NCT06624215

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

September 3, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 22, 2026

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

September 3, 2024

Last Update Submit

April 20, 2026

Conditions

Acute Appendicitis

Keywords

AppendectomyRobotic-assistedAcute careLaparoscopic

Outcome Measures

Primary Outcomes (13)

  • Operative time

    Intraoperative

  • Procedure time

    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

  • Estimated blood loss

    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.

Study Arms (2)

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

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

Interventions

AppendectomyPROCEDURE

Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

Laparoscopic appendectomy subjectsRobotic-assisted appendectomy subjects

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Subject with appendiceal neoplasms
  • Subject who underwent a single-port appendectomy
  • Subject who was pregnant or breastfeeding at the time of the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97232, United States

RECRUITING

Christus Santa Rosa Health Care Corporation

New Braunfels, Texas, 78130, United States

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Auben Debus, Sr. Clinical Study Manager

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

October 2, 2024

Study Start

November 22, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 22, 2026

Record last verified: 2025-10

Locations

US(3)