Incisional Hernia of Anterior Abdominal WallNCT04512469
Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients
A study testing Low molecular weight mesh in people with Incisional Hernia of Anterior Abdominal Wall, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Study Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation. Study procedures: Consenting patients will be divided into two matched groups: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia of Anterior Abdominal Wall
- What is being tested?
- Low molecular weight mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients above 18 years of age undergoing liver transplantation
Who cannot join
- Non consenting patients
- patients with skin or deep tissue infections at the time of surgery
- prior mesh infection from hernia repair will be excluded
- entry into the gastro-intestinal system (i.e., need for hepaticojejunostomy for transplantation versus just a standard biliary-biliary anastomosis)
- prior biliary stent (causes colonization of the biliary track and increases surgical site infection)
- patients that are unstable, requiring pressors, or required >4 units of packed red blood cell transfusions intra-operatively will be excluded as to not prolong surgical time.
Show all 14Show fewer
- Pregnant women
- Prior incisional hernia/history of IH and repair
- Death within 1-year
- Insufficient follow up
- Connective tissue disorders
- Prior significant wound dehiscence or infection
- Spontaneous bacterial peritonitis
- Primary sclerosing cholangitis (requires roux en y reconstruction thereby entry into the Alimentary track)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Examining the Efficacy of Prophylactic on Lay Mesh Versus Standardized Fascial Closure on Ventral Incisional Hernia Rates in Liver Transplant Patients
Study Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation.
Study procedures: Consenting patients will be divided into two matched groups:
Read more
- CONTROL group - receiving a standard running fascial closure with PDS suture
- TREATMENT group - receiving a standard running fascial closure with PDS suture PLUS a low molecular weight mesh. The mesh will be secured to the fascia extending 3 cm from the incisional site.
There will be no modifications to routine post-operative wound care in both groups. However, the treatment group will have an additional drain placed at the incision site compared to the control group to reduce the risk of a seroma from placement of the mesh. Wound dressing will be removed on post-op day 2 and the wound will be assessed. Re-application of the dressing will occur thereafter until proper healing of the incision.
An abdominal ultrasound will be done on all study participants at the 1- and 2-year mark postoperatively to look for objective evidence of a ventral incisional hernia. A CT scan will be performed if the abdominal ultrasound findings are inconclusive.
Read the detailed description
An incisional hernia is a common complication of abdominal surgery with an incidence of 4-20%. Liver transplant patients represent a unique cohort of surgical patients with immediate immune suppression post-operatively. It is presumed that this immune suppression accompanied by significant co-morbidities have led to high incisional ventral hernia rates between 4.9%-34.3%.
A recent 2018 retrospective review of 1044 liver transplant patients identified age >55, high BMI > 25, and immediate rejection were significant risk factors contributing to herniation. However, previously concerning considerations including gender, diagnosis, diabetes, Child-Pugh score, MELD score, donor type, hepato-renal syndrome, varix bleeding, ascites, hepatic encephalopathy, ventilator use, spontaneous bacterial peritonitis (SBP), or bile leak were not identified as significant risk factors. Moreover, the mortality for chronic liver disease patients for elective hernia repair is 3.7% at 90 days and morbidity is 27%. Emergent hernia repair led to 10% 90-day mortality with 60% morbidity. The high incidence of herniation represents a common problem with significant morbidity and mortality post liver transplantation thereby requiring investigating a new preventative solution.
A recent retrospective trial in the colorectal literature identified an institutional incidence of incisional hernia for colorectal patients of 39.9%. They recognized two high-risk populations, obese, and non-obese with a combination of several secondary risk factors. A follow-up prospective cohort study separated all colorectal patients undergoing laparotomy to standardized running PDS closure versus those with BMI>29 (the median in the prior study) and those BMI <29 with >=2 risk factors to include standard closure with an on-lay Ultrapro partially absorb-able mesh covering 3 cm adjacent to the incision placed with double down facial staples followed by a subcutaneous drain. The reported risk factors included BMI, smoking, serum creatinine, hemoglobin, serum albumin, COPD diabetes, immune suppression with steroids or radiation/chemotherapy, and previous midline laparotomy. The results revealed a decrease in the incisional hernia rate from 43.9% to 10% (P=0.0001). This study also concluded the treatment was cost effective and safe.
