Clinical Trial: Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication

Brief Summary: Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.

Detailed Summary:
Sponsor: PD Dr. Urs Zingg

Current Primary Outcome: Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan [ Time Frame: minimum 1 year after surgery ]

To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: minimum 1 year after surgery ]
    Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery
  • Clinical outcome [ Time Frame: minimum 1 year after surgery ]
    Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.
  • Peri- and postoperative morbidity / mortality [ Time Frame: minimum 1 year after surgery ]
    Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination


Original Secondary Outcome: Same as current

Information By: Spital Limmattal Schlieren

Dates:
Date Received: January 9, 2017
Date Started: January 2016
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017