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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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Antalya Training and Research Hospital:

Primary Outcome Measures:
  • dysphagia severity score [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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
Study First Received: December 27, 2011
Last Updated: December 28, 2011
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014