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Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills

9. november 2020 opdateret af: Johns Hopkins University

Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes

Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room. Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Hospital
      • Baltimore, Maryland, Forenede Stater, 21224
        • Johns Hopkins Bayview Medical Center

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution;
  • Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer.

Exclusion Criteria:

  • Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Preoperative warm-up on simulator
Trainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery.
Ingen indgriben: No preoperative warm-up

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Global rating score - GEARS approach
Tidsramme: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills (OSATS) and the Global Evaluative Assessment of Robotic Surgery (GEARS).
Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Global rating score - OSATS approach
Tidsramme: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills and the Global Evaluative Assessment of Robotic Surgery.
Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Surgical skill metrics
Tidsramme: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Computed using surgical tool motion and/or video of procedure.
Assessed during the surgery (scheduled immediately following warm-up/no warm-up)

Sekundære resultatmål

Resultatmål
Tidsramme
Driftstid
Tidsramme: Intraoperativt
Intraoperativt
Estimeret blodtab
Tidsramme: Intraoperativt
Intraoperativt
Length of hospital stay
Tidsramme: We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
Change in hematocrit
Tidsramme: Postoperative days 1, 2, and 3
Postoperative days 1, 2, and 3
Readmission or emergency room visit
Tidsramme: 6 weeks after discharge from hospital (following initial admission for surgery)
6 weeks after discharge from hospital (following initial admission for surgery)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Grace CC Chen, M.D., Johns Hopkins University

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

1. december 2012

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

25. september 2013

Først indsendt, der opfyldte QC-kriterier

24. oktober 2013

Først opslået (Skøn)

25. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NA_00074621
  • WU_00074621 (Anden identifikator: Other)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Preoperative warm-up on simulator

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