Incisional Ventral Hernia, Recurrent Ventral Hernia
Conditions
Keywords
ventral hernia, infection, hematoma, seroma, recurrence, mesh technique
Brief summary
Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an open intraperitoneal mesh technique.
Detailed description
We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.
Interventions
PROCEDUREmodified open mesh technique
We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
Sponsors
Varazdin General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged 18 years or older * American Society of Anesthesiologists physical status I, II, III
Exclusion criteria
* refusal of the patients to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma) | four weeks after the surgery | we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients With Postoperative Hernia Recurrence | up to 36 months after the surgery |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Modified Open Mesh Technique We performed an open intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
modified open mesh technique: We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh. | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | Modified Open Mesh Technique |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 62 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 12 |
| Region of Enrollment Croatia | 124 participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 124 |
| serious Total, serious adverse events | 0 / 124 |
Outcome results
Primary
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
Time frame: four weeks after the surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Modified Open Mesh Technique | Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma) | Infection | 9 participants |
| Modified Open Mesh Technique | Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma) | Seroma | 21 participants |
| Modified Open Mesh Technique | Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma) | Hematoma | 2 participants |
| Modified Open Mesh Technique | Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma) | No complications | 92 participants |
Secondary
Number of Patients With Postoperative Hernia Recurrence
Time frame: up to 36 months after the surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modified Open Mesh Technique | Number of Patients With Postoperative Hernia Recurrence | Reccurence with early complications | 7 Participants |
| Modified Open Mesh Technique | Number of Patients With Postoperative Hernia Recurrence | Reccurence with infection | 4 Participants |
| Modified Open Mesh Technique | Number of Patients With Postoperative Hernia Recurrence | No reccurence | 113 Participants |