Foreshortened Esophagus and Its Surgical Therapy (GERDSurgery)
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|ClinicalTrials.gov Identifier: NCT00507377|
Recruitment Status : Unknown
Verified July 2007 by University of Bologna.
Recruitment status was: Active, not recruiting
First Posted : July 26, 2007
Last Update Posted : July 26, 2007
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.
|Condition or disease|
|Gastroesophageal Reflux Disease Hiatal Hernia|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Frequency, Predictors, Intraoperative Assessment and Outcome of Foreshortened Esophagus and Its Surgical Therapy in Patients Treated for Gastro-Esophageal Reflux Disease (GERD)|
|Study Start Date :||September 2005|
|Estimated Study Completion Date :||July 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507377
|Dept. of "Surgery, Intensive Care and Organs Transplantation"|
|Bologna, Italy, 40138|
|Department of General and Minimally Invasive Surgery -- Esophago-gastric Surgery Unit, Istituto Clinico Humanitas, Rozzano, University of Milan|
|Milan, Italy, 20089|
|First Division of General and Gastrointestinal Surgery, Second University of Naples|
|Naples, Italy, 80131|
|Unit of Gastrointestinal Surgery, School of Medicine, II University of Naples|
|Naples, Italy, 80135|
|VIII Division of General Surgery and Gastroenterologic Physiopathology, II University of Naples|
|Naples, Italy, 80138|
|Department of Medical and Surgical Sciences Clinica Chirurgica 3, University of Padova|
|Padua, Italy, 35128|
|General Surgery IV, Regional Referral Center for Esophageal Pathology, Department of Medical and Surgical Gastroenterology, AOU Pisana, Pisa|
|Pisa, Italy, 56126|
|Department of Surgery, Minimally Invasive Surgery Center, University of Turin|
|Turin, Italy, 10126|
|Study Chair:||Sandro Mattioli, MD||University of Bologna|