- Being tested
- Low molecular weight mesh
- Keywords
- liver transplant, incisional hernia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight meshDevice
Following liver implantation, the subcostal incision will be closed using a running fascial closure with absorbable 1-0 Polydioxanone (PDS) suture and staples, with the treatment group also receiving a mesh.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will undergo standard running fascial closure with PDS . |
| Treatment Group - Mesh | Experimental | The treatment group will undergo standard running fascial closure with PDS plus a low molecular weight mesh extending 3 cm from the fascial incision. Receives: Device: Low molecular weight mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incisional hernia post-operatively
The primary outcome will be incisional hernia rate at 1 year post-operatively.
Measured: 1 year
Secondary outcomes (2)
Rate of incisional hernia post-operatively
Incisional hernia rates at post-operative year 2
Measured: 2 years
Rate of surgical complications
Assess rate of surgical complications as per Clavien Dindo classification
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Incisional Hernia of Anterior Abdominal WallStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research coordinators will identify patients diagnosed with end-stage liver disease who are candidates for liver transplantation for study eligibility (see inclusion and exclusion criteria). Participants will be randomly selected to be included in one of two groups: the control or treatment group. The control group will undergo standard running fascial closure with PDS while the treatment group will undergo this closure plus a low molecular weight mesh extending 3 cm from the fascial incision. There will be no alteration to this standard of care schedule for this clinical trial. Data will be collected at every 12-month intervals to rule out clinical evidence of a hernia. The presence of a hernia will be assessed via clinical examination and abdominal ultrasound imaging. If findings from the abdominal ultrasound are inconclusive, a non-contrast CT scan will be performed. The study will end when either the primary or secondary outcomes are reached.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Sponsor
- Investigators
- Anton Skaro, MD, Principal investigator, Associate Professor - Surgery, Schulich School of Medicine & Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512469
- Sponsor's protocol ID
- Hernia Mesh Liver Transplant
- Status last verified
- Dec 2019
- First submitted
- 7 Jul 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Argudo N, Pera M, Lopez-Cano M, Hernandez L, Sancho JJ, Grande L, Pereira JA. Selective Mesh Augmentation to Prevent Incisional Hernias in Open Colorectal Surgery Is Safe and Cost-Effective. Front Surg. 2018 Feb 16;5:8. doi: 10.3389/fsurg.2018.00008. eCollection 2018. No abstract available.
PubMed 29503821Bachir NM, Larson AM. Adult liver transplantation in the United States. Am J Med Sci. 2012 Jun;343(6):462-9. doi: 10.1097/MAJ.0b013e3182308b66.
PubMed 22683615Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major laparotomies. Br Med J (Clin Res Ed). 1982 Mar 27;284(6320):931-3. doi: 10.1136/bmj.284.6320.931.
PubMed 6279229Israelsson LA, Jonsson T. Incisional hernia after midline laparotomy: a prospective study. Eur J Surg. 1996 Feb;162(2):125-9.
PubMed 8639725Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg. 1985 Jan;72(1):70-1. doi: 10.1002/bjs.1800720127.
PubMed 3155634Pereira JA, Pera M, Grande L. [Incidence of incisional hernia after open and laparoscopic colorectal cancer resection]. Cir Esp. 2013 Jan;91(1):44-9. doi: 10.1016/j.ciresp.2012.05.004. Epub 2012 Jul 4. Spanish.
PubMed 22769029Piazzese E, Montalti R, Beltempo P, Bertelli R, Puviani L, Pacile V, Nardo B, Cavallari A. Incidence, predisposing factors, and results of surgical treatment of incisional hernia after orthotopic liver transplantation. Transplant Proc. 2004 Dec;36(10):3097-8. doi: 10.1016/j.transproceed.2004.10.047.
