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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 6
- 主要终点
- Mesh adhesiolysis time:Mesh surface area
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •less than 18 years of age
- •inability to verify intraperitoneal mesh type or location
- •active abdominal wound infection or open abdominal wound
结局指标
主要结局
Mesh adhesiolysis time:Mesh surface area
时间窗: Intraoperatively (day 1)
次要结局
- Mesh Contracture(Intraoperatively (day 1))
- Adhesiolysis time to mesh(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))
- 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)