Hernia, Inguinal
Conditions
Brief summary
Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.
Detailed description
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.
Interventions
DEVICELiquiBandFix8
Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
Sponsors
St John of God Hospital, Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Inguinal hernia, * femoral hernia
Exclusion criteria
* pregnancy, * not able to understand patient information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | During hospitalization and 6 weeks after surgery. | 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. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Inguinal Herniation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Region of Enrollment Austria | 34 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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.
Time frame: During hospitalization and 6 weeks after surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-port TAPP Repair | 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. | 6 participants |