Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroesophageal Reflux Disease Barrett Esophagus Barrett's Esophagus Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Esophageal Motility Disorders Esophagitis Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Neoplasms Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Precancerous Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

G. Hatzikosta General Hospital Department of Surgery

Ioannina, Epirus, 45001, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nissen

Procedure

Laparoscopic Nissen Fundoplication

Gastropexy

Procedure

posterior gastropexy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

G. Hatzikosta General Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2008
Study completion: 2008
First posted: Mar 31, 2009
Registry last updated: Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed