Retrospective Acute Care Appendectomy Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 22 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Approximately 500 patients who have undergone laparoscopic emergent or urgent appendectomies and approximately 500 patients who have undergone robotic-assisted emergent or urgent appendectomies for acute appendicitis in a reverse chronological order from 30 days prior to IRB approval going back to 2018, will be included in this study.

Trial locations and contacts

3 sites in 1 country.

About this study

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

Conditions

Acute Appendicitis

Being tested

Appendectomy

Keywords

Appendectomy, Robotic-assisted, Acute care, Laparoscopic

Medical subject headings

Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• AppendectomyProcedure or surgery

  Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Operative time

   Measured: Intraoperative

2. Procedure time

   Measured: Intraoperative

3. Conversion

   Measured: Intraoperative

4. Adverse events

   Measured: Intraoperative and postoperative out to 30 days from procedure date

5. Mortality rate through 30 days

   All cause

   Measured: Intraoperative and postoperative out to 30 days from procedure date

6. Unplanned procedure-related readmission rate through 30 days

   Measured: Discharge through 30 days

7. Concomitant procedures

   Measured: Intraoperative

8. Estimated blood loss

   Measured: Intraoperative

9. Severity of appendicitis

   Measured: Preoperative

10. Unplanned procedure-related reoperation rate through 30 days

    Measured: Postoperative through 30 days

11. Length of stay

    Total number of days the subject stayed in the hospital after the index procedure prior to being discharged.

    Measured: Start of procedure to discharge from the hospital (check-out time), up to approximately one week

12. Discharge disposition

    Where the subject was discharged to when released from the hospital

    Measured: Discharge from the hospital (check-out time), up to approximately one week.

13. Blood Transfusion

    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.

    Measured: Intraoperative and discharge from the hospital (check-out time), up to approximately one week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted2 Oct 2024
2. Study start22 Nov 2024
3. Primary completion31 Oct 2025
4. Study completion31 Jan 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Acute AppendicitisStudies of the same condition, open and under way.
• More trials run by Intuitive SurgicalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.