Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change from baseline red blood cells (RBC)
研究概览
简要总结
The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.
详细描述
After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Primary Hip Arthroplasty
- •Lateral Hardinge Approach
- •Non-cemented Acetabular and Femoral Components
- •Length of Skin Incision between 10 and 20 cm
排除标准
- •Coagulative Disorders
- •Previous Surgery in the same limb
- •Age below 18 years old
结局指标
主要结局
Change from baseline red blood cells (RBC)
时间窗: Pre-operative and 24 Hours Postoperative
total RBC loss (mL) = \[Uncompensated RBC loss (mL)\] + \[Compensated RBC loss (mL)\] Uncompensated RBC loss (mL) = \[Initial RBC (mL)\] - \[Final RBC (mL)\] Compensated RBC loss (mL) = \[Sum of RBCs received from the various sources of transfusion\] Initial RBC (mL) = \[Estimated blood volume (mL)\] x \[Initial Hct level (%)\] at Day -1 Final RBC (mL) = \[Estimated blood volume (mL)\] x \[Final Hct level (%)\] at Day +3 Estimated blood volume (mL) = Women: \[Body surface area (m2)\] x 2430 Men: \[Body surface area (m2)\] x 2530 Body surface area (m2) = 0.0235 x \[Height (cm)\]0.42246 x \[Weight (kg)\]0.51456 Total blood loss at Hct level of 35% (mL) = \[Total blood loss (mL)\] / 0.35
次要结局
- Erythrocyte sedimentation rate (ESR) (mm/h)(3,6 and 12 Weeks Postoperative)
- C-Reactive Protein (CRP) (mg/L)(3,6 and 12 Weeks Postoperative)
- Mid thigh circumference (cm)(Pre-operative and 24 Hours Postoperative to 3 Months Postoperative)
- Complications(during 3 months follow-up)
研究者
Jose Ricardo Negreiros Vicente
Head of Hip Surgery Group
University of Sao Paulo