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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ventral Hernia, Adhesions

Intervention / Treatment
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* Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abdominal surgery after prior VHR with barrier-coated mesh<br> | Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery<br>* 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.<br>* Other names: CollaMend(TM);|
| Abdominal surgery after prior VHR with nonbarrier-coated mesh<br> | Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery<br>* 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.<br>* Other names: CollaMend(TM);|
| Lap adhesiolysis during abdominal surgery after prior VHR<br> | Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery<br>* 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.<br>* Other names: CollaMend(TM);|
| Open adhesioloysis during abdominal surgery after prior VHR<br> | Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery<br>* 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.<br>* Other names: CollaMend(TM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh adhesiolysis time:Mesh surface area |  | Intraoperatively (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Incidence of adhesiolysis-related intra-operative complications |  | Intraoperatively (day 1) | 
| Length of stay of hospital admission |  | 30 day postoperative | 
| Length of stay in ICU |  | 30 day postoperative | 
| Interval to return to bowel function |  | 30 day postoperative | 
| Interval to return to independent ambulation or activities of daily living |  | 30 day postoperative | 
| Interval to return to work or routine physical activity |  | 30 day postoperative | 
| Incidence of postoperative complications |  | 30 day, 12 month, and 24 month postoperative | 
| Incidence of surgical site infection |  | 30 day, 12 month, and 24 month postoperative | 
| Incidence of initiation of antibiotics, blood and total parenteral nutrition |  | 30 day, 12 month, and 24 month postoperative | 
| Incidence of bedside procedures to address a postoperative surgical complication |  | 30 day, 12 month, and 24 month postoperative | 
| Incidence of surgery under local anesthesia to address a postoperative complication |  | 30 day, 12 month, and 24 month postoperative | 
| Incidence of single system organ failure |  | 30 day, 12 month, and 24 month postoperative | 
| Incidence of multiple-system organ failure |  | 30 day, 12 month, and 24 month postoperative | 
| Mortality rate |  | 30 day, 12 month, and 24 month postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Approach, Hernia, Adhesiolysis, Adhesions, Intraperitoneal Mesh, Abdominal Re-exploration, Mesh, Barrier-Coated Mesh, Non-Barrier-Coated Mesh, Laparoscopic Approach, Abdominal Re-Exploration Surgery