Recruiting

Observational Study

Sponsor:

Intuitive Surgical

Code:

NCT06624215

Conditions

Acute Appendicitis

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Appendectomy

Study Details

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.

Conditions

Acute Appendicitis

Study ID

NCT06624215

Start date

Nov 22, 2024

Status verified date

Oct, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Appendectomy

Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

Primary outcome measure

  • 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 ]
  • 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 ]
  • Discharge disposition [ Time Frame: Discharge from the hospital (check-out time), up to approximately one week. ]
  • Blood Transfusion [ Time Frame: Intraoperative and discharge from the hospital (check-out time), up to approximately one week. ]

Central Contacts and Locations

Central contacts

Auben Debus, Sr. Clinical Study Manager

408-523-5294auben.debus@intusurg.com

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Adara McCarty

614-685-5568adara.mccarty@osumc.edu

Legacy Emanuel Hospital & Health Center

Recruiting

Portland, Oregon, United States, 97232

Contacts

Brenna Bogle

503-413-3508bbogle@lhs.org

Christus Santa Rosa Health Care Corporation

Recruiting

New Braunfels, Texas, United States, 78130

Contacts

Rosa Gonzalez, BSN, RN, CCRC

830-221-3229rosa.gonzalez@christushealth.org

More Information

Sponsor

Intuitive Surgical

Last update posted

Apr 22, 2026

Last verified

Oct, 2025

Keywords

  • Appendectomy
  • Robotic-assisted
  • Acute care
  • Laparoscopic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intuitive Surgical on 2026-04-22.