Retrospective Acute Care Appendectomy Study

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: Appendectomy

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Auben Debus, Sr. Clinical Study Manager; Phone Number: 408-523-5294; Email: auben.debus@intusurg.com

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Adara McCarty; Phone Number: 614-685-5568; Email: adara.mccarty@osumc.edu
  • Oregon
    • Portland, Oregon, United States, 97232
      • Recruiting
      • Legacy Emanuel Hospital & Health Center
      • Contact: Brenna Bogle; Phone Number: 503-413-3508; Email: bbogle@lhs.org
  • Texas
    • New Braunfels, Texas, United States, 78130
      • Recruiting
      • Christus Santa Rosa Health Care Corporation
      • Contact: Rosa Gonzalez, BSN, RN, CCRC; Phone Number: 830-221-3229; Email: rosa.gonzalez@christushealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Appendectomy; Robotic-assisted or laparoscopic appendectomy for acute appendicitis.
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.	Procedure: Appendectomy; Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time		Intraoperative
Operative time		Intraoperative
Estimated blood loss		Intraoperative
Conversion		Intraoperative
Adverse events		Intraoperative and postoperative out to 30 days from procedure date
Mortality rate through 30 days	All cause	Intraoperative and postoperative out to 30 days from procedure date
Unplanned procedure-related readmission rate through 30 days		Discharge through 30 days
Concomitant procedures		Intraoperative
Severity of appendicitis		Preoperative
Unplanned procedure-related reoperation rate through 30 days		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.	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	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.	Intraoperative and discharge from the hospital (check-out time), up to approximately one week.

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic; Robotic-assisted; Appendectomy; Acute care
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis; Surgical Procedures, Operative; Digestive System Surgical Procedures; Appendectomy
• Other Study ID Numbers: ISI MP-APP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No