Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501071
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: December 27, 2011
• Last updated: December 28, 2011
• Start date: January 2009
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of 2nd General Surgery	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (17)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dysphagia severity score	This score system is used to assess the severity of dysphagia	one year	No

External Links

•   Home page of the Antalya training and research hospital