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Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.
During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).
In addition, closure of peritoneum should be accomplished using this device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inguinal herniation | Experimental | In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquiBandFix8 | Device | Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively. | Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction. | During hospitalization and 6 weeks after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard DAUSER, MD | St John of God Hospital, Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St John of God Hospital | Graz | Styria | 8020 | Austria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inguinal Herniation | In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inguinal Herniation | In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively. | Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction. | Posted | Number | participants | During hospitalization and 6 weeks after surgery. |
|
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAPP Repair | LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| clogging of device | Surgical and medical procedures | Systematic Assessment | Malfunction of device by clogging of the tip was recorded. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernhard Dauser, MD, PhD | St John of God Hospital Vienna | +4321121 | 5098 | b.dauser@hotmail.com |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 34 |
| 6 |
| 34 |
|
| Persistent pain | Injury, poisoning and procedural complications | Non-systematic Assessment | Persistent pain in the groin following TAPP repair |
|
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