Clinical trial NCT01501071: Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia
Official title: Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Laparoscopic Nissen fundoplication
Esophageal calibration
Postoperative dysphagia
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2011-12-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: dysphagia severity score
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of 2nd General Surgery
Study officials:
affiliation: Antalya Training and Research Hospital
name: Nurullah Bulbuller, MD
role: STUDY_DIRECTOR
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