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

NCT00852098 | Completed DMC

• 1 other identifier: 1069/06
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastroesophageal Reflux

Keywords

Fundoplication; gastroesophageal reflux; gastric vessels; surgery

Outcome Measures

Primary Outcomes (1)

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

  two years

Secondary Outcomes (1)

• Long-term clinical and endoscopic outcome

  8-10 years

Study Arms (2)

1

ACTIVE COMPARATOR

dividing short gastric vessels

Procedure: Lap Nissen fundoplication with division of short gastric vessels

2

ACTIVE COMPARATOR

non-dividing short gastric vessels

Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels

Interventions

Lap Nissen fundoplication with division of short gastric vessels PROCEDURE

Dividing short gastric vessels

Also known as: Fundoplication, Gastroesophageal Reflux,Surgery

1

Laparoscopic Nissen fundoplication without division of short gastric vessels PROCEDURE

non-dividing short gastric vessels

Also known as: Fundoplication, Gastroesophageal Reflux,Surgery

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• objective gastroesophageal reflux in adults

You may not qualify if:

• esophageal motility disorder
• hard stenosis
• previous antireflux surgery

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Hospital State Public: collaborator

Study Sites (2)

Federal University of São Paulo - UNIFESP

São Paulo, São Paulo, 04023-071, Brazil

Location

State Public Server of São Paulo Hospital (HSPE)

São Paulo, São Paulo, 04025-000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 18156921 BACKGROUND

• 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.

  PMID: 11807353 BACKGROUND

• 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.

  PMID: 15545560 BACKGROUND

• 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.

  PMID: 18235928 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Study Officials

• José Carlos DelGrande, MD

  Federal University of São Paulo

  STUDY DIRECTOR

• Michelle L DeOliveira, MD

  Federal University of São Paulo

  STUDY CHAIR

• Francisco Farah, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Renato Lupinacci, MD

  Hospital State Public Server São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: November 1, 1997
• Primary Completion: January 1, 2000
• Study Completion: May 1, 2008
• Last Updated: February 26, 2009

Record last verified: 2009-02

Locations

BR (2)