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

NCT ID: NCT01606449

Last Updated: 2012-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1980-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Gastroesophageal Reflux Disease With Hiatal Hernia; Paraesophageal Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

Group 1 = Patients with type II Hiatal Hernia submitted to surgical therapy

Surgical Therapy

Intervention Type: PROCEDURE

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

Surgical Therapy

Intervention Type: PROCEDURE

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

Surgical Therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Sandro Mattioli

Associate Professor M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandro Mattioli, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Surgery and Organ Transplantations

Locations

Department of General Surgery and Organ Transplantation

Bologna, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 26377635 (View on PubMed)

Other Identifiers

II-IV HH

Identifier Type: REGISTRY

Identifier Source: secondary_id

UniBoDipTrap2

Identifier Type: -

Identifier Source: org_study_id