Trial Outcomes & Findings for Review of Complex Recurrent Hernia Repair (NCT NCT01644695)
NCT ID: NCT01644695
Last Updated: 2012-10-15
Results Overview
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
Recruitment status
UNKNOWN
Target enrollment
85 participants
Primary outcome timeframe
ongoing, average 2.4 years
Results posted on
2012-10-15
Participant Flow
Participant milestones
| Measure |
Candidate for BARS Procedure.
The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to
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|---|---|
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Overall Study
STARTED
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85
|
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Overall Study
COMPLETED
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85
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Review of Complex Recurrent Hernia Repair
Baseline characteristics by cohort
| Measure |
Candidate for BARS Procedure.
n=85 Participants
The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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85 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age Continuous
|
53.25 years
STANDARD_DEVIATION 10.22 • n=5 Participants
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Sex: Female, Male
Female
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72 Participants
n=5 Participants
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
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Region of Enrollment
United States
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85 participants
n=5 Participants
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PRIMARY outcome
Timeframe: ongoing, average 2.4 yearsPopulation: Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation.
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
Outcome measures
| Measure |
Candidate for BARS Procedure.
n=85 Participants
The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to
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|---|---|
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Recurrence Rate
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3 participants
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SECONDARY outcome
Timeframe: ongoing, average 2.4 yearsPopulation: There were 6 instances of wound dehiscence. There were 2 instances each of infection, necrosis, DVT,hematoma, and neuroma. There was 1 instance each of cellulitis, bowel obstruction, entrapped nerve, and temporary numbness. Further surgery was required 7 times, of which 3 included partial removal of the mesh. 27 complications in total.
Record of intra and post operative complications resulting from BARS(bony anchoring reinforcement system) procedure including but not limited to scarring, pain, numbness, intra-abdominal injury, bleeding, death, infection, anesthesia complications, and need for further surgery.
Outcome measures
| Measure |
Candidate for BARS Procedure.
n=85 Participants
The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.
Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to
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|---|---|
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Intra and Post-Operative Complications
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27 participants
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Adverse Events
All Participants
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=85 participants at risk
No participant was excempt from this measure.
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|---|---|
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Skin and subcutaneous tissue disorders
Wound Dehiscence
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7.1%
6/85 • Number of events 6 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Infections and infestations
Infection
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2.4%
2/85 • Number of events 2 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Musculoskeletal and connective tissue disorders
Necrosis
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2.4%
2/85 • Number of events 2 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Skin and subcutaneous tissue disorders
Hematoma
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2.4%
2/85 • Number of events 2 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Skin and subcutaneous tissue disorders
Cellulitis
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1.2%
1/85 • Number of events 1 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Blood and lymphatic system disorders
DVT
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2.4%
2/85 • Number of events 2 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Gastrointestinal disorders
Bowel obstruction
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1.2%
1/85 • Number of events 1 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Nervous system disorders
Neuroma
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2.4%
2/85 • Number of events 2 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Injury, poisoning and procedural complications
Infected Mesh
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3.5%
3/85 • Number of events 3 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Injury, poisoning and procedural complications
Drain Issue
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2.4%
2/85 • Number of events 2 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Nervous system disorders
Entrapped Nerve
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1.2%
1/85 • Number of events 1 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Nervous system disorders
Neuralgia Paresthetica
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1.2%
1/85 • Number of events 1 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Injury, poisoning and procedural complications
Further Surgery Required
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8.2%
7/85 • Number of events 7 • Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
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Additional Information
Dr. Andrew Elkwood, MD
Institute For Advanced Reconstruction
Phone: 732-741-0970
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place