Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

G. Hatzikosta General Hospital

Status and phase: Completed; Phase 4

Conditions: Esophagitis; Dysphagia; Hiatal Hernia; Gastroesophageal Reflux Disease; Barrett's Esophagus

Treatments: Procedure: Gastropexy; Procedure: Nissen

Study type: Interventional

Funder types: Other

Identifiers

NCT00872755

GH-1948-02

GHDS-12345-2

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Nissen

Active Comparator group

Description:

Laparoscopic Nissen Fundoplication

Treatment:

Procedure: Nissen

Gastropexy

Active Comparator group

Description:

Procedure/Surgery Laparoscopic Nissen Fundoplication combined with posterior gastropexy

Treatment:

Procedure: Nissen

Procedure: Gastropexy