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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01501071
Enrollment
50
Registered
2011-12-29
Start date
2009-01-31
Completion date
2011-11-30
Last updated
2011-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Laparoscopic Nissen fundoplication, Esophageal calibration, Postoperative dysphagia

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.

Interventions

DEVICEEsophageal calibration tube

An orogastric calibration tube is inserted during laparoscopic Nissen fundoplication in order to secure a certain esophageal lumen for reducing postoperative dysphagia

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
dysphagia severity scoreone yearThis score system is used to assess the severity of dysphagia

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026