Retrospective Acute Care Appendectomy Study

NCT ID: NCT06624215

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Appendicitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Appendectomy

Intervention Type PROCEDURE

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.

Appendectomy

Intervention Type PROCEDURE

Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

Interventions

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Appendectomy

Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Legacy Emanuel Hospital & Health Center

Portland, Oregon, United States

Site Status RECRUITING

Christus Santa Rosa Health Care Corporation

New Braunfels, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Auben Debus, Sr. Clinical Study Manager

Role: CONTACT

408-523-5294

Facility Contacts

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Adara McCarty

Role: primary

614-685-5568

Brenna Bogle

Role: primary

503-413-3508

Rosa Gonzalez, BSN, RN, CCRC

Role: primary

830-221-3229

Other Identifiers

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ISI MP-APP-01

Identifier Type: -

Identifier Source: org_study_id

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