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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProGrip™ mesh repair | Active Comparator | Laparoscopic hiatal hernia repair with ProGrip™ mesh |
|
| Primary crural repair | Active Comparator | Primary posterior crura repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic hiatal hernia repair with ProGrip™ mesh | Procedure | Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate of hiatal hernia | Recurrence of hiatal hernia will be assessed by barium contrast swallow study | 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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|
| Laparoscopic primary posterior crural repair | Procedure | Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |