Clinical trial NCT01355939: Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Adhesions
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
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: Atrium Medical Corporation
First posted: 2011-05-19
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators' patient population

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mesh adhesiolysis time:Mesh surface area
timeFrame: Intraoperatively (day 1)
Secondary outcomes:
measure: Mesh Contracture
timeFrame: Intraoperatively (day 1)
measure: Mesh adhesion tenacity
timeFrame: Intraoperatively (day 1)
measure: Percentage mesh surface area covered with adhesions
timeFrame: Intraoperatively (day 1)
measure: Adhesiolysis time to abdominal wall
timeFrame: Intraoperatively (day 1)
measure: Adhesiolysis time to mesh
timeFrame: Intraoperatively (day 1)
measure: Incidence of adhesiolysis-related intra-operative complications
timeFrame: Intraoperatively (day 1)
measure: Length of stay of hospital admission
timeFrame: 30 day postoperative
measure: Length of stay in ICU
timeFrame: 30 day postoperative
measure: Interval to return to bowel function
timeFrame: 30 day postoperative
measure: Interval to return to independent ambulation or activities of daily living
timeFrame: 30 day postoperative
measure: Interval to return to work or routine physical activity
timeFrame: 30 day postoperative
measure: Incidence of postoperative complications
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Incidence of surgical site infection
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Incidence of initiation of antibiotics, blood and total parenteral nutrition
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Incidence of bedside procedures to address a postoperative surgical complication
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Incidence of surgery under local anesthesia to address a postoperative complication
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Incidence of single system organ failure
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Incidence of multiple-system organ failure
timeFrame: 30 day, 12 month, and 24 month postoperative
measure: Mortality rate
timeFrame: 30 day, 12 month, and 24 month postoperative
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: San Diego
country: United States
facility: University of California-San Diego
state: California
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Greenville
country: United States
facility: Greenville Medical Center
state: South Carolina
Study officials:
affiliation: Washington University School of Medicine
name: Michael Brunt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: