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Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills

12. december 2014 opdateret af: Conor Delaney, MD, PhD, University Hospitals Cleveland Medical Center
The purpose of this study is to improve the investigators understanding of different training methods in laparoscopic colon surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

In this study the investigators use an objective evaluation system which deconstructs laparoscopic colectomy into its component steps. Critical components of the procedure as well as overall operative performance can be evaluated. This is applied to surgeons and trainee surgeons attending laparoscopic colorectal training courses using different training models to compare each model and correlate outcomes with each model to pre-course experience. This project is aimed at better educating trainers and getting better information on the validity of new training models for laparoscopic colectomy.

Aims of Project

  • To observe and assess surgical technique during laparoscopic colorectal skills training courses using a previously validated tool for formal assessment of surgical technical skills.
  • To evaluate technical errors and patterns of error during training at laparoscopic colectomy.
  • To determine outcomes and error rates with different training models and correlate these with prior surgical experience.

Number of participants/subjects in research:

Subjects will be recruited in several sites:

  • the principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses
  • Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
  • American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).

Course attendees will be informed before the start of an appropriate laparoscopic course that the study is being performed. The study will be explained to them in detail and they will be given a copy of the appropriate paperwork to review. Verbal consent will be requested. It will be explained to them that they should feel under no pressure to participate in the study, and that if they do participate that these data are not used for their evaluation. The number of cases of components of cases that they perform will not be related to participation or non-participation in the trial.

Study Design This is an observational study in which trainees' technical surgical skills are evaluated while performing specific steps of laparoscopic colectomy cases, as outlined in the accompanying datasheets. The plan is to enroll 200 participants.

At the completion of each case, forms will be completed by the trainee, and by the teaching / supervising surgeon. Independent observers cannot be used, as only an attending laparoscopic colorectal surgeon is adequately skilled to score the resident performing the case, and it is not feasible to have a second attending surgeon present during each case.

Dr Delaney will score trainees when possible using the standardized form. For courses at University Hospitals Case Medical Center (UHCMC), the colorectal faculty will be instructed in standardized assessment, and will also assess trainees. For courses at SAGES or ASCRS, the course faculty will be shown the training assessments and directed in the standardized assessment prior to evaluations.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

83

Kontakter og lokationer

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

Studiesteder

    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Case 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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Surgeons and trainee surgeons attending laparoscopic colorectal training courses.

Beskrivelse

Inclusion Criteria:

Subjects will be recruited in several sites:

  • The principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses
  • Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
  • American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).

Exclusion Criteria:

Not applicable

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Surgeons
Surgeons and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience. .
Trainee Surgeons
Surgeon and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To observe and assess surgical technique used by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses.
Tidsramme: one year
To observe and assess surgical technique by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses using a previously validated tool for formal assessment of surgical technical skills.
one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate technical errors and patterns of error by surgeons and surgeon trainees during training of laparoscopic colectomy.
Tidsramme: one year
To evaluate technical errors and patterns of error of surgeons and surgeon trainees during training at laparoscopic colectomy. To determine outcomes and error rates with different training models and correlate these with prior surgical experience
one year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Conor P Delaney, MD, PhD, University Hospitals Cleveland Medical Center

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. september 2009

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

29. april 2010

Først indsendt, der opfyldte QC-kriterier

6. maj 2010

Først opslået (Skøn)

7. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2014

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 07-09-04 (Anden identifikator: Unversity Hospitals Case Medical Center)

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 .

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