Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease; Hiatal Hernia; Barrett's Esophagus; Esophagitis; Dysphagia
• Interventions: Procedure: Nissen; Procedure: Gastropexy

• Registration Number: NCT00872755
• Lead Sponsor: G. Hatzikosta General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2008-04
• Study Completion: 2008-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Last Update Submitted: 2009-03-30
• Study First Posted: 2009-03-31
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nissen	Nissen	Laparoscopic Nissen Fundoplication
Gastropexy	Nissen	Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy
Gastropexy	Gastropexy	Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy

Primary Outcome Measures

Name	Time	Method
Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD	9-94 months postoperatively

Trial Locations

Locations (1)

G. Hatzikosta General Hospital Department of Surgery; 🇬🇷 Ioannina, Epirus, Greece