Clinical trial NCT01606449: Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia
Official title: Thirty-year Follow-up of a Case Series of Patients Operated Upon for Type II-IV Hiatal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease With Hiatal Hernia
Paraesophageal Hernia
Keywords: Gastroesophageal reflux diseases
Hiatal Hernia
Paraesophageal Hernia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consecutively operated upon for type II-IV hiatal hernia in the period January 1980-December 2010.

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Department of General Surgery and Organ Transplantation
Study officials:
affiliation: Department of General Surgery and Organ Transplantations
name: Sandro Mattioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lugaresi M, Mattioli B, Daddi N, Di Simone MP, Perrone O, Mattioli S. Surgery for Type III-IV hiatal hernia: anatomical recurrence and global results after elective treatment of short oesophagus with open and minimally invasive surgery. Eur J Cardiothorac Surg. 2016 Apr;49(4):1137-43. doi: 10.1093/ejcts/ezv280. Epub 2015 Sep 16.