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

NCT04551820 | Completed FDA Device

• 1 other identifier: ISI-AHC-2020
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholecystectomy

Outcome Measures

Primary Outcomes (4)

• Conversion to open

  The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach.

  Intra-operative

• Number of adverse events

  Intra-operative or post-operative adverse events related to the cholecystectomy

  Intra-operative through the 30 day follow-up period

• Re-admissions

  Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period

  After discharge from the hospital post-procedure through the 30 day follow-up period

• Re-operations

  Re-operations related to the cholecystectomy through the 30 day follow-up period

  After the procedure but prior to discharge, through the 30 day follow-up period

Secondary Outcomes (3)

• Operative time

  Intra-operative

• Use of intra-operative imaging

  Intra-operative

• Length of Hospital Stay (LOS)

  From admission to discharge, up to approximately one week

Study Arms (2)

Regular Hours

These subjects have undergone a cholecystectomy during regular hours at the Institution.

Procedure: Regular Hours; Device: Robotic-assisted Cholecystectomy

After Hours

These subjects have undergone a cholecystectomy during after hours at the Institution.

Procedure: After Hours; Device: Robotic-assisted Cholecystectomy

Interventions

Regular Hours PROCEDURE

The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.

Regular Hours

After Hours PROCEDURE

The after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday.

After Hours

Robotic-assisted Cholecystectomy DEVICE

With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.

After Hours; Regular Hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.

You may qualify if:

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

You may not qualify if:

• Cholecystectomy was performed as a secondary procedure.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

St. David's Medical Center

Austin, Texas, 78758, United States

Location

Related Publications (1)

• Choudhry V, Patel YK, McIntosh BB, Badrudduja M, Jandali M, Vijan S, Brown K. Retrospective multi-center study of robotic-assisted cholecystectomy: after-hours surgery and business-hours surgery outcomes. J Robot Surg. 2024 Jan 20;18(1):48. doi: 10.1007/s11701-023-01765-x.

  PMID: 38244145 DERIVED

MeSH Terms

Interventions

After-Hours Care

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: September 16, 2020
• Study Start: August 5, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)