Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Device: Esophageal calibration tube

• Registration Number: NCT01501071
• Lead Sponsor: Antalya Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2011-12-28
• Last Update Submitted: 2011-12-28
• Study First Posted: 2011-12-29
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esophageal calibration	Esophageal calibration tube	Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation

Primary Outcome Measures

Name	Time	Method
dysphagia severity score	one year	This score system is used to assess the severity of dysphagia

Trial Locations

Locations (1)

Antalya Training and Research Hospital, Department of 2nd General Surgery; 🇹🇷 Antalya, Turkey