Back to resultsEsophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
Primary Purpose
Dysphagia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Esophageal calibration tube
Sponsored by
About this trial
This is an interventional prevention trial for Dysphagia focused on measuring Laparoscopic Nissen fundoplication, Esophageal calibration, Postoperative dysphagia
Eligibility Criteria
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
Sites / Locations
- Antalya Training and Research Hospital, Department of 2nd General Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
esophageal calibration
Control
Arm Description
Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation
Standard Laparoscopic Nissen fundoplication without esophageal calibration
Outcomes
Primary Outcome Measures
dysphagia severity score
This score system is used to assess the severity of dysphagia
Secondary Outcome Measures
Full Information
NCT ID
NCT01501071
First Posted
December 27, 2011
Last Updated
December 28, 2011
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01501071
Brief Title
Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
Official Title
Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Laparoscopic Nissen fundoplication, Esophageal calibration, Postoperative dysphagia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esophageal calibration
Arm Type
Experimental
Arm Description
Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard Laparoscopic Nissen fundoplication without esophageal calibration
Intervention Type
Device
Intervention Name(s)
Esophageal calibration tube
Other Intervention Name(s)
A.M.I.Gastric tube code: AGB 355
Intervention Description
An orogastric calibration tube is inserted during laparoscopic Nissen fundoplication in order to secure a certain esophageal lumen for reducing postoperative dysphagia
Primary Outcome Measure Information:
Title
dysphagia severity score
Description
This score system is used to assess the severity of dysphagia
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurullah Bulbuller, MD
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Antalya Training and Research Hospital, Department of 2nd General Surgery
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
984016
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Links:
URL
http://www.antalyaeah.gov.tr/
Description
Home page of the Antalya training and research hospital
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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
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