Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nurullah Bulbuller, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01501071
First received: December 27, 2011
Last updated: December 28, 2011
Last verified: December 2011

December 27, 2011
December 28, 2011
January 2009
November 2010   (final data collection date for primary outcome measure)
dysphagia severity score [ Time Frame: one year ] [ Designated as safety issue: No ]
This score system is used to assess the severity of dysphagia
Same as current
Complete list of historical versions of study NCT01501071 on ClinicalTrials.gov Archive Site
Not Provided
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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia

Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic Nissen fundoplication became the standard surgical treatment of this disease. Although being almost transient postoperative dysphagia is still a common complaint following this procedure. The aim of this study is to investigate the effect of inserting a soft structured and blunt mounted 39 F orogastric tube to postoperative dysphagia.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Dysphagia
Device: Esophageal calibration tube
An orogastric calibration tube is inserted during laparoscopic Nissen fundoplication in order to secure a certain esophageal lumen for reducing postoperative dysphagia
Other Name: A.M.I.Gastric tube code: AGB 355
  • Experimental: esophageal calibration
    Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation
    Intervention: Device: Esophageal calibration tube
  • No Intervention: Control
    Standard Laparoscopic Nissen fundoplication without esophageal calibration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2011
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Grade 3 or more esophagitis
  • Hiatal hernia larger than 3 centimeters
  • Acide suppression therapy history longer than 2 years

Exclusion Criteria:

  • Story of endoscopic mucosal resection for Barret's mucosa
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01501071
001
No
Nurullah Bulbuller, Antalya Training and Research Hospital
Antalya Training and Research Hospital
Not Provided
Study Director: Nurullah Bulbuller, MD Antalya Training and Research Hospital
Antalya Training and Research Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP