A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Intuitive Surgical
- Enrollment
- 1,000
- Locations
- 6
- Primary Endpoint
- Length of stay
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Subject with appendiceal neoplasms
- •Subject who underwent a single-port appendectomy
- •Subject who was pregnant or breastfeeding at the time of the procedure
Arms & Interventions
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.
Intervention: 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.
Intervention: Appendectomy (Procedure)
Outcomes
Primary Outcomes
Length of stay
Time Frame: 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
Time Frame: 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
Time Frame: Intraoperative
Adverse events
Time Frame: Intraoperative and postoperative out to 30 days from procedure date
Procedure time
Time Frame: Intraoperative
Conversion
Time Frame: Intraoperative
Mortality rate through 30 days
Time Frame: Intraoperative and postoperative out to 30 days from procedure date
All cause
Unplanned procedure-related readmission rate through 30 days
Time Frame: Discharge through 30 days
Concomitant procedures
Time Frame: Intraoperative
Estimated blood loss
Time Frame: Intraoperative
Severity of appendicitis
Time Frame: Preoperative
Unplanned procedure-related reoperation rate through 30 days
Time Frame: Postoperative through 30 days
Blood Transfusion
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported