Barrett's Esophagus, Dysphagia, Esophagitis, Gastroesophageal Reflux Disease, Hiatal Hernia
Conditions
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.
Interventions
PROCEDURENissen
Laparoscopic Nissen Fundoplication
PROCEDUREGastropexy
posterior gastropexy
Sponsors
G. Hatzikosta General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD | 9-94 months postoperatively |
Countries
Greece
Outcome results
None listed