- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01875679
Comprehensive Surgical Coaching
Surgical Coaching -Using Error Debriefing, Behavioral Modeling and Error Recognition to Enhance Surgical Skill
Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training.
The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.
연구 개요
상태
상세 설명
Design The study design is a randomized, controlled trial involving evaluation of a study and a conventionally trained group at pretest and posttest.
Participants The study and control groups will consist of senior surgical residents (PGY 3-5) and surgical fellows involved in minimally invasive surgery (MIS).
Inclusion: Since concurrent operative training in the operating room (OR) in the technique of MIS is a prerequisite for this study, only residents and fellows on rotations with a practice focus on MIS during the time period of the study will be eligible for participation.
Exclusion: Individuals with severe illnesses precluding performance in the OR will not be included.
Outcome measures: Surgical performance will be assessed using a global rating scale as well as through tabulation of observed intraoperative technical errors. Primary outcome measure is surgical skill level before and after targeted training.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Ontario
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Toronto, Ontario, 캐나다, M5B 1W8
- St. Michael's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- surgical residents and fellows on rotations with a practice focus on minimally invasive surgery during the time period of the study
Exclusion Criteria:
- individuals with severe illnesses precluding performance in the OR
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Conventional residency training
This group will continue their regular surgical training without any specific intervention.
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Surgical training as per participant's residency program
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실험적: Comprehensive Surgical Coaching (SCS)
The participants will receive an analysis of the technical performance as observed on baseline recordings of the index procedure.
Training needs will be identified and a personalized coaching concept will be designed.
Coaching sessions will include video debriefing of the participant's performance (sample recordings will be submitted by the participant during the sessions) and video assisted behavioral modeling using examples of good and poor technical performance.
Coaching will also target increasing awareness of weaknesses and potential pitfalls in surgical technical task execution (error recognition).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Surgical Technical Skill
기간: After 8 weeks of participation
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Surgical skill measures as recorded on a procedure specific global rating scale, Objective Structured Assessment of Technical Skills (OSATS) and bariatric OSATS (BOSATS) scores and by tabulation of technical errors, Generic Error Rating Tool (GERT) observed during the index procedures.
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After 8 weeks of participation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Learning curves
기간: Throughout 8 weeks of participation
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Development of skill and reduction of errors will be assessed in relation to number of procedures performed to obtain learning curves for each study group. Surgical technical skill will be assessed by OSATS and BOSATS scales, errors will be recorded by GERT checklist |
Throughout 8 weeks of participation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Teodor P Grantcharov, MD. PhD, St. Michael's Hospital (Toronto, Canada)
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CSC2013
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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