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Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

NCT ID: NCT00872755

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease Hiatal Hernia Barrett's Esophagus Esophagitis Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Nissen

Laparoscopic Nissen Fundoplication

Group Type ACTIVE_COMPARATOR

Nissen

Intervention Type PROCEDURE

Laparoscopic Nissen Fundoplication

Gastropexy

Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy

Group Type ACTIVE_COMPARATOR

Nissen

Intervention Type PROCEDURE

Laparoscopic Nissen Fundoplication

Gastropexy

Intervention Type PROCEDURE

posterior gastropexy

Interventions

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Nissen

Laparoscopic Nissen Fundoplication

Intervention Type PROCEDURE

Gastropexy

posterior gastropexy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G. Hatzikosta General Hospital

OTHER

Sponsor Role lead

Responsible Party

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G. Hatzikosta General Hospital, Ioannina, Greece

Principal Investigators

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Evangelos C. Tsimoyiannis, M.D. chairman

Role: STUDY_CHAIR

G. Hatzikosta General Hospital, Ioannina, Greece

Locations

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G. Hatzikosta General Hospital Department of Surgery

Ioannina, Epirus, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 19960205 (View on PubMed)

Other Identifiers

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GHDS-12345-2

Identifier Type: -

Identifier Source: secondary_id

GH-1948-02

Identifier Type: -

Identifier Source: org_study_id