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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

Sponsor
Antalya Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01501071
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
34
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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 Phase
  • Device: Esophageal calibration tube
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2011

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 Names:
  • 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 [one year]

      This score system is used to assess the severity of dysphagia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Nurullah Bulbuller, Clinical director, Antalya Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01501071
    Other Study ID Numbers:
    • 001
    First Posted:
    Dec 29, 2011
    Last Update Posted:
    Dec 29, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by Nurullah Bulbuller, Clinical director, Antalya Training and Research Hospital
    Laparoscopic Nissen fundoplication
    Esophageal calibration
    Postoperative dysphagia
    Additional relevant MeSH terms:
    Deglutition Disorders

    Study Results

    No Results Posted as of Dec 29, 2011