Gastroesophageal Reflux Disease Clinical Trial
— GERDSurgeryOfficial title:
Frequency, Predictors, Intraoperative Assessment and Outcome of Foreshortened Esophagus and Its Surgical Therapy in Patients Treated for Gastro-Esophageal Reflux Disease (GERD)
NCT number | NCT00507377 |
Other study ID # | 61657 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2005 |
Est. completion date | July 2007 |
Verified date | May 2018 |
Source | University of Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background The existence, diagnosis and treatment of short esophagus is one of the
controversies of the past which has recently re-emerged The missed diagnosis of short
esophagus and the consequent inadequacy of treatment is one of the major causes of failure of
antireflux surgery.
The daily clinical practice of surgeons dedicated to therapy of esophageal diseases could
take advantage of the definition of frequency, preoperative predictors, intraoperative
management and post operative outcomes of cases of foreshortened esophagus, in order to offer
the patient affected by GERD the elements necessary for a conscious choice of therapy and to
plan the best performance of the surgical procedure.
Aims of the Study To define the percentage of cases among the total of antireflux procedures
performed, in which, after standard isolation of the ge junction and eventual dissection of
the mediastinal esophagus at least two centimetres of esophagus can not be replaced without
any applied tension below the apex of the diaphragmatic hiatus.
To define the percentage of surgical procedures aimed to treat electively a condition of non
reducible G-E junction and foreshortened esophagus, among a multicentric formed case series
of patients submitted to antireflux surgery.
To define the preoperative clinical and instrumental predictors for a surgical procedure
aimed to treat foreshortened esophagus.
To record the intra-operative, postoperative, 6 month and 12 month outcome of procedures
adopted for the surgical treatment of GERD.
Materials and Methods The study will comprise patients in which surgical therapy for GERD is
indicated according to the international guidelines and the Centres policy .
Patients will be submitted to the antireflux procedure chosen by the surgeon according to the
internationally recognized scientific surgical principles and the personal judgement.
The preoperative study and the postoperative follow up adopted in the present study are
accepted by the Centres as they correspond to the international guidelines and the Centres'
current practice criteria for the surgical treatment of GERD.
Status | Completed |
Enrollment | 180 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients aged > 18 years, undergoing surgery for the treatment of GERD, of massive incarcerated hiatus hernia ± GERD, in which a laparotomic, laparoscopic or thoracotomic approach is preoperatively indicated. Exclusion Criteria: - association of GERD with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders; - redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach, on the diaphragm. |
Country | Name | City | State |
---|---|---|---|
Italy | Dept. of "Surgery, Intensive Care and Organs Transplantation" | Bologna | |
Italy | Department of General and Minimally Invasive Surgery -- Esophago-gastric Surgery Unit, Istituto Clinico Humanitas, Rozzano, University of Milan | Milan | |
Italy | First Division of General and Gastrointestinal Surgery, Second University of Naples | Naples | |
Italy | Unit of Gastrointestinal Surgery, School of Medicine, II University of Naples | Naples | |
Italy | VIII Division of General Surgery and Gastroenterologic Physiopathology, II University of Naples | Naples | |
Italy | Department of Medical and Surgical Sciences Clinica Chirurgica 3, University of Padova | Padua | |
Italy | General Surgery IV, Regional Referral Center for Esophageal Pathology, Department of Medical and Surgical Gastroenterology, AOU Pisana, Pisa | Pisa | |
Italy | Department of Surgery, Minimally Invasive Surgery Center, University of Turin | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Bologna | The European Society of Esophagology |
Italy,
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