Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients

NCT04512469 | Not Yet Recruiting FDA Device

• 1 other identifier: Hernia Mesh Liver Transplant
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.CONTROL group - receiving a standard running fascial closure with PDS suture
2. 2.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.

Conditions

Incisional Hernia of Anterior Abdominal Wall

Keywords

liver transplant; incisional hernia

Outcome Measures

Primary Outcomes (1)

• Rate of incisional hernia post-operatively

  The primary outcome will be incisional hernia rate at 1 year post-operatively.

  1 year

Secondary Outcomes (2)

• Rate of incisional hernia post-operatively

  2 years

• Rate of surgical complications

  2 years

Study Arms (2)

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.

Device: Low molecular weight mesh

Interventions

Low molecular weight mesh DEVICE

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.

Treatment Group - Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients above 18 years of age undergoing liver transplantation

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ethicon, Inc.: collaborator

Related Publications (8)

• 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.

  PMID: 29503821 RESULT

• Bachir 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.

  PMID: 22683615 RESULT

• Bucknall 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.

  PMID: 6279229 RESULT

• Israelsson LA, Jonsson T. Incisional hernia after midline laparotomy: a prospective study. Eur J Surg. 1996 Feb;162(2):125-9.

  PMID: 8639725 RESULT

• Mudge 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.

  PMID: 3155634 RESULT

• Pereira 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.

  PMID: 22769029 RESULT

• Piazzese 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.

  PMID: 15686704 RESULT

• Vardanian 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.

  PMID: 17000384 RESULT

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Anton Skaro, MD

  Associate Professor - Surgery, Schulich School of Medicine & Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Jada, MD

CONTACT

416-388-9421; george.jada@lhsc.on.ca

Anton Skaro, MD

CONTACT

519-663-2904; Anton.Skaro@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 13, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share