PubMed 15686704Vardanian AJ, Farmer DG, Ghobrial RM, Busuttil RW, Hiatt JR. Incisional hernia after liver transplantation. J Am Coll Surg. 2006 Oct;203(4):421-5. doi: 10.1016/j.jamcollsurg.2006.06.017. Epub 2006 Aug 17.
PubMed 17000384
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Examining the Efficacy of Prophylactic on Lay Mesh Versus Standardized Fascial Closure on Ventral Incisional Hernia Rates in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT04512469
- Acronym / sponsor ID
- Hernia Mesh Liver Transplant
- Keywords
- liver transplant, incisional hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation.
Study procedures: Consenting patients will be divided into two matched groups:
- CONTROL group - receiving a standard running fascial closure with PDS suture
- TREATMENT group - receiving a standard running fascial closure with PDS suture PLUS a low molecular weight mesh. The mesh will be secured to the fascia extending 3 cm from the incisional site.
There will be no modifications to routine post-operative wound care in both groups. However, the treatment group will have an additional drain placed at the incision site compared to the control group to reduce the risk of a seroma from placement of the mesh. Wound dressing will be removed on post-op day 2 and the wound will be assessed. Re-application of the dressing will occur thereafter until proper healing of the incision.
An abdominal ultrasound will be done on all study participants at the 1- and 2-year mark postoperatively to look for objective evidence of a ventral incisional hernia. A CT scan will be performed if the abdominal ultrasound findings are inconclusive.
Detailed description
An incisional hernia is a common complication of abdominal surgery with an incidence of 4-20%. Liver transplant patients represent a unique cohort of surgical patients with immediate immune suppression post-operatively. It is presumed that this immune suppression accompanied by significant co-morbidities have led to high incisional ventral hernia rates between 4.9%-34.3%.
A recent 2018 retrospective review of 1044 liver transplant patients identified age >55, high BMI > 25, and immediate rejection were significant risk factors contributing to herniation. However, previously concerning considerations including gender, diagnosis, diabetes, Child-Pugh score, MELD score, donor type, hepato-renal syndrome, varix bleeding, ascites, hepatic encephalopathy, ventilator use, spontaneous bacterial peritonitis (SBP), or bile leak were not identified as significant risk factors. Moreover, the mortality for chronic liver disease patients for elective hernia repair is 3.7% at 90 days and morbidity is 27%. Emergent hernia repair led to 10% 90-day mortality with 60% morbidity. The high incidence of herniation represents a common problem with significant morbidity and mortality post liver transplantation thereby requiring investigating a new preventative solution.
A recent retrospective trial in the colorectal literature identified an institutional incidence of incisional hernia for colorectal patients of 39.9%. They recognized two high-risk populations, obese, and non-obese with a combination of several secondary risk factors. A follow-up prospective cohort study separated all colorectal patients undergoing laparotomy to standardized running PDS closure versus those with BMI>29 (the median in the prior study) and those BMI <29 with >=2 risk factors to include standard closure with an on-lay Ultrapro partially absorb-able mesh covering 3 cm adjacent to the incision placed with double down facial staples followed by a subcutaneous drain. The reported risk factors included BMI, smoking, serum creatinine, hemoglobin, serum albumin, COPD diabetes, immune suppression with steroids or radiation/chemotherapy, and previous midline laparotomy. The results revealed a decrease in the incisional hernia rate from 43.9% to 10% (P=0.0001). This study also concluded the treatment was cost effective and safe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research coordinators will identify patients diagnosed with end-stage liver disease who are candidates for liver transplantation for study eligibility (see inclusion and exclusion criteria). Participants will be randomly selected to be included in one of two groups: the control or treatment group. The control group will undergo standard running fascial closure with PDS while the treatment group will undergo this closure plus a low molecular weight mesh extending 3 cm from the fascial incision. There will be no alteration to this standard of care schedule for this clinical trial. Data will be collected at every 12-month intervals to rule out clinical evidence of a hernia. The presence of a hernia will be assessed via clinical examination and abdominal ultrasound imaging. If findings from the abdominal ultrasound are inconclusive, a non-contrast CT scan will be performed. The study will end when either the primary or secondary outcomes are reached.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will undergo standard running fascial closure with PDS . |
