Clinical trial NCT00852098: Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels
Official title: Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Fundoplication
gastroesophageal reflux
gastric vessels
surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Hospital State Public
First posted: 2009-02-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* objective gastroesophageal reflux in adults

Exclusion Criteria:

* esophageal motility disorder
* hard stenosis
* previous antireflux surgery

Primary outcomes:
measure: Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.
timeFrame: two years
Secondary outcomes:
measure: Long-term clinical and endoscopic outcome
timeFrame: 8-10 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo - UNIFESP
city: São Paulo
country: Brazil
facility: State Public Server of São Paulo Hospital (HSPE)
Study officials:
affiliation: Federal University of São Paulo
name: José Carlos DelGrande, MD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Michelle L DeOliveira, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Francisco Farah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital State Public Server São Paulo
name: Renato Lupinacci, MD
role: STUDY_CHAIR
References:
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. doi: 10.1097/SLA.0b013e31814a693e.
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. doi: 10.1097/00000658-200202000-00001.
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. doi: 10.1001/archsurg.139.11.1160.
citation: 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):422-9. doi: 10.1590/s0102-86502007000600002.