Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

Gastroesophageal Reflux Clinical Trial

Official title:

Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852098
• Other study ID #: 1069/06
• Status: Completed
• Phase: N/A
• First received: February 25, 2009
• Last updated: February 25, 2009
• Start date: November 1997
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2008
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• objective gastroesophageal reflux in adults

Exclusion Criteria:

• esophageal motility disorder

• hard stenosis

• previous antireflux surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• Lap Nissen fundoplication with division of short gastric vessels
Dividing short gastric vessels
• Laparoscopic Nissen fundoplication without division of short gastric vessels
non-dividing short gastric vessels

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo - UNIFESP	São Paulo
Brazil	State Public Server of São Paulo Hospital (HSPE)	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Hospital State Public

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Farah JF, Grande JC, Goldenberg A, Martinez JC, Lupinacci RA, Matone J. Randomized trial of total fundoplication and fundal mobilization with or without division of short gastric vessels: a short-term clinical evaluation. Acta Cir Bras. 2007 Nov-Dec;22(6) — View Citation

O'Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up. Ann Surg. 2002 Feb;235(2):165-70. — View Citation

Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section. Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7. — View Citation

Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg. 2008 Jan;247(1):38-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.		two years	Yes
Secondary	Long-term clinical and endoscopic outcome		8-10 years	Yes

External Links

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