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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872755
First Posted: March 31, 2009
Last Update Posted: March 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
G. Hatzikosta General Hospital
  Purpose
Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.

Condition Intervention Phase
Gastroesophageal Reflux Disease Hiatal Hernia Barrett's Esophagus Esophagitis Dysphagia Procedure: Nissen Procedure: Gastropexy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by G. Hatzikosta General Hospital:

Primary Outcome Measures:
  • Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD [ Time Frame: 9-94 months postoperatively ]

Enrollment: 90
Study Start Date: January 2002
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nissen
Laparoscopic Nissen Fundoplication
Procedure: Nissen
Laparoscopic Nissen Fundoplication
Active Comparator: Gastropexy
Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy
Procedure: Nissen
Laparoscopic Nissen Fundoplication
Procedure: Gastropexy
posterior gastropexy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Indications for surgical treatment of GERD
  • ASA I, II

Exclusion Criteria:

  • ASA III, IV
  • Previous gastric procedures
  • Conversion to open procedure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872755


Locations
Greece
G. Hatzikosta General Hospital Department of Surgery
Ioannina, Epirus, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
Investigators
Study Chair: Evangelos C. Tsimoyiannis, M.D. chairman G. Hatzikosta General Hospital, Ioannina, Greece
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evangelos C. Tsimoyiannis, G. Hatzikosta General Hospital, Ioannina, Greece
ClinicalTrials.gov Identifier: NCT00872755     History of Changes
Other Study ID Numbers: GH-1948-02
GHDS-12345-2
First Submitted: March 30, 2009
First Posted: March 31, 2009
Last Update Posted: March 31, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Barrett Esophagus
Hernia, Hiatal
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Digestive System Abnormalities
Hernia, Diaphragmatic
Hernia
Pathological Conditions, Anatomical