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

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lap Nissen fundoplication with division of short gastric vessels
Laparoscopic Nissen fundoplication without division of short gastric vessels
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Fundoplication, gastroesophageal reflux, gastric vessels, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • objective gastroesophageal reflux in adults

Exclusion Criteria:

  • esophageal motility disorder
  • hard stenosis
  • previous antireflux surgery

Sites / Locations

  • Federal University of São Paulo - UNIFESP
  • State Public Server of São Paulo Hospital (HSPE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

dividing short gastric vessels

non-dividing short gastric vessels

Outcomes

Primary Outcome Measures

Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.

Secondary Outcome Measures

Long-term clinical and endoscopic outcome

Full Information

First Posted
February 25, 2009
Last Updated
February 25, 2009
Sponsor
Federal University of São Paulo
Collaborators
Hospital State Public
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1. Study Identification

Unique Protocol Identification Number
NCT00852098
Brief Title
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

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Hospital State Public

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Fundoplication, gastroesophageal reflux, gastric vessels, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
dividing short gastric vessels
Arm Title
2
Arm Type
Active Comparator
Arm Description
non-dividing short gastric vessels
Intervention Type
Procedure
Intervention Name(s)
Lap Nissen fundoplication with division of short gastric vessels
Other Intervention Name(s)
Fundoplication, Gastroesophageal Reflux,Surgery
Intervention Description
Dividing short gastric vessels
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Nissen fundoplication without division of short gastric vessels
Other Intervention Name(s)
Fundoplication, Gastroesophageal Reflux,Surgery
Intervention Description
non-dividing short gastric vessels
Primary Outcome Measure Information:
Title
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Long-term clinical and endoscopic outcome
Time Frame
8-10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: objective gastroesophageal reflux in adults Exclusion Criteria: esophageal motility disorder hard stenosis previous antireflux surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Carlos DelGrande, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michelle L DeOliveira, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francisco Farah, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renato Lupinacci, MD
Organizational Affiliation
Hospital State Public Server São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo - UNIFESP
City
São Paulo
ZIP/Postal Code
04023-071
Country
Brazil
Facility Name
State Public Server of São Paulo Hospital (HSPE)
City
São Paulo
ZIP/Postal Code
04025-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18156921
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.
Results Reference
background
PubMed Identifier
11807353
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.
Results Reference
background
PubMed Identifier
15545560
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.
Results Reference
background
PubMed Identifier
18235928
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.
Results Reference
result
Links:
URL
http://www.umm.edu/general_surgery/nissen_fundo.htm
Description
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Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

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