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

May 24, 2012 updated by: Sandro Mattioli, University of Bologna

Thirty-year Follow-up of a Case Series of Patients Operated Upon for Type II-IV Hiatal Hernia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Department of General Surgery and Organ Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Sandro Mattioli, MD, Department of General Surgery and Organ Transplantations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1980

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

May 25, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniBoDipTrap2
  • II-IV HH (Registry Identifier: Type II-IV Hiatal Hernia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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