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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

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.
 
ClinicalTrials.gov Identifier: NCT00872755
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : March 31, 2009
Sponsor:
Information provided by:
G. Hatzikosta General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Hiatal Hernia Barrett's Esophagus Esophagitis Dysphagia Procedure: Nissen Procedure: Gastropexy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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
Study Start Date : January 2002
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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
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Greece
G. Hatzikosta General Hospital Department of Surgery
Ioannina, Epirus, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
Investigators
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Study Chair: Evangelos C. Tsimoyiannis, M.D. chairman G. Hatzikosta General Hospital, Ioannina, Greece
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evangelos C. Tsimoyiannis, G. Hatzikosta General Hospital, Ioannina, Greece
ClinicalTrials.gov Identifier: NCT00872755    
Other Study ID Numbers: GH-1948-02
GHDS-12345-2
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Barrett Esophagus
Gastroesophageal Reflux
Esophagitis, Peptic
Esophagitis
Hernia, Hiatal
Hernia
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Precancerous Conditions
Neoplasms
Hernia, Diaphragmatic