开放腹壁重建的手术前减肥:随机对照试验的研究方案
Daphne Remulla1, Kimberly S Miles2, Alvaro Carvalho2
1Department of Surgery, Cleveland Clinic Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, OH, USA. remulld@ccf.org.
概括
这项研究将前置手术与为期六个月的手术前医疗减肥计划进行比较,该计划适用于接受腹修复的严重肥胖患者. 结果将为在手术中管理肥胖的基于证据的指导方针提供信息.
科学领域:
- 手术瘤学手术瘤学
- 腹部外科 腹部外科
- 临床试验 临床试验
背景情况:
- 肥胖是一种已知的风险因素,导致腹修复的结果不佳.
- 目前的做法往往使用任意的BMI切割线 (35-40 kg/m2),限制获得护理.
- 这项研究解决了对严重肥胖 (BMI 40-55 kg/m2) 基于证据的指导方针的需求.
研究的目的:
- 为了比较前期手术的结果与手术前的医疗减肥结果,在接受腹修复的严重肥胖患者中.
- 为了评估前期手术与手术前的减肥相比,关于腹壁生活质量的非劣势.
- 评估二次结果,包括的复发,伤口发病率和患者报告的结果.
主要方法:
- 一个基于注册表的,并行的,随机的受控试验与1:1分配.
- 258名BMI为40-55kg/m2的患者被随机分配到6个月的手术前医疗减肥计划或预先开放的回肌腹修复.
- 主要结局:与相关的生活质量调查 (HerQLes) 一年后的总结分数.
主要成果:
- 主要假设:前置手术将在改善一年HerQLes分数方面与手术前减肥无差.
- 二次结果:的复发,伤口发病率,紧急修复,再入院,并发症和重新手术.
- 将分析患者报告的结果和与体重相关的变化.
结论:
- 手术前减肥可能会降低伤口发病率和技术困难,但会带来长期降低生活质量和紧急修复等风险.
- 这项试验将提供高质量的证据,以指导严重肥胖患者修复的临床实践.
- 结果将有助于建立基于证据的指导方针来管理这种患者群体.
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