Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia - Full Text View

Purpose

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	Intervention
Dysphagia	Device: Esophageal calibration tube

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Esophageal Calibration With Soft Orogastric Tube During Laparoscopic Fundoplication Reduces Postoperative Transient Dysphagia

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Swallowing Disorders

U.S. FDA Resources

Further study details as provided by Antalya Training and Research Hospital:

Primary Outcome Measures:

dysphagia severity score [ Time Frame: one year ] [ Designated as safety issue: No ]
This score system is used to assess the severity of dysphagia

Enrollment:	50
Study Start Date:	January 2009
Study Completion Date:	November 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: A.M.I.Gastric tube code: AGB 355
No Intervention: Control Standard Laparoscopic Nissen fundoplication without esophageal calibration

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501071

Locations

Turkey
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

More Information

Additional Information:

Home page of the Antalya training and research hospital This link exits the ClinicalTrials.gov site

Publications:

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Ronkainen J, Aro P, Storskrubb T, Lind T, Bolling-Sternevald E, Junghard O, Talley NJ, Agreus L. Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population--the Kalixanda study. Aliment Pharmacol Ther. 2006 Jun 15;23(12):1725-33.

Rattner DW. Measuring improved quality of life after laparoscopic Nissen fundoplication. Surgery. 2000 Mar;127(3):258-63.

Terry M, Smith CD, Branum GD, Galloway K, Waring JP, Hunter JG. Outcomes of laparoscopic fundoplication for gastroesophageal reflux disease and paraesophageal hernia. Surg Endosc. 2001 Jul;15(7):691-9. Epub 2001 May 7.

Pessaux P, Arnaud JP, Delattre JF, Meyer C, Baulieux J, Mosnier H. Laparoscopic antireflux surgery: five-year results and beyond in 1340 patients. Arch Surg. 2005 Oct;140(10):946-51.

Lafullarde T, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Laparoscopic Nissen fundoplication: five-year results and beyond. Arch Surg. 2001 Feb;136(2):180-4.

Gotley DC, Smithers BM, Rhodes M, Menzies B, Branicki FJ, Nathanson L. Laparoscopic Nissen fundoplication--200 consecutive cases. Gut. 1996 Apr;38(4):487-91.

Watson DI, Pike GK, Baigrie RJ, Mathew G, Devitt PG, Britten-Jones R, Jamieson GG. Prospective double-blind randomized trial of laparoscopic Nissen fundoplication with division and without division of short gastric vessels. Ann Surg. 1997 Nov;226(5):642-52.

Hunter JG, Swanstrom L, Waring JP. Dysphagia after laparoscopic antireflux surgery. The impact of operative technique. Ann Surg. 1996 Jul;224(1):51-7.

Patterson EJ, Herron DM, Hansen PD, Ramzi N, Standage BA, Swanström LL. Effect of an esophageal bougie on the incidence of dysphagia following nissen fundoplication: a prospective, blinded, randomized clinical trial. Arch Surg. 2000 Sep;135(9):1055-61; discussion 1061-2.

Richardson WS, Hunter JG. Laparoscopic floppy Nissen fundoplication. Am J Surg. 1999 Feb;177(2):155-7.

Schauer PR, Meyers WC, Eubanks S, Norem RF, Franklin M, Pappas TN. Mechanisms of gastric and esophageal perforations during laparoscopic Nissen fundoplication. Ann Surg. 1996 Jan;223(1):43-52.

Lowham AS, Filipi CJ, Hinder RA, Swanstrom LL, Stalter K, dePaula A, Hunter JG, Buglewicz TG, Haake K. Mechanisms and avoidance of esophageal perforation by anesthesia personnel during laparoscopic foregut surgery. Surg Endosc. 1996 Oct;10(10):979-82.

Rantanen TK, Salo JA, Salminen JT, Kellokumpu IH. Functional outcome after laparoscopic or open Nissen fundoplication: a follow-up study. Arch Surg. 1999 Mar;134(3):240-4.

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. Epub 2009 Jun 24.

DeMeester TR, Bonavina L, Albertucci M. Nissen fundoplication for gastroesophageal reflux disease. Evaluation of primary repair in 100 consecutive patients. Ann Surg. 1986 Jul;204(1):9-20.

Mathavan VK, Yuh JN, Marks JM. Long-term evaluation of patients undergoing laparoscopic antireflux surgery without bougie placement. J Laparoendosc Adv Surg Tech A. 2009 Feb;19(1):7-12.

Responsible Party:	Nurullah Bulbuller, Clinical director, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier:	NCT01501071 History of Changes
Other Study ID Numbers:	001
Study First Received:	December 27, 2011
Last Updated:	December 28, 2011
Health Authority:	Turkey: Ethics Committee

Keywords provided by Antalya Training and Research Hospital:

Laparoscopic Nissen fundoplication
Esophageal calibration
Postoperative dysphagia

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013