NCT01321294

Brief Summary

The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

March 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

First QC Date

March 21, 2011

Last Update Submit

March 22, 2011

Conditions

Gastroesophageal Reflux DiseaseLaparoscopic Antireflux Surgery

Study Arms (2)

Nissen fundoplication

ACTIVE COMPARATOR
Procedure: laparoscopic anti-reflux surgery

Toupet fundoplication

ACTIVE COMPARATOR
Procedure: laparoscopic anti-reflux surgery

Interventions

laparoscopic anti-reflux surgeryPROCEDURE
Nissen fundoplicationToupet fundoplication

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of gastroesophageal reflux disease
  • Long history of GERD symptoms
  • Persistent or recurrent symptoms despite optimal medical treatment
  • Persistent or recurrent complications of GERD
  • Reduced quality of life owing to increasing esophageal exposure to gastric juice
  • Pathological values in the preoperative evaluated functional parameters

You may not qualify if:

  • Previous esophageal or gastric surgery
  • Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Public Hospital Zell am See

Zell am See, Salzburg, 5700, Austria

Location

Related Publications (1)

  • Koch OO, Kaindlstorfer A, Antoniou SA, Luketina RR, Emmanuel K, Pointner R. Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications. Surg Endosc. 2013 Jul;27(7):2383-90. doi: 10.1007/s00464-013-2803-0. Epub 2013 Jan 30.

    PMID: 23361260DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 23, 2011

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

AU(1)