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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

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

March 30, 2009
March 31, 2009
March 31, 2009
January 2002
April 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)
Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Hiatal Hernia
  • Barrett's Esophagus
  • Esophagitis
  • Dysphagia
  • Procedure: Nissen
    Laparoscopic Nissen Fundoplication
  • Procedure: Gastropexy
    posterior gastropexy
  • Active Comparator: Nissen
    Laparoscopic Nissen Fundoplication
    Intervention: Procedure: Nissen
  • Active Comparator: Gastropexy
    Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy
    Interventions:
    • Procedure: Nissen
    • Procedure: Gastropexy
Tsimogiannis KE, Pappas-Gogos GK, Benetatos N, Tsironis D, Farantos C, Tsimoyiannis EC. Laparoscopic Nissen fundoplication combined with posterior gastropexy in surgical treatment of GERD. Surg Endosc. 2010 Jun;24(6):1303-9. doi: 10.1007/s00464-009-0764-0. Epub 2009 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00872755
GH-1948-02
GHDS-12345-2
No
Not Provided
Not Provided
Evangelos C. Tsimoyiannis, G. Hatzikosta General Hospital, Ioannina, Greece
G. Hatzikosta General Hospital
Not Provided
Study Chair: Evangelos C. Tsimoyiannis, M.D. chairman G. Hatzikosta General Hospital, Ioannina, Greece
G. Hatzikosta General Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP