Gastroesophageal Reflux Disease, Hiatal Hernia
Conditions
Brief summary
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
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.
Interventions
PROCEDURELaparoscopic hiatal hernia repair with ProGrip™ mesh
Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
Sponsors
Grubnik Volodymyr
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of hiatal hernia | 36 months | Recurrence of hiatal hernia will be assessed by barium contrast swallow study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and satisfaction | 36 months | 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. |
Outcome results
None listed