NCT01355939

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

3.7 years

First QC Date

April 26, 2011

Last Update Submit

February 19, 2015

Conditions

Ventral HerniaAdhesions

Keywords

HerniaAdhesiolysisAdhesionsIntraperitoneal MeshAbdominal Re-explorationMeshBarrier-Coated MeshNon-Barrier-Coated MeshLaparoscopic ApproachOpen ApproachAbdominal Re-Exploration Surgery

Outcome Measures

Primary Outcomes (1)

  • Mesh adhesiolysis time:Mesh surface area

    Intraoperatively (day 1)

Secondary Outcomes (19)

  • Mesh Contracture

    Intraoperatively (day 1)

  • Mesh adhesion tenacity

    Intraoperatively (day 1)

  • Percentage mesh surface area covered with adhesions

    Intraoperatively (day 1)

  • Adhesiolysis time to abdominal wall

    Intraoperatively (day 1)

  • Adhesiolysis time to mesh

    Intraoperatively (day 1)

  • +14 more secondary outcomes

Study Arms (4)

Abdominal surgery after prior VHR with barrier-coated mesh

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Abdominal surgery after prior VHR with nonbarrier-coated mesh

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Lap adhesiolysis during abdominal surgery after prior VHR

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Open adhesioloysis during abdominal surgery after prior VHR

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Interventions

Clinically-Indicated Abdominal Re-Exploration SurgeryPROCEDURE

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.

Also known as: 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)
Abdominal surgery after prior VHR with barrier-coated meshAbdominal surgery after prior VHR with nonbarrier-coated meshLap adhesiolysis during abdominal surgery after prior VHROpen adhesioloysis during abdominal surgery after prior VHR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Investigators' patient population

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mayo Clinic Scottsdale

Phoenix, Arizona, 85054, United States

Location

University of California-San Diego

San Diego, California, 92103, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Mount Sinai Medical Center

New York, New York, 10028, United States

Location

Greenville Medical Center

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Hernia, VentralTissue AdhesionsHernia

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCicatrixFibrosisPathologic Processes

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Michael Brunt, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

May 19, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations

US(6)