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Short Esophagus in Type II-IV Hiatus Hernia (SEHH)

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ClinicalTrials.gov Identifier: NCT01587859
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 for type II-IV hiatus hernia, in which, after standard isolation of the ge junction and 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.


Condition or disease Intervention/treatment
Paraesophageal Hernia Procedure: laparoscopic surgery

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Study Design

Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Frequency of True Short Esophagus in Type II-IV Hiatus Hernia
Study Start Date : January 1995
Primary Completion Date : December 2011
Study Completion Date : January 2012

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Cohort
Patients submitted to laparoscopic surgery for Type II-IV hiatus hernia
Procedure: laparoscopic surgery
Nissen fundoplication; Collis Gastroplasty.


Outcome Measures

Primary Outcome Measures :
  1. Global Results [ Time Frame: minimum 12 months ]

    Pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy and esophageal manometry.

    The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (form 0 = absence of symptoms or esophagitis, to 3 = severe symptoms and esophagitis.For the surgical results an evaluation scale , from "excellent" to "poor", was used.



Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients consecutively operated upon with minimally invasive surgery for type II-IV hiatus hernia in the period January 1995 - December 2010.
Criteria

Inclusion Criteria:

  • patients aged > 18 years, undergoing surgery for the treatment of type II-IV hiatus hernia ± GERD, in which a laparoscopic 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

Information from the National Library of Medicine

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): NCT01587859


Locations
Italy
Department of Surgery and Organ Transplantation
Bologna, BO, Italy, 40138
Sandro Mattioli
Bologna, BO, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
Principal Investigator: Secretary Departement of General Surgery and Organ Transplantation
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandro Mattioli, Associate Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT01587859     History of Changes
Other Study ID Numbers: UniboDipTrap
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Sandro Mattioli, University of Bologna:
esophagus
gastro-esophageal reflux disease
type II-IV hiatal hernia
esophageal surgery
minimally invasive surgery

Additional relevant MeSH terms:
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic