Short Esophagus in Type II-IV Hiatus Hernia

NCT01587859 | Completed

• 1 other identifier: UniboDipTrap
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Paraesophageal Hernia

Keywords

esophagus; gastro-esophageal reflux disease; type II-IV hiatal hernia; esophageal surgery; minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• Global Results

  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.

  minimum 12 months

Study Arms (1)

Cohort

Patients submitted to laparoscopic surgery for Type II-IV hiatus hernia

Procedure: laparoscopic surgery

Interventions

laparoscopic surgery PROCEDURE

Nissen fundoplication; Collis Gastroplasty.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (2)

Department of Surgery and Organ Transplantation

Bologna, BO, 40138, Italy

Location

Sandro Mattioli

Bologna, BO, 40138, Italy

Location

Related Publications (1)

• Lugaresi M, Mattioli S, Aramini B, D'Ovidio F, Di Simone MP, Perrone O. The frequency of true short oesophagus in type II-IV hiatal hernia. Eur J Cardiothorac Surg. 2013 Feb;43(2):e30-6. doi: 10.1093/ejcts/ezs602. Epub 2012 Nov 27.

  PMID: 23186837 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Secretary

  Departement of General Surgery and Organ Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: January 1, 1995
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

IT (2)