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Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501071
First Posted: December 29, 2011
Last Update Posted: December 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nurullah Bulbuller, Antalya Training and Research Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • dysphagia severity score [ Time Frame: one year ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6.
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. doi: 10.1007/s00464-009-0592-2. 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. doi: 10.1089/lap.2007.0135.

Responsible Party: Nurullah Bulbuller, Clinical director, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01501071     History of Changes
Other Study ID Numbers: 001
First Submitted: December 27, 2011
First Posted: December 29, 2011
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Nurullah Bulbuller, 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


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