Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy

Completed

• Conditions: Cholecystectomy
• Interventions: Procedure: Regular Hours; Procedure: After Hours; Device: Robotic-assisted Cholecystectomy

• Registration Number: NCT04551820
• Lead Sponsor: Intuitive Surgical

Brief Summary

A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

Detailed Description

The study is a retrospective multi-center chart review study of short-term patient outcomes through 30 days after robotic-assisted cholecystectomies performed during regular hours and after-hours. The primary outcomes include the rate of conversion to open, rate of intra-operative adverse events, the rate of post-operative adverse events relating to the cholecystectomy within 30 days, and re-admissions and re-operations relating to the cholecystectomy within 30 days. In addition, operative time, the rate of use of intra-operative imaging, and the hospital length of stay will be collected as secondary outcomes.

Study Timeline

• Study Start: 2020-08-05
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-16
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Subject between 18 and 80 years of age at the time of surgery.
• Subject underwent a robotic-assisted cholecystectomy during the study time period.

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Exclusion Criteria

• Cholecystectomy was performed as a secondary procedure.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regular Hours	Regular Hours	These subjects have undergone a cholecystectomy during regular hours at the Institution.
Regular Hours	Robotic-assisted Cholecystectomy	These subjects have undergone a cholecystectomy during regular hours at the Institution.
After Hours	After Hours	These subjects have undergone a cholecystectomy during after hours at the Institution.
After Hours	Robotic-assisted Cholecystectomy	These subjects have undergone a cholecystectomy during after hours at the Institution.

Primary Outcome Measures

Name	Time	Method
Conversion to open	Intra-operative	The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach.
Re-admissions	After discharge from the hospital post-procedure through the 30 day follow-up period	Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period
Re-operations	After the procedure but prior to discharge, through the 30 day follow-up period	Re-operations related to the cholecystectomy through the 30 day follow-up period
Number of adverse events	Intra-operative through the 30 day follow-up period	Intra-operative or post-operative adverse events related to the cholecystectomy

Secondary Outcome Measures

Name	Time	Method
Use of intra-operative imaging	Intra-operative	The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
Operative time	Intra-operative	Operative time, defined as first incision to closure of the incision
Length of Hospital Stay (LOS)	From admission to discharge, up to approximately one week	How long the patient was admitted to the hospital

Trial Locations

Locations (1)

St. David's Medical Center; 🇺🇸 Austin, Texas, United States