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

NCT01606449 | Completed

• 2 other identifiers: UniBoDipTrap2II-IV HH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease With Hiatal Hernia; Paraesophageal Hernia

Keywords

Gastroesophageal reflux diseases; Hiatal Hernia; Paraesophageal Hernia

Study Arms (3)

Group 1

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

Procedure: Surgical Therapy

Group 2

Group 2 = Patients with type III Hiatal Hernia submitted to surgical therapy

Procedure: Surgical Therapy

Group 3

Group 3 = Patients with type IV Hiatal Hernia submitted to surgical therapy

Procedure: Surgical Therapy

Interventions

Surgical Therapy 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 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Department of General Surgery and Organ Transplantation

Bologna, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 26377635 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandro Mattioli, MD

  Department of General Surgery and Organ Transplantations

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor M.D.

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: January 1, 1980
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 25, 2012

Record last verified: 2012-01

Locations

IT (1)