Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy (SPARC)
5. september 2026 opdateret af: Intuitive Surgical
SPARC: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
505
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
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Austin, Texas, Forenede Stater, 78758
- St. David's Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Regular Hours
These subjects have undergone a cholecystectomy during regular hours at the Institution.
|
The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.
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.
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|
After Hours
These subjects have undergone a cholecystectomy during after hours at the Institution.
|
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.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Re-admissions
Tidsramme: After discharge from the hospital post-procedure through the 30 day follow-up period
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Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period
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After discharge from the hospital post-procedure through the 30 day follow-up period
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Re-operations
Tidsramme: After the procedure but prior to discharge, through the 30 day follow-up period
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Re-operations related to the cholecystectomy through the 30 day follow-up period
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After the procedure but prior to discharge, through the 30 day follow-up period
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Number of Participants With Cholecystectomy Converted to Open
Tidsramme: Intra-operative
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The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach.
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Intra-operative
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Number of Adverse Events
Tidsramme: Intra-operative through the 30 day follow-up period
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Intra-operative or post-operative adverse events related to the cholecystectomy
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Intra-operative through the 30 day follow-up period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of Hospital Stay (LOS)
Tidsramme: From admission to discharge, up to approximately one week
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How long the patient was admitted to the hospital
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From admission to discharge, up to approximately one week
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Driftstid
Tidsramme: Intraoperativt
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Operationstid, defineret som første snit til lukning af snittet
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Intraoperativt
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Use of Intra-operative Imaging
Tidsramme: Intra-operative
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The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
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Intra-operative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. august 2020
Primær færdiggørelse (Faktiske)
30. september 2021
Studieafslutning (Faktiske)
30. september 2021
Datoer for studieregistrering
Først indsendt
5. august 2020
Først indsendt, der opfyldte QC-kriterier
15. september 2020
Først opslået (Faktiske)
16. september 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ISI-AHC-2020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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produkt fremstillet i og eksporteret fra U.S.A.
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