- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01969487
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
Status
Afsluttet
Intervention / Behandling
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
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins Hospital
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins Bayview 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 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 |
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Eksperimentel: Preoperative warm-up on simulator
Trainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery.
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Ingen indgriben: No preoperative warm-up
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Global rating score - GEARS approach
Tidsramme: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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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).
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Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Global rating score - OSATS approach
Tidsramme: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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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.
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Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Surgical skill metrics
Tidsramme: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Computed using surgical tool motion and/or video of procedure.
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Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Driftstid
Tidsramme: Intraoperativt
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Intraoperativt
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Estimeret blodtab
Tidsramme: Intraoperativt
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Intraoperativt
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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.
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We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
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Change in hematocrit
Tidsramme: Postoperative days 1, 2, and 3
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Postoperative days 1, 2, and 3
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Readmission or emergency room visit
Tidsramme: 6 weeks after discharge from hospital (following initial admission for surgery)
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6 weeks after discharge from hospital (following initial admission for surgery)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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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