MedTrace Logo

Nissen and Gastroplasty in Gastroesophageal Reflux Disease (GERD)

NCT00872755 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2009-03-31

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease
  • Hiatal Hernia
  • Barrett's Esophagus
  • Esophagitis
  • Dysphagia

Interventions

PROCEDURE

Nissen

Laparoscopic Nissen Fundoplication

PROCEDURE

Gastropexy

posterior gastropexy

Sponsors & Collaborators

  • G. Hatzikosta General Hospital

    lead OTHER

Principal Investigators

  • Evangelos C. Tsimoyiannis, M.D. chairman · G. Hatzikosta General Hospital, Ioannina, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2008-04-30
Completion
2008-12-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872755 on ClinicalTrials.gov