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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

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ClinicalTrials.gov Identifier: NCT01501071
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : December 29, 2011
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Dysphagia Device: Esophageal calibration tube

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia
Study Start Date : January 2009
Primary Completion Date : November 2010
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: esophageal calibration
Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation
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
No Intervention: Control
Standard Laparoscopic Nissen fundoplication without esophageal calibration


Outcome Measures

Primary Outcome Measures :
  1. dysphagia severity score [ Time Frame: one year ]
    This score system is used to assess the severity of dysphagia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501071


Locations
Turkey
Antalya Training and Research Hospital, Department of 2nd General Surgery
Antalya, Turkey, 07100
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
Study Director: Nurullah Bulbuller, MD Antalya Training and Research Hospital
More Information

Publications:

Responsible Party: Nurullah Bulbuller, Clinical director, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01501071     History of Changes
Other Study ID Numbers: 001
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Nurullah Bulbuller, Antalya Training and Research Hospital:
Laparoscopic Nissen fundoplication
Esophageal calibration
Postoperative dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases