Care Pathway for Patients Undergoing VATS Lobectomy or Segmentectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3.
研究概览
简要总结
The goal of this study is to create a unified SOP for care of subjects undergoing VATS lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic centers have created standardized algorithms for the care of their subjects and this enables the centers to determine which subjects can be placed on an accelerated pathway to discharge and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in what may be unnecessary tests to simplify patient care and likely accelerate them towards safe and more timely discharge from the hospital.
详细描述
This is a prospective, study to develop, test, fine-tune and refine an SOP for the post-operative care for patients who undergo a VATS lobectomy or segmentectomy performed by one of the surgeons in The Division of Thoracic Surgery. This study will be conducted in two phases. Phase 1 will be focused on early feasibility of the SOP and this will be done by enrolling 50 participants among the subgroup of Thoracic VATS Surgeons who participate. An analysis will take place upon the completion of the phase 1 to look at the percentage of participants who were able to be discharged on or prior to POD 3. Upon this analysis, modifications across all areas of the care pathway will be evaluated and altered if deemed necessary by the PI and other members of the study team. This analysis will drive any modifications needed that will be incorporated into the phase II design prior to its implementation. The treating Thoracic Surgeon for each patient will follow the SOP as it is outlined and the steps the post-operative team will follow will be dependent on which phase the participant is enrolled too. Data will be collected for each participant starting just prior to the VATS operation and continue through the discharge and conclude once the participants have reached their 90-day post-discharge date. Upon discharge from the hospital the participant will enter the follow-up period of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects
- •Age ≥ 18 years
- •Subjects planned to undergo a VATS lobectomy or segmentectomy procedure for lung nodules
排除标准
- •Subjects who cannot undergo VATS surgery
- •Subjects undergoing any kind of resection in addition to VATS Lobectomy or Segmentectomy
研究组 & 干预措施
Patients undergoing VATS lobectomy or segmentectomy
Patients undergoing VATS lobectomy or segmentectomy performed by one of the surgeons in the Division of Thoracic Surgery who are then placed on this specific post-operative care pathway to determine the rate of discharge of these patients by post-operative day (POD) three.
干预措施: Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy (Other)
结局指标
主要结局
The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3.
时间窗: From date of consent until midnight of post op day 3
The primary objective of phase II is to further evaluate this SOP. The study team will also have the opportunity to refine and fine tune this SOP between phase I and phase II.
时间窗: From date of consent until midnight of post op day 3
次要结局
未报告次要终点
研究者
Scott J Swanson
Principal Investigator
Brigham and Women's Hospital