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NCT Number: NCT06624215

Retrospective Acute Care Appendectomy Study

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.

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Key information

Conditions

Acute Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University, Columbus, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Appendectomy

Procedure

Robotic-assisted or laparoscopic appendectomy for acute appendicitis.

Primary outcomes

  1. Operative time

    Time frame: Intraoperative

  2. Procedure time

    Time frame: Intraoperative

  3. Conversion

    Time frame: Intraoperative

  4. Adverse events

    Time frame: Intraoperative and postoperative out to 30 days from procedure date

  5. Mortality rate through 30 days

    Time frame: Intraoperative and postoperative out to 30 days from procedure date

    All cause

  6. Unplanned procedure-related readmission rate through 30 days

    Time frame: Discharge through 30 days

  7. Concomitant procedures

    Time frame: Intraoperative

  8. Estimated blood loss

    Time frame: Intraoperative

  9. Severity of appendicitis

    Time frame: Preoperative

  10. Unplanned procedure-related reoperation rate through 30 days

    Time frame: Postoperative through 30 days

  11. 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.

  12. 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

  13. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Auben Debus, Sr. Clinical Study Manager

CONTACT

[email protected]

408-523-5294

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Retrospective Multicenter Evaluation of Short-Term Outcomes After Acute Care Appendectomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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