Ventral HerniaNCT01355939
Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh
An observational study of Ventral Hernia and Adhesions, run by Washington University School of Medicine at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Adhesions
- What is being tested?
- Clinically-Indicated Abdominal Re-Exploration Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 173 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2011to Jan 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Investigators' patient population
Who may be able to join
- 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
Who cannot join
- less than 18 years of age
- inability to verify intraperitoneal mesh type or location
- active abdominal wound infection or open abdominal wound
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Greenville Medical Center
Greenville, South Carolina, 29615
Mount Sinai Medical Center
New York, New York, 10028
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054
University of California-San Diego
San Diego, California, 92103
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University
St Louis, Missouri, 63110
About this study
Official 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
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.
Read more
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.
- Conditions
- Ventral Hernia, Adhesions
- Being tested
- Clinically-Indicated Abdominal Re-Exploration Surgery
- Keywords
- Hernia, Adhesiolysis, Adhesions, Intraperitoneal Mesh, Abdominal Re-exploration, Mesh, Barrier-Coated Mesh, Non-Barrier-Coated Mesh, Laparoscopic Approach, Open Approach, Abdominal Re-Exploration Surgery
- Medical subject headings
- Hernia, Ventral, Tissue Adhesions, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically-Indicated Abdominal Re-Exploration SurgeryProcedure or surgery
Also called Bard(TM) Mesh, PROLENE(TM), ProLite(TM), ProLite(TM) Ultra(TM)
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal surgery after prior VHR with barrier-coated mesh | Not described Receives: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery | |
| Abdominal surgery after prior VHR with nonbarrier-coated mesh | Not described Receives: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery | |
| Lap adhesiolysis during abdominal surgery after prior VHR | Not described Receives: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery | |
| Open adhesioloysis during abdominal surgery after prior VHR | Not described Receives: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesh adhesiolysis time:Mesh surface area
Measured: Intraoperatively (day 1)
Secondary outcomes (19)
Mesh Contracture
Measured: Intraoperatively (day 1)
Mesh adhesion tenacity
Measured: Intraoperatively (day 1)
Percentage mesh surface area covered with adhesions
Measured: Intraoperatively (day 1)
Adhesiolysis time to abdominal wall
Measured: Intraoperatively (day 1)
Adhesiolysis time to mesh
Measured: Intraoperatively (day 1)
Incidence of adhesiolysis-related intra-operative complications
Measured: Intraoperatively (day 1)
Length of stay of hospital admission
Measured: 30 day postoperative
Length of stay in ICU
Measured: 30 day postoperative
Interval to return to bowel function
Measured: 30 day postoperative
Interval to return to independent ambulation or activities of daily living
Measured: 30 day postoperative
Interval to return to work or routine physical activity
Measured: 30 day postoperative
Incidence of postoperative complications
Measured: 30 day, 12 month, and 24 month postoperative
Incidence of surgical site infection
Measured: 30 day, 12 month, and 24 month postoperative
Incidence of initiation of antibiotics, blood and total parenteral nutrition
Measured: 30 day, 12 month, and 24 month postoperative
Incidence of bedside procedures to address a postoperative surgical complication
Measured: 30 day, 12 month, and 24 month postoperative
Incidence of surgery under local anesthesia to address a postoperative complication
Measured: 30 day, 12 month, and 24 month postoperative
Incidence of single system organ failure
Measured: 30 day, 12 month, and 24 month postoperative
Incidence of multiple-system organ failure
Measured: 30 day, 12 month, and 24 month postoperative
Mortality rate
Measured: 30 day, 12 month, and 24 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Atrium Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Michael Brunt, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355939
- Sponsor's protocol ID
- 2011-02112
- Other IDs
- 1KM1CA156708-01
- Status last verified
- Feb 2015
- First submitted
- 26 Apr 2011
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01355939
- Acronym / sponsor ID
- 2011-02112
- Conditions
- Ventral Hernia, Adhesions
- Keywords
- Hernia, Adhesiolysis, Adhesions, Intraperitoneal Mesh, Abdominal Re-exploration, Mesh, Barrier-Coated Mesh, Non-Barrier-Coated Mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Atrium Medical Corporation
- Study start
- May 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 May 2011 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators' patient population
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- less than 18 years of age
- inability to verify intraperitoneal mesh type or location
- active abdominal wound infection or open abdominal wound
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 |
|---|---|---|
| Clinically-Indicated Abdominal Re-Exploration SurgeryAlso: Bard(TM) Mesh, PROLENE(TM), ProLite(TM), ProLite(TM) Ultra(TM)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. | Procedure or surgery | Abdominal surgery after prior VHR with barrier-coated mesh, Abdominal surgery after prior VHR with nonbarrier-coated mesh, Lap adhesiolysis during abdominal surgery after prior VHR, Open adhesioloysis during abdominal surgery after prior VHR |
Primary outcome
Mesh adhesiolysis time:Mesh surface area
Time frame: Intraoperatively (day 1)
19 secondary outcomes
Mesh Contracture
Time frame: Intraoperatively (day 1)
Mesh adhesion tenacity
Time frame: Intraoperatively (day 1)
Percentage mesh surface area covered with adhesions
Time frame: Intraoperatively (day 1)
Adhesiolysis time to abdominal wall
Time frame: Intraoperatively (day 1)
Adhesiolysis time to mesh
Time frame: Intraoperatively (day 1)
Incidence of adhesiolysis-related intra-operative complications
Time frame: Intraoperatively (day 1)
Length of stay of hospital admission
Time frame: 30 day postoperative
Length of stay in ICU
Time frame: 30 day postoperative
Interval to return to bowel function
Time frame: 30 day postoperative
Interval to return to independent ambulation or activities of daily living
Time frame: 30 day postoperative
Interval to return to work or routine physical activity
Time frame: 30 day postoperative
Incidence of postoperative complications
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of surgical site infection
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of initiation of antibiotics, blood and total parenteral nutrition
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of bedside procedures to address a postoperative surgical complication
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of surgery under local anesthesia to address a postoperative complication
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of single system organ failure
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of multiple-system organ failure
Time frame: 30 day, 12 month, and 24 month postoperative
Mortality rate
Time frame: 30 day, 12 month, and 24 month postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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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.
Michael Brunt, M.D. principal investigator
Washington University School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia and Adhesions, run by Washington University School of Medicine at 6 sites in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesh adhesiolysis time:Mesh surface area (time frame: Intraoperatively (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.