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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

Primary Purpose

Gastroesophageal Reflux Disease, Hiatal Hernia, Barrett's Esophagus

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Nissen
Gastropexy
Sponsored by
G. Hatzikosta General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • G. Hatzikosta General Hospital Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nissen

Gastropexy

Arm Description

Laparoscopic Nissen Fundoplication

Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy

Outcomes

Primary Outcome Measures

Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD

Secondary Outcome Measures

Full Information

First Posted
March 30, 2009
Last Updated
March 30, 2009
Sponsor
G. Hatzikosta General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00872755
Brief Title
Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)
Official Title
Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
G. Hatzikosta General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Hiatal Hernia, Barrett's Esophagus, Esophagitis, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nissen
Arm Type
Active Comparator
Arm Description
Laparoscopic Nissen Fundoplication
Arm Title
Gastropexy
Arm Type
Active Comparator
Arm Description
Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy
Intervention Type
Procedure
Intervention Name(s)
Nissen
Intervention Description
Laparoscopic Nissen Fundoplication
Intervention Type
Procedure
Intervention Name(s)
Gastropexy
Intervention Description
posterior gastropexy
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelos C. Tsimoyiannis, M.D. chairman
Organizational Affiliation
G. Hatzikosta General Hospital, Ioannina, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
G. Hatzikosta General Hospital Department of Surgery
City
Ioannina
State/Province
Epirus
ZIP/Postal Code
45001
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
19960205
Citation
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.
Results Reference
derived

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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

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