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

This study has been completed.
Sponsor:
Collaborator:
Hospital State Public
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00852098
First received: February 25, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux
Procedure: Lap Nissen fundoplication with division of short gastric vessels
Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels. [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term clinical and endoscopic outcome [ Time Frame: 8-10 years ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: November 1997
Study Completion Date: May 2008
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
dividing short gastric vessels
Procedure: Lap Nissen fundoplication with division of short gastric vessels
Dividing short gastric vessels
Other Name: Fundoplication, Gastroesophageal Reflux,Surgery
Active Comparator: 2
non-dividing short gastric vessels
Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels
non-dividing short gastric vessels
Other Name: Fundoplication, Gastroesophageal Reflux,Surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • objective gastroesophageal reflux in adults

Exclusion Criteria:

  • esophageal motility disorder
  • hard stenosis
  • previous antireflux surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852098

Locations
Brazil
Federal University of São Paulo - UNIFESP
São Paulo, Brazil, 04023-071
State Public Server of São Paulo Hospital (HSPE)
São Paulo, Brazil, 04025-000
Sponsors and Collaborators
Federal University of São Paulo
Hospital State Public
Investigators
Study Director: José Carlos DelGrande, MD Federal University of São Paulo
Study Chair: Michelle L DeOliveira, MD Federal University of São Paulo
Principal Investigator: Francisco Farah, MD Federal University of São Paulo
Study Chair: Renato Lupinacci, MD Hospital State Public Server São Paulo
  More Information

Additional Information:
Publications:
Responsible Party: JOSÉ FRANCISCO DE MATTOS FARAH, FEDERAL UNIVERSITY OF SÃO PAULO
ClinicalTrials.gov Identifier: NCT00852098     History of Changes
Other Study ID Numbers: 1069/06
Study First Received: February 25, 2009
Last Updated: February 25, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Fundoplication
gastroesophageal reflux
gastric vessels
surgery

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014