Approach to Hiatal Hernia Repair Based on Collagen Study

Study Overview
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Brief Summary
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Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.

Detailed Description
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The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or cruroraphy with mesh reinforcement techniques. Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after surgery. Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia recurrence rate but associated with a large number of mesh-related complications.

Official Title
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Approach to Hiatal Hernia Repair Based on Collagen Study

Conditions
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Hiatal Hernia, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh
* Procedure: Laparoscopic primary posterior crural repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 20 years Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity) Performance of laparoscopic hiatal hernia repair Informed Consent as documented by signature Exclusion Criteria: Cases of conversion to open surgery Age < 20 years and > 80 years History of oesophageal/gastric/duodenal surgery including vagotomy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ProGrip™ mesh repair<br>Laparoscopic hiatal hernia repair with ProGrip™ mesh | Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh<br>* Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh<br>* Other names: Laparoscopic mesh hiatal closure;|
| Active Comparator: Primary crural repair<br>Primary posterior crura repair | Procedure: Laparoscopic primary posterior crural repair<br>* Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures<br>* Other names: Laparoscopic posterior crural closure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of hiatal hernia | Recurrence of hiatal hernia will be assessed by barium contrast swallow study | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and satisfaction | Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life. | 36 months |