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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT00872755
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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 Blind (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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided by G. Hatzikosta General Hospital

Additional 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
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on November 27, 2014