Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

NCT01501071 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

Laparoscopic Nissen fundoplication; Esophageal calibration; Postoperative dysphagia

Outcome Measures

Primary Outcomes (1)

• dysphagia severity score

  This score system is used to assess the severity of dysphagia

  one year

Study Arms (2)

esophageal calibration

EXPERIMENTAL

Esophageal calibration tube was applied to this group of patients during laparoscopic Nissen fundoplication operation

Device: Esophageal calibration tube

Control

NO INTERVENTION

Standard Laparoscopic Nissen fundoplication without esophageal calibration

Interventions

Esophageal calibration tube DEVICE

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

Also known as: A.M.I.Gastric tube code: AGB 355

esophageal calibration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Grade 3 or more esophagitis
• Hiatal hernia larger than 3 centimeters
• Acide suppression therapy history longer than 2 years

You may not qualify if:

• Story of endoscopic mucosal resection for Barret's mucosa

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of 2nd General Surgery

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (17)

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  PMID: 11591970 BACKGROUND

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  PMID: 16230543 BACKGROUND

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  PMID: 8678618 BACKGROUND

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  PMID: 10982510 BACKGROUND

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  PMID: 10204561 BACKGROUND

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  PMID: 8554418 BACKGROUND

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  PMID: 8864089 BACKGROUND

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  PMID: 10088561 BACKGROUND

• Somasekar K, Morris-Stiff G, Al-Madfai H, Barton K, Hassn A. Is a bougie required for the performance of the fundal wrap during laparoscopic Nissen fundoplication? Surg Endosc. 2010 Feb;24(2):390-4. doi: 10.1007/s00464-009-0592-2. Epub 2009 Jun 24.

  PMID: 19551431 BACKGROUND

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  PMID: 3729589 BACKGROUND

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  PMID: 18973468 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Nurullah Bulbuller, MD

  Antalya Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

TU (1)