Risk Factors for Mesh-Related Infection in Abdominal Wall Reconstruction: A Single-Centre Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Incidence of mesh-related infection within 90 days of abdominal wall reconstruction
研究概览
简要总结
Abdominal wall reconstruction (AWR) with mesh is the standard repair for ventral, incisional, parastomal and complex abdominal wall defects, but mesh-related infection remains one of its most serious complications - prolonging hospital stay, often requiring reoperation or removal of the mesh, and increasing the risk of hernia recurrence. Reported infection rates vary widely, and the independent contribution of individual risk factors remains uncertain, in large part because much of the existing evidence comes from retrospective series with inconsistent outcome definitions.
This single-centre, prospective observational cohort study will enrol consecutive adults undergoing elective or urgent AWR with synthetic, biosynthetic or biological mesh at a tertiary referral hernia unit. Participants will be followed for 12 months on a fixed schedule (7-10 days, 30 days, 90 days, 6 months and 12 months). Using internationally accepted, prespecified definitions of mesh infection and surgical site occurrence, the study will collect up to 18 candidate patient, defect, operative and perioperative risk factors and analyse them by multivariable logistic regression to identify the independent predictors of mesh-related infection within 90 days of surgery.
Secondary aims are to describe the incidence, timing, microbiology and management (salvage versus explantation) of mesh infection; to report surgical site occurrences and reoperation; and to derive an exploratory risk-stratification model. The findings are intended to support preoperative risk assessment, targeted patient optimisation, informed mesh and technique selection, and shared decision-making. The study is designed and reported in accordance with the STROBE statement.
详细描述
Design and setting. A prospective, single-centre observational cohort study conducted at a tertiary referral hernia and abdominal wall surgery unit (Department of Surgery, Faculty of Medicine, Minia University, Egypt). Consecutive eligible adults undergoing AWR with mesh are enrolled at the time of surgery and followed prospectively. No study-specific intervention is imposed; surgical and perioperative management follow routine unit practice, and exposures (candidate risk factors) are observed rather than assigned.
Study period. The study runs for 24 months in total, from 15 August 2026 to 15 August 2028. Consecutive enrolment takes place over the first 12 months (15 August 2026 - 15 August 2027); each participant is then followed for 12 months, so that the last enrolled participant completes follow-up at the end of month 24. The 90-day primary-outcome window closes for the final participant in November 2027.
Objectives. The primary objective is to identify the independent risk factors associated with mesh-related infection within 90 days of AWR. Secondary objectives are to estimate the cumulative incidence and timing of mesh infection; to characterise its microbiology and the proportion managed by mesh salvage versus partial or complete explantation; to describe surgical site occurrence (SSO) and SSO requiring procedural intervention (SSOPI); to derive an exploratory, prespecified risk-stratification model and assess its discrimination and calibration; and to evaluate the association of mesh infection with hernia recurrence and reoperation at 12 months.
Primary outcome. Mesh-related infection within 90 days, confirmed by at least one of: purulent drainage from a peri-mesh space in contact with the prosthesis; positive microbiological culture from peri-mesh fluid, explanted mesh or an image-guided/operative peri-mesh specimen; cross-sectional imaging (preferably contrast-enhanced CT) demonstrating a peri-mesh collection or abscess with clinical signs of infection; or the need for operative or percutaneous intervention directed at infected mesh. Superficial incisional infection without mesh involvement is recorded separately, and deep or organ/space infection is coded using CDC/NHSN criteria.
Candidate predictors. Up to 18 prespecified variables across four domains - patient (age, sex, BMI/obesity, active smoking, diabetes and HbA1c, serum albumin, ASA class, immunosuppression, COPD), defect (defect width by EHS grouping, recurrent hernia, loss of domain, CDC wound class, VHWG grade, stoma/parastomal defect), operative (mesh type and position, component separation including transversus abdominis release, operative time, concomitant bowel procedure, estimated blood loss, drain use) and perioperative (antibiotic-prophylaxis appropriateness, intraoperative normothermia and glycaemia, transfusion, early SSO).
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
- •Adults aged ≥18 years.
- •Undergoing elective or urgent abdominal wall reconstruction with implantation of synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect.
- •Able and willing to provide written informed consent and to attend scheduled follow-up.
排除标准
- •Suture-only repair without mesh.
- •Inguinal or femoral (groin) hernia repair.
- •Active systemic sepsis or established intra-abdominal mesh infection at the time of index surgery.
- •Mesh placed solely for a non-reconstructive indication (e.g. temporary abdominal closure or planned re-look without definitive reconstruction).
- •Estimated life expectancy < 12 months or inability to complete the minimum follow-up.
- •Patient declines participation.
研究组 & 干预措施
Abdominal wall reconstruction with mesh
Consecutive adults (≥18 years) undergoing elective or urgent abdominal wall reconstruction with synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect, enrolled at the time of surgery and followed prospectively for 12 months. No study-specific intervention is imposed; management follows routine unit practice.
结局指标
主要结局
Incidence of mesh-related infection within 90 days of abdominal wall reconstruction
时间窗: Within 90 days after surgery
Proportion of participants with mesh-related infection, defined as infection involving the implanted mesh confirmed by at least one of: purulent drainage from the wound or a peri-mesh space in contact with the prosthesis; positive microbiological culture from peri-mesh fluid, the explanted mesh, or an image-guided/operative peri-mesh specimen; cross-sectional imaging (preferably contrast-enhanced CT) demonstrating a peri-mesh collection or abscess with clinical signs of infection; or the need for operative or percutaneous intervention directed at infected mesh, including partial or complete explantation for infection.
次要结局
- Cumulative incidence and timing of mesh-related infection(Through 12 months after surgery)
- Microbiology of mesh-related infection(Through 12 months after surgery)
- Management of mesh infection: salvage versus explantation(Through 12 months after surgery)
- Incidence of surgical site occurrence (SSO)(30 days, 90 days and 12 months after surgery)
- Incidence of SSO requiring procedural intervention (SSOPI)(30 days, 90 days and 12 months after surgery)
- Incidence of surgical site infection(30 days after surgery)
- Incidence of hernia recurrence(12 months after surgery)
- Incidence of unplanned reoperation related to the index repair(12 months after surgery)
- Performance of the exploratory risk-stratification model(At completion of follow-up and analysis (up to 42 months))
研究者
Saleh Khairy Saleh MD
Lecturer of General Surgery, Department of Surgery, Faculty of Medicine
Minia University