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NCT00872755 Clinical Trial

Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

Dysphagia Clinical Trial

Official title:
Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00872755
Other study ID # GH-1948-02
Secondary ID GHDS-12345-2
Status Completed
Phase Phase 4
First received March 30, 2009
Last updated March 30, 2009
Start date January 2002
Est. completion date December 2008

Study information
Verified date March 2009
Source G. Hatzikosta General Hospital
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Nissen
Laparoscopic Nissen Fundoplication
• Gastropexy
posterior gastropexy

Locations
Country Name City State
Greece G. Hatzikosta General Hospital Department of Surgery Ioannina Epirus

Sponsors (1)
Lead Sponsor Collaborator
G. Hatzikosta General Hospital

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD 9-94 months postoperatively Yes
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