Foreshortened Esophagus and Its Surgical Therapy (GERDSurgery)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University of Bologna.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The European Society of Esophagology
Fondazione Cassa di Risparmio di Bologna, Bologna, Italy
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00507377
First received: July 25, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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
Gastroesophageal Reflux Disease
Hiatal Hernia

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Frequency, Predictors, Intraoperative Assessment and Outcome of Foreshortened Esophagus and Its Surgical Therapy in Patients Treated for Gastro-Esophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Enrollment: 180
Study Start Date: September 2005
Estimated Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00507377

Locations
Italy
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
Unit of Gastrointestinal Surgery, School of Medicine, II University of Naples
Naples, Italy, 80135
First Division of General and Gastrointestinal Surgery, Second University of Naples
Naples, Italy, 80131
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
Sponsors and Collaborators
University of Bologna
The European Society of Esophagology
Fondazione Cassa di Risparmio di Bologna, Bologna, Italy
Investigators
Study Chair: Sandro Mattioli, MD University of Bologna
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00507377     History of Changes
Other Study ID Numbers: 61657
Study First Received: July 25, 2007
Last Updated: July 25, 2007
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
Esophageal Benign Disease
Gastroesophageal Reflux Disease
Hiatal Hernia
Antireflux Surgery
Short Esophagus

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia
Hernia, Hiatal
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on July 24, 2014