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

Paraesophageal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606449
• Other study ID #: UniBoDipTrap2
• Secondary ID: II-IV HH
• Status: Completed
• Phase: N/A
• First received: May 23, 2012
• Last updated: May 24, 2012
• Start date: January 1980
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease With Hiatal Hernia
• Hernia
• Hernia, Hiatal
• Paraesophageal Hernia

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of General Surgery and Organ Transplantation	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

External Links

•   Department of General Surgery and Organ Transplantation