跳至主要内容
临床试验/NCT06624215
NCT06624215进行中(未招募)不适用

A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy

Intuitive Surgical6 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
6
主要终点
Length of stay

研究概览

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

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 (Procedure)

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 (Procedure)

结局指标

主要结局

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

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

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.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验

Retrospective Acute Care Appendectomy Study | 临床试验