Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study. A Multicenter Prospective, Consecutive Case Series Study, on the Use of a Bio-absorbable Mesh for Prevention of Incisional Hernia, in High Risk Patients, After Orthotopic Liver Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of incisional hernias after LT
研究概览
简要总结
A multicenter prospective, consecutive case series study, on the use of a bio-absorbable mesh for prevention of incisional hernia, in high risk patients, after orthotopic liver transplantation.
详细描述
STUDY DESIGN Multicenter, prospective, consecutive case series study.
OBJECTIVE The main purpose of the study is to determine whether a bio-absorbable mesh is effective and safe in the prevention of incisional hernia in high risk patients undergoing LT.
Primary endpoint:
• To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.
Secondary endpoint:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Have at least 3 of the following pre transplant risk factors for IH (definition of high Risk Patients):
- •Obesity (HR 1.74, 1.04 to 2.91) (16) (BMI equal to or higher than 30 kg/m², according WHO definition)
- •Smoker (OR 3.93, 1.82 to 8.49) (14). An adult who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day, according WHO definition.
- •Diabetes (OR 6.68, 2.02 to 22.0) (14) as defined by Centers of Disease Control and Prevention):
- •Result A1C Test Fasting Blood Sugar Test Glucose Tolerance Test Random Blood Sugar Test Diabetes 6.5% or above 126 mg/dL or above 200 mg/dL or above 200 mg/dL or above
- •IRC according KDIGO definition: "CKD is defined as abnormalities of kidney structure or function, present for >3 months, with implications for health," and requires one of two criteria documented or inferred for >3 months: either GFR <60 ml/min/1.73 m2 or markers of kidney damage, including albuminuria.
- •MELD > 22 (16)
- •COPD (HR 2.35, 1.44 to 3.83) (16): previous diagnosis of emphysema, chronic bronchitis, and chronic obstructive asthma. In pulmonary function testing, a postbronchodilator FEV1/FVC ratio of <0.70 is commonly considered diagnostic for COPD according The Global Initiative for Chronic Obstructive Lung Disease (GOLD) system.
- •Moderate/Large ascites at time of transplant. The International Ascites Club classifies the severity classification of ascites as follows: moderate ascites (grade 2): moderate abdominal distention, large ascites (grade 3): marked abdominal distention.
- •Sarcopenia (if diagnosed with CT-scan or RM). The study of the muscular compartment at the level of the third lumbar vertebra (L3) by CT is the gold standard technique in the assessment of sarcopenia. (10) The sum of the areas of psoas, erector spinae, multifidus, quadratus lomborum, rectus of the abdomen, transverse and internal and external obliques are divided by the squared height of the patient and define the skeletal muscle index: SMI (Skeletal Muscle Index) = SMA (Skeletal Muscle Area) (cm²) / height (m²). Sarcopenia is defined by cut-off values below 41,6 cm²/m² for men and 32 cm²/m² for women.
排除标准
- •- retransplant, previous upper quadrants laparotomies, previous incisional hernia repair, umbilical hernia > 2cm in diameter, pre-Tx steroids treatment or immunosuppression, patient's rejection to participate.
结局指标
主要结局
Incidence of incisional hernias after LT
时间窗: 2 years follow up
To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.
次要结局
- Incidence of IH in different type of incisions, Incidence od SSO(2 years follow up)
研究者
Alessandro Anselmo
Prof.
University of Rome Tor Vergata