Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

Study Overview
=================
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.

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

Conditions
-----------------
Hiatal Hernia Large

Intervention / Treatment
-----------------
* Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient cohort<br>Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication | Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | minimum 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | minimum 1 year after surgery |