Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rijnstate Vriendenfonds | UNKNOWN |
Not provided
Not provided
Not provided
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-absorbable sutures | Active Comparator | The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures |
|
| Non-absorbable sutures and a TiMESH® | Active Comparator | The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures and a TiMESH® to reinforce the repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh repair | Device | Augmentation of hiatal hernia repair with TiMESH® reinforcement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of objective recurrence of a hiatal hernia | Objective measurement of the integrity of the hiatal hernia repair by CT-imaging | 5-10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of clinical recurrence of a hiatal hernia | Recurrence of symptoms related to a hiatal hernia measured by a questionnaire | 5-10 years |
| Symptoms of gastroesophageal reflux disease | Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Bouwmeester, MSc | Contact | 088 - 005 8888 | obouwmeester@rijnstate.nl |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
randomised controlled trial
Not provided
Not provided
Patients were blinded for repair with sutures alone or sutures with mesh augmentation
| Suture repair | Procedure | Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures |
|
| 5-10 years |
| Patient satisfaction | Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'. | 5-10 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |