Retrospective Acute Care Appendectomy Study

Not yet recruiting

• Conditions: Acute Appendicitis
• Interventions: Procedure: Appendectomy

• Registration Number: NCT06624215
• Lead Sponsor: Intuitive Surgical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-03
• Study Start: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic-assisted appendectomy subjects	Appendectomy	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	Appendectomy	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.

Primary Outcome Measures

Name	Time	Method
Operative time	Intraoperative
Adverse events	Intraoperative and postoperative out to 30 days from procedure date
Procedure time	Intraoperative
Conversion	Intraoperative
Mortality rate through 30 days	Intraoperative and postoperative out to 30 days from procedure date	All cause
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	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.
Discharge disposition	Discharge from the hospital (check-out time), up to approximately one week.	Where the subject was discharged to when released from the hospital
Blood Transfusion	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.