| Treatment Group - Mesh | Experimental | Device: Low molecular weight meshThe treatment group will undergo standard running fascial closure with PDS plus a low molecular weight mesh extending 3 cm from the fascial incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients above 18 years of age undergoing liver transplantation
Key exclusion criteria (14 listed)
- Non consenting patients
- patients with skin or deep tissue infections at the time of surgery
- prior mesh infection from hernia repair will be excluded
- entry into the gastro-intestinal system (i.e., need for hepaticojejunostomy for transplantation versus just a standard biliary-biliary anastomosis)
- prior biliary stent (causes colonization of the biliary track and increases surgical site infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight meshFollowing liver implantation, the subcostal incision will be closed using a running fascial closure with absorbable 1-0 Polydioxanone (PDS) suture and staples, with the treatment group also receiving a mesh. | Device | Treatment Group - Mesh |
Primary outcome
Rate of incisional hernia post-operatively
Time frame: 1 year
The primary outcome will be incisional hernia rate at 1 year post-operatively.
2 secondary outcomes
Rate of incisional hernia post-operatively
Time frame: 2 years
Rate of surgical complications
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Results publication: PubMed 29503821Argudo N, Pera M, Lopez-Cano M, Hernandez L, Sancho JJ, Grande L, Pereira JA. Selective Mesh Augmentation to Prevent Incisional Hernias in Open Colorectal Surgery Is Safe and Cost-Effective. Front Surg. 2018 Feb 16;5:8. doi: 10.3389/fsurg.2018.00008. eCollection 2018. No abstract available.
- Results publication: PubMed 22683615Bachir NM, Larson AM. Adult liver transplantation in the United States. Am J Med Sci. 2012 Jun;343(6):462-9. doi: 10.1097/MAJ.0b013e3182308b66.
- Results publication: PubMed 6279229Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major laparotomies. Br Med J (Clin Res Ed). 1982 Mar 27;284(6320):931-3. doi: 10.1136/bmj.284.6320.931.
- Results publication: PubMed 8639725Israelsson LA, Jonsson T. Incisional hernia after midline laparotomy: a prospective study. Eur J Surg. 1996 Feb;162(2):125-9.
- Results publication: PubMed 3155634Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg. 1985 Jan;72(1):70-1. doi: 10.1002/bjs.1800720127.
- Results publication: PubMed 22769029Pereira JA, Pera M, Grande L. [Incidence of incisional hernia after open and laparoscopic colorectal cancer resection]. Cir Esp. 2013 Jan;91(1):44-9. doi: 10.1016/j.ciresp.2012.05.004. Epub 2012 Jul 4. Spanish.
- Results publication: PubMed 15686704Piazzese E, Montalti R, Beltempo P, Bertelli R, Puviani L, Pacile V, Nardo B, Cavallari A. Incidence, predisposing factors, and results of surgical treatment of incisional hernia after orthotopic liver transplantation. Transplant Proc. 2004 Dec;36(10):3097-8. doi: 10.1016/j.transproceed.2004.10.047.
- Results publication: PubMed 17000384Vardanian AJ, Farmer DG, Ghobrial RM, Busuttil RW, Hiatt JR. Incisional hernia after liver transplantation. J Am Coll Surg. 2006 Oct;203(4):421-5. doi: 10.1016/j.jamcollsurg.2006.06.017. Epub 2006 Aug 17.
- Individual participant dataSharing planned: No
Related trials for Incisional Hernia of Anterior Abdominal Wall
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Skaro, MD principal investigator
Associate Professor - Surgery, Schulich School of Medicine & Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Low molecular weight mesh in people with Incisional Hernia of Anterior Abdominal Wall, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Jada, MD (416-388-9421, george.jada@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of incisional hernia post-operatively (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512469, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.