Damage Control Laparotomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number of Participants Who Died or Had Major Abdominal Complication (MAC)
研究概览
简要总结
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.
详细描述
Single center, prospective, randomized study involving seriously injure patients requiring an emergent laparotomy within 90 minutes of arrival to the emergency department. There are situations in which the patient is unable to be closed at the end of the emergent laparotomy (identified as damage control) and there are situations in which the injury has been treated and the incision can be closed (definitive). There are also situations where it is not clear if the patient should be kept open or closed and the result of the surgery varies based on the surgeon performing the case.
The eligible subjects for this study will be randomized toward the end of the emergent laparotomy procedure on a 1:1 basis and will be followed throughout the hospitalization for complications. Patients will also be contacted at 6 month to complete a quality of life questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergent laparotomy
- •Patient has injuries for which surgeon has equipoise to perform a Definitive (DEF) or Damage Control Laparotomy (DCL)
- •Age ≥16 years (age cut-off for admission to adult trauma service at Memorial Hermann Hospital-Texas Medical Center)
排除标准
- •Indication for DCL for which there is no surgeon equipoise:
- •Need for gauze packing of liver or retroperitoneum for hemorrhage control
- •Immediate need to go to Interventional Radiology for hemorrhage control
- •Concern for Abdominal Compartment Syndrome - defined as physically unable to re-approximate fascia or >10mmHg change in peak airway pressure during fascial closure
- •Hemodynamic instability - defined as persistent hypotension, ongoing transfusion requirement, or continuous vasopressor use
- •Indication for DEF for which there is no surgeon equipoise:
- •Negative and non-therapeutic laparotomies
- •Isolated cystorrhaphy
- •Prisoners
- •Known pregnancy
- •Patients with burns > 20% of total body surface area
- •Patient/legally authorized representative opted out of exception from informed consent (opt out bracelet)
- •Currently enrolled in another interventional study
结局指标
主要结局
Number of Participants Who Died or Had Major Abdominal Complication (MAC)
时间窗: 30 days
Major abdominal complication (MAC) is defined as development of an organ/space surgical site infection, enteric suture line failure, fascial dehiscence, or unplanned return to operating room (OR).
次要结局
- Number of ICU-free Days(30 days)
- Number of Participants With Non-abdominal Morbidities(30 days)
- Number of Hospital-free Days(30 days)
- Number of Ventilator-free Days(30 days)
- Hospital Costs(30 days)
- Patient-centered Outcomes Assessed Using the Standard Gamble(6 months after discharge from hospital)
- Patient-centered Outcomes Assessed Using the 5-level European Quality of Life Scale-5D (EuroQol-5D-5L)(6 months after discharge from hospital)
- Patient-centered Outcomes Assessed Using the Post-Traumatic Stress Disorder Check List - Civilian (PCL-C)(6 months after discharge from hospital)
研究者
John Andrew Harvin
MD
The University of Texas Health Science Center, Houston