Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandro Mattioli, University of Bologna
ClinicalTrials.gov Identifier:
NCT01606449
First received: May 23, 2012
Last updated: May 24, 2012
Last verified: January 2012
  Purpose

Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. The real recurrence rates and the results of surgery for GERD are difficult to assess due to the lack of serial time points during the follow-up. Further bias may have been introduced into the analysis by a lack of appropriate controls. The results of surgical therapy for type II-IV HH are even more controversial because of the high rate of anatomical relapse and the different methods of follow-up adopted in reported case series.

Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The investigators report on patients who were followed up after surgery at various time points over the course of 30 years.


Condition Intervention
Gastroesophageal Reflux Disease With Hiatal Hernia
Paraesophageal Hernia
Procedure: Surgical Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Thirty-year Follow-up of a Case Series of Patients Operated Upon for Type II-IV Hiatal Hernia

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Enrollment: 100
Study Start Date: January 1980
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Group 1 = Patients with type II Hiatal Hernia submitted to surgical therapy
Procedure: Surgical Therapy

Open Anti-reflux fundoplication according to Nissen-Rossetti, floppy Nissen, Belsey MK IV,Collis Nissen, Collis-Belsey.

Minimally-Invasive fundoplication according to floppy Nissen, left thoracoscopic Collis-laparoscopic Nissen.

Group 2
Group 2 = Patients with type III Hiatal Hernia submitted to surgical therapy
Procedure: Surgical Therapy

Open Anti-reflux fundoplication according to Nissen-Rossetti, floppy Nissen, Belsey MK IV,Collis Nissen, Collis-Belsey.

Minimally-Invasive fundoplication according to floppy Nissen, left thoracoscopic Collis-laparoscopic Nissen.

Group 3
Group 3 = Patients with type IV Hiatal Hernia submitted to surgical therapy
Procedure: Surgical Therapy

Open Anti-reflux fundoplication according to Nissen-Rossetti, floppy Nissen, Belsey MK IV,Collis Nissen, Collis-Belsey.

Minimally-Invasive fundoplication according to floppy Nissen, left thoracoscopic Collis-laparoscopic Nissen.


Detailed Description:

We reviewed the charts of patients who underwent primary surgery for type II-IV Hiatal Hernia during the period from January 1980 - December 2010.

Pre-operatively, the patients routinely underwent symptom assessment, a barium swallow, upper GI endoscopy and esophageal manometry.

The principles of surgery for GERD and hiatal hernias involve full isolation of the diaphragmatic pillars and E-G junction, full isolation and resection of the sac and fat pad into the mediastinum (except for the fat close to the lesser curvature, to preserve the integrity of the vagus nerves), evaluation of the degree of esophageal shortening, and a Collis gastroplasty in cases of short esophagi.

Post-operatively, the patients participated in a free-of-charge outpatient follow-up program at 6 months, 12 months and every year for 5 years.

The length of the follow-up was calculated from the day of the surgery to the day that the patient underwent the last complete follow-up. The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (from 0 = absence of symptoms and esophagitis to 3 = severe symptoms and esophagitis). An evaluation scale for the surgical results, with scores ranging from "excellent" to "poor", was also used.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients consecutively operated upon for type II-IV hiatal hernia in the period January 1980-December 2010.

Criteria

Inclusion Criteria:

  • patients aged > 18 years, undergoing surgery for the treatment of type II-IV hiatal hernia ± GERD.

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: NCT01606449

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

Additional Information:
No publications provided

Responsible Party: Sandro Mattioli, Associate Professor M.D., University of Bologna
ClinicalTrials.gov Identifier: NCT01606449     History of Changes
Other Study ID Numbers: UniBoDipTrap2, II-IV HH
Study First Received: May 23, 2012
Last Updated: May 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
Gastroesophageal reflux diseases
Hiatal Hernia
Paraesophageal Hernia

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 September 16, 2014