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

NCT01606449 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2012-05-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Sandro Mattioli, MD · Department of General Surgery and Organ Transplantations

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1980-01-31
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606449 on ClinicalTrials.gov