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NCT Number: NCT01355939

Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh

The proposed study will compare the benefits, harms, and comparative effectiveness of intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical circumstances. A subset of the data will be analyzed to compare the benefits, harms, and comparative effectiveness of the laparoscopic and open approaches to adhesiolysis. A comprehensive array of health-related risk factors and patient-centered outcomes will be assessed in the investigators diverse patient population for proper multivariate data analysis.

Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.

Specific Aim II: To evaluate and compare the adhesion-related complications and adhesiolysis-related complications of intraperitoneal barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.

Specific Aim III: To determine the comparative effectiveness of intraperitoneal barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations and clinical circumstances.

Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.

Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia repair.

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Key information

Conditions

Ventral Hernia Adhesions Cicatrix Fibrosis Hernia Hernia, Abdominal Hernia, Ventral Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Scottsdale, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • greater than or equal to 18 years of age
  • prior ventral hernia repair with intraperitoneal placement of mesh (open or laparoscopic approach; absorbable barrier-coated mesh, permanent barrier-coated composite mesh, permanent barrier-coated noncomposite mesh, non-barrier-coated polypropylene mesh, or biologic mesh)
  • subsequent abdominal procedure requiring exposure of entire surface area of intraperitoneal mesh

Exclusion criteria

  • less than 18 years of age
  • inability to verify intraperitoneal mesh type or location
  • active abdominal wound infection or open abdominal wound

Treatment and study plan

Clinically-Indicated Abdominal Re-Exploration Surgery

Procedure

This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.

Other names: Bard(TM) Mesh, PROLENE(TM), ProLite(TM), ProLite(TM) Ultra(TM), Bard(TM) Soft Mesh, PROLENE(TM) Soft, Parietex(TM) Flat Sheet TEC, INFINIT(TM) Mesh, C-QUR Lite(TM), ULTRAPRO(TM), PROLENE(TM) Hernia System, Bard(TM) Mesh PerFix Plug, Bard(TM) Ventralex, C-QUR(TM) Mesh, PROCEED(TM), Bard(TM) Sepramesh(TM) IP Composite, Parietex(TM) Composite, PHYSIOMESH(TM), Bard(TM) Composix(TM) E/X, Bard(TM) Composix(TM) L/P, DUALMESH(R), DUALMESH(R) Plus, VICRYL(TM), TIGR(R) Matrix, Gore (R) Bio-A(R), AlloDerm(R), AlloMax(TM), FlexHD(R), Biodesign(TM) Surgisis(R), Strattice(TM), XenMatrix(TM), Veritas(R), SurgiMend(R), Peri-Guard(R), Permacol(TM), CollaMend(TM) FM, CollaMend(TM)

Primary outcomes

  1. Mesh adhesiolysis time:Mesh surface area

    Time frame: Intraoperatively (day 1)

Secondary outcomes

  1. Mesh Contracture

    Time frame: Intraoperatively (day 1)

  2. Mesh adhesion tenacity

    Time frame: Intraoperatively (day 1)

  3. Percentage mesh surface area covered with adhesions

    Time frame: Intraoperatively (day 1)

  4. Adhesiolysis time to abdominal wall

    Time frame: Intraoperatively (day 1)

  5. Adhesiolysis time to mesh

    Time frame: Intraoperatively (day 1)

  6. Incidence of adhesiolysis-related intra-operative complications

    Time frame: Intraoperatively (day 1)

  7. Length of stay of hospital admission

    Time frame: 30 day postoperative

  8. Length of stay in ICU

    Time frame: 30 day postoperative

  9. Interval to return to bowel function

    Time frame: 30 day postoperative

  10. Interval to return to independent ambulation or activities of daily living

    Time frame: 30 day postoperative

  11. Interval to return to work or routine physical activity

    Time frame: 30 day postoperative

  12. Incidence of postoperative complications

    Time frame: 30 day, 12 month, and 24 month postoperative

  13. Incidence of surgical site infection

    Time frame: 30 day, 12 month, and 24 month postoperative

  14. Incidence of initiation of antibiotics, blood and total parenteral nutrition

    Time frame: 30 day, 12 month, and 24 month postoperative

  15. Incidence of bedside procedures to address a postoperative surgical complication

    Time frame: 30 day, 12 month, and 24 month postoperative

  16. Incidence of surgery under local anesthesia to address a postoperative complication

    Time frame: 30 day, 12 month, and 24 month postoperative

  17. Incidence of single system organ failure

    Time frame: 30 day, 12 month, and 24 month postoperative

  18. Incidence of multiple-system organ failure

    Time frame: 30 day, 12 month, and 24 month postoperative

  19. Mortality rate

    Time frame: 30 day, 12 month, and 24 month postoperative

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Atrium Medical Corporation
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Prospective Multicenter Trial to Evaluate Adhesion Characteristics and Adhesiolysis-related Complications of Barrier-coated and Non-barrier-coated Intraperitoneal Mesh During Abdominal Re-exploration After Prior Ventral Hernia Repair

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 19, 2011
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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