Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication
Sponsor
Turku University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01230944
Collaborator
(none)
110
1
2
56
2
Study Details
Study Description
Brief Summary
This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Conventional Nissen Fundoplication vs. Laparoscopic Nissen Fundoplication: a Prospective Randomized Study, Long-term Follow-up
Study Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Aug 1, 2009
Actual Study Completion Date
:
Aug 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Laparoscopic Nissen Laparoscopic Nissen fundoplication |
Procedure: Laparoscopic Nissen fundoplication
|
| Active Comparator: Open Nissen Open (conventional) Nissen fundoplication |
Procedure: Open Nissen fundoplication
|
Outcome Measures
Primary Outcome Measures
- Subjective symptomatic outcome [15 years]
Evaluation of the symptomatic outcome and the patient satisfaction of the surgical treatment using a structured questionnaire
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Turku University Hospital | Turku | Finland |
Sponsors and Collaborators
- Turku University Hospital
Investigators
- Principal Investigator: Paulina Salminen, MD, PhD, Turku University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01230944
Other Study ID Numbers:
- 12/2004
First Posted:
Oct 29, 2010
Last Update Posted:
Oct 29, 2010
Last Verified:
Oct 1, 2010
Keywords provided by ,
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