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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandro Mattioli, University of Bologna
ClinicalTrials.gov Identifier:
NCT01587859
First received: April 26, 2012
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  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 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 Intervention
Paraesophageal Hernia
 Procedure: laparoscopic surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Frequency of True Short Esophagus in Type II-IV Hiatus Hernia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Global Results [ Time Frame: minimum 12 months ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 34
Study Start Date: January 1995
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort
Patients submitted to laparoscopic surgery for Type II-IV hiatus hernia
 Procedure: laparoscopic surgery
Nissen fundoplication; Collis Gastroplasty.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Department of general Surgery and Organ Transplantation  This link exits the ClinicalTrials.gov site

No publications provided by University of Bologna

Additional 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
Study First Received: April 26, 2012
Last Updated: April 27, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by 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
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013