Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

N/AEnrolling By InvitationNCT03025932

Prof Urs Zingg200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Hiatal Hernia Large

Interventions

repair of giant hiatal hernia with mesh and anterior fundoplicationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age older than 18 years * Initially suffering from large hiatal hernia (\>20% of the stomach in the thoracic cavity) * Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication * Informed Consent as documented by signature (Appendix: Informed Consent Form) Exclusion Criteria: * Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication * Performance of anterior fundoplication without mesh * Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study

Outcomes

Primary Outcomes

Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan

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

Time frame: minimum 1 year after surgery

Secondary Outcomes

Quality of life by GIQLI

Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery

Time frame: minimum 1 year after surgery

Clinical outcome

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.

Time frame: minimum 1 year after surgery

Peri- and postoperative morbidity / mortality

Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination

Time frame: minimum 1 year after surgery

Data from ClinicalTrials.gov

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