Ventral Incisional Hernia
Conditions
Keywords
Complex ventral incisional hernia repair, reapproximation of the rectus abdominis muscle, retrorectus or intraperitoneal placement technique, mobility for midline fascial closure
Brief summary
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.
Detailed description
The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%.
Interventions
DEVICEGORE® BIO-A® Tissue Reinforcement
Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects will be informed about the study, and will have read; understood and signed the informed consent and authorization to use their PHI, as applicable * Subjects willing and able to submit to postoperative follow-up evaluations including quality of life assessments up to 24 months after surgery * Subjects of either gender that are at least the age of 18 years * Subjects will have a Body-Mass Index (BMI) of \< 40 * Subjects will be undergoing single-staged open complex ventral incisional hernia repair with the retrorectus or intraperitoneal placement technique of the GORE® BIO-A® Tissue Reinforcement * Subjects in which intraoperatively their surgical field/wound is characterized either a Type 2 or Type 3 in Table 1 in Section 12.0 * Subjects with a hernia defect \> 9 cm2 large when measured intraoperatively * Subjects in which the required mobility for midline fascial closure without excessive tension to reapproximate the rectus abdominis muscle intraoperatively can be achieved * Subjects in which one unit of GORE® BIO-A® Tissue Reinforcement will adequately reinforce the midline fascial closure with at least 4 cm of overlap laterally
Exclusion criteria
* Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study * Subjects with a BMI \> 40 * Subjects with evidence of pre-existing systemic infections * Subjects with cirrhosis or are currently being treated with dialysis * Subjects with a wound-healing disorder * Subjects with autoimmune disorder requiring \> 10mg of a corticosteroid per day * Subjects who are immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy * Subjects with a hernia defect \< 9 cm2 large when measured intraoperatively * Subjects with a hernia defect requiring more than one unit of GORE® BIO-A® Tissue Reinforcement * Subjects in which intraoperatively there is an inability to achieve retrorectus or intraperitoneal placement of the device * Subjects in which a midline fascial closure without excessive tension cannot be achieved * Subjects in which intraoperatively their surgical field/wound is characterized either a Type 1 or Type 4 in the Table 1 in Section 12 * Subjects in need of concomitant surgical procedures other than indicated in the protocol as acceptable * Subject in which their complex ventral incisional hernia repair requires more than one operation to reduce hernia and close fascia, including serial excision procedures - requiring subsequent surgery to complete their hernia repair * Subjects with a hernia repair requiring an emergent procedure, such as strangulated bowel * Subjects in which intraoperatively untreated cancer was found
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence Rate | at about 24 months | Investigator confirmed hernia recurrence by physical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early and Long-term Complication Rates | after surgery (day 1) to 24 months | Surgical site abdominal wound event rate |
Countries
Netherlands, United States
Participant flow
Recruitment details
104 subjects recruited from 9 sites in the US and Netherlands between March 2011 and December 2012
Participants by arm
| Arm | Count |
|---|---|
| Single-staged Open Complex Ventral Incisional Hernia Repair primary or recurrent anterior abdominal wall hernia
GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure | 104 |
| Total | 104 |
Baseline characteristics
| Characteristic | Single-staged Open Complex Ventral Incisional Hernia Repair |
|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 13.4 |
| BMI (Body Mass Index) | 27.6 kg/m^2 STANDARD_DEVIATION 6.1 |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 42 Participants |
| Wound Classification Clean-contaminated | 24 participants |
| Wound Classification Contaminated | 80 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 104 |
| serious Total, serious adverse events | 3 / 104 |
Outcome results
Primary
Hernia Recurrence Rate
Investigator confirmed hernia recurrence by physical examination
Time frame: at about 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-staged Open Complex Ventral Incisional Hernia Repair | Hernia Recurrence Rate | 17.3 % of subjects with recurrent hernia |
Secondary
Early and Long-term Complication Rates
Surgical site abdominal wound event rate
Time frame: after surgery (day 1) to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-staged Open Complex Ventral Incisional Hernia Repair | Early and Long-term Complication Rates | 29.8 % of subjects with events |