nissen fundoplication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026