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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 29, 2011
Last Update Posted: December 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nurullah Bulbuller, Antalya Training and Research Hospital
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 Intervention
Dysphagia Device: Esophageal calibration tube

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Nurullah Bulbuller, Antalya Training and Research Hospital:

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

Enrollment: 50
Study Start Date: January 2009
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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

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

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Rattner DW. Measuring improved quality of life after laparoscopic Nissen fundoplication. Surgery. 2000 Mar;127(3):258-63.
Terry M, Smith CD, Branum GD, Galloway K, Waring JP, Hunter JG. Outcomes of laparoscopic fundoplication for gastroesophageal reflux disease and paraesophageal hernia. Surg Endosc. 2001 Jul;15(7):691-9. Epub 2001 May 7.
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Gotley DC, Smithers BM, Rhodes M, Menzies B, Branicki FJ, Nathanson L. Laparoscopic Nissen fundoplication--200 consecutive cases. Gut. 1996 Apr;38(4):487-91.
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Hunter JG, Swanstrom L, Waring JP. Dysphagia after laparoscopic antireflux surgery. The impact of operative technique. Ann Surg. 1996 Jul;224(1):51-7.
Patterson EJ, Herron DM, Hansen PD, Ramzi N, Standage BA, Swanström LL. Effect of an esophageal bougie on the incidence of dysphagia following nissen fundoplication: a prospective, blinded, randomized clinical trial. Arch Surg. 2000 Sep;135(9):1055-61; discussion 1061-2.
Richardson WS, Hunter JG. Laparoscopic floppy Nissen fundoplication. Am J Surg. 1999 Feb;177(2):155-7.
Schauer PR, Meyers WC, Eubanks S, Norem RF, Franklin M, Pappas TN. Mechanisms of gastric and esophageal perforations during laparoscopic Nissen fundoplication. Ann Surg. 1996 Jan;223(1):43-52.
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Somasekar K, Morris-Stiff G, Al-Madfai H, Barton K, Hassn A. Is a bougie required for the performance of the fundal wrap during laparoscopic Nissen fundoplication? Surg Endosc. 2010 Feb;24(2):390-4. doi: 10.1007/s00464-009-0592-2. Epub 2009 Jun 24.
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Responsible Party: Nurullah Bulbuller, Clinical director, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01501071     History of Changes
Other Study ID Numbers: 001
First Submitted: December 27, 2011
First Posted: December 29, 2011
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

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