A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy
概览
- 阶段
- 不适用
- 干预措施
- Appendectomy
- 疾病 / 适应症
- Acute Appendicitis
- 发起方
- Intuitive Surgical
- 入组人数
- 1000
- 试验地点
- 6
- 主要终点
- Operative time
- 状态
- 招募中
- 最后更新
- 10天前
概览
简要总结
The purpose of this retrospective study is to compare perioperative data for subjects who have undergone an emergent or urgent robotic-assisted or laparoscopic appendectomy for acute appendicitis.
研究者
入排标准
入选标准
- •Subject is 22 years of age or older at time of procedure
- •Subject has undergone robotic-assisted or laparoscopic emergent or urgent appendectomy for acute appendicitis between 2018 and 30 days prior to IRB approval
排除标准
- •Subject with appendiceal neoplasms
- •Subject who underwent a single-port appendectomy
- •Subject who was pregnant or breastfeeding at the time of the procedure
研究组 & 干预措施
Robotic-assisted appendectomy subjects
Approximately 500 subjects will be enrolled in this group who have undergone an emergent or urgent robotic-assisted appendectomy for acute appendicitis in a reverse chronological order from 30 days prior to IRB approval going back to 2018.
干预措施: Appendectomy
Laparoscopic appendectomy subjects
Approximately 500 subjects will be enrolled in this group who have undergone an emergent or urgent laparoscopic appendectomy for acute appendicitis in a reverse chronological order from 30 days prior to IRB approval going back to 2018.
干预措施: Appendectomy
结局指标
主要结局
Operative time
时间窗: Intraoperative
Adverse events
时间窗: Intraoperative and postoperative out to 30 days from procedure date
Procedure time
时间窗: Intraoperative
Conversion
时间窗: Intraoperative
Mortality rate through 30 days
时间窗: Intraoperative and postoperative out to 30 days from procedure date
All cause
Unplanned procedure-related readmission rate through 30 days
时间窗: Discharge through 30 days
Concomitant procedures
时间窗: Intraoperative
Estimated blood loss
时间窗: Intraoperative
Severity of appendicitis
时间窗: Preoperative
Unplanned procedure-related reoperation rate through 30 days
时间窗: Postoperative through 30 days
Length of stay
时间窗: Start of procedure to discharge from the hospital (check-out time), up to approximately one week
Total number of days the subject stayed in the hospital after the index procedure prior to being discharged.
Discharge disposition
时间窗: Discharge from the hospital (check-out time), up to approximately one week.
Where the subject was discharged to when released from the hospital
Blood Transfusion
时间窗: Intraoperative and discharge from the hospital (check-out time), up to approximately one week.
Any occurrence of blood transfusion either at the time of the procedure or at any point during the post-procedure hospitalization until the participant is discharged.