NCT01230944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

4.7 years

First QC Date

June 24, 2010

Last Update Submit

October 28, 2010

Conditions

GERD

Keywords

GERDLNFCNFLaparoscopic Nissen fundoplicationOpen Nissen fundoplicationAntireflux surgery

Outcome Measures

Primary Outcomes (1)

  • Subjective symptomatic outcome

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

    15 years

Secondary Outcomes (3)

  • Endoscopic evaluation of the fundoplication result

    15 years

  • Reoperation rate

    15 years

  • Postoperative proton pump inhibitor (PPI) use

    15 years

Study Arms (2)

Laparoscopic Nissen

ACTIVE COMPARATOR

Laparoscopic Nissen fundoplication

Procedure: Laparoscopic Nissen fundoplication

Open Nissen

ACTIVE COMPARATOR

Open (conventional) Nissen fundoplication

Procedure: Open Nissen fundoplication

Interventions

Laparoscopic Nissen fundoplicationPROCEDURE
Laparoscopic Nissen
Open Nissen fundoplicationPROCEDURE
Open Nissen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Paulina Salminen, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 24, 2010

First Posted

October 29, 2010

Study Start

December 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations

FI(1)