Acute AppendicitisNCT06624215
Retrospective Acute Care Appendectomy Study
An observational study of Acute Appendicitis, run by Intuitive Surgical at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Nov 2024to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Who may be able to join
- 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
Who cannot join
- Subject with appendiceal neoplasms
- Subject who underwent a single-port appendectomy
- Subject who was pregnant or breastfeeding at the time of the procedure
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University
Columbus, Ohio, 43210
Christus Santa Rosa Health Care Corporation
New Braunfels, Texas, 78130
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97232
About this study
Official title: A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy
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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 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. Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: Intraoperative
Procedure time
Measured: Intraoperative
Conversion
Measured: Intraoperative
Adverse events
Measured: Intraoperative and postoperative out to 30 days from procedure date
Mortality rate through 30 days
All cause
Measured: Intraoperative and postoperative out to 30 days from procedure date
Unplanned procedure-related readmission rate through 30 days
Measured: Discharge through 30 days
Concomitant procedures
Measured: Intraoperative
Estimated blood loss
Measured: Intraoperative
Severity of appendicitis
Measured: Preoperative
Unplanned procedure-related reoperation rate through 30 days
Measured: Postoperative through 30 days
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
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.
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.
- First posted2 Oct 2024
- Study start22 Nov 2024
- Primary completion31 Oct 2025
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624215
- Sponsor's protocol ID
- ISI MP-APP-01
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy
- ClinicalTrials.gov ID
- NCT06624215
- Acronym / sponsor ID
- ISI MP-APP-01
- Conditions
- Acute Appendicitis
- Keywords
- Appendectomy, Robotic-assisted, Acute care, Laparoscopic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted appendectomy subjects | – | Procedure: AppendectomyApproximately 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. |
| Laparoscopic appendectomy subjects | – | Procedure: AppendectomyApproximately 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Subject with appendiceal neoplasms
- Subject who underwent a single-port appendectomy
- Subject who was pregnant or breastfeeding at the time of the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendectomyRobotic-assisted or laparoscopic appendectomy for acute appendicitis. | Procedure or surgery | Laparoscopic appendectomy subjects, Robotic-assisted appendectomy subjects |
Primary outcome
Operative time
Time frame: Intraoperative
Procedure time
Time frame: Intraoperative
Conversion
Time frame: Intraoperative
Adverse events
Time frame: Intraoperative and postoperative out to 30 days from procedure date
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Intuitive Surgical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.