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Completed

NCT Number: NCT04551820

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

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

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Key information

Conditions

Cholecystectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. David's Medical Center

Austin, Texas, 78758, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Exclusion criteria

  • Cholecystectomy was performed as a secondary procedure.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Conversion to open

    Time frame: Intra-operative

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

  2. Number of adverse events

    Time frame: Intra-operative through the 30 day follow-up period

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

  3. Re-admissions

    Time frame: 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

  4. Re-operations

    Time frame: 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

Secondary outcomes

  1. Operative time

    Time frame: Intra-operative

    Operative time, defined as first incision to closure of the incision

  2. Use of intra-operative imaging

    Time frame: Intra-operative

    The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography

  3. Length of Hospital Stay (LOS)

    Time frame: From admission to discharge, up to approximately one week

    How long the patient was admitted to the hospital

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Acronym: SPARC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Nov 26, 2021

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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