Effect of Anesthesia Type on Surgeon Workload During Endoscopic Kidney Stone Surgery (RIRS-ERG)
Effect of Anesthesia Type on Surgical Ergonomics in Patients Undergoing Flexible Ureteroscopy and Retrograde Intrarenal Surgery: A Prospective Observational Study
연구 개요
상세 설명
This is a prospective, single-center, observational study including adult patients undergoing elective flexible ureteroscopy and retrograde intrarenal surgery (RIRS) for kidney stones. Eligible patients will be enrolled consecutively. No intervention regarding the type of anesthesia or surgical technique will be assigned by the study protocol. The anesthesia technique will be selected according to routine clinical practice and the assessment of the anesthesiology team. Patients will subsequently be categorized into two observational groups: those receiving general anesthesia and those receiving spinal anesthesia.
All RIRS procedures will be performed according to standard clinical practice. Surgical steps, including the use of a ureteral access sheath, lithotripsy technique, energy source, and placement of a ureteral stent, will be determined by the treating surgeon and will not be modified for research purposes.
The primary outcome will be surgeon-perceived intraoperative workload assessed using the Surgery Task Load Index (SURG-TLX). The SURG-TLX evaluates six domains: mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions. The questionnaire will be completed by the surgeon within 15-30 minutes after completion of the procedure. Individual domain scores and the overall SURG-TLX score will be recorded.
Secondary outcomes will include operative duration, fluoroscopy time or dose when available, use of a ureteral access sheath, ureteral stent placement, intraoperative complications, postoperative complications, postoperative pain and analgesic requirement, stone-free status, and the need for additional intervention. Preoperative demographic and clinical characteristics, including age, sex, body mass index, ASA classification, comorbidities, stone characteristics, hydronephrosis, and relevant preoperative clinical data, will also be recorded.
The main analysis will compare SURG-TLX scores between the general anesthesia and spinal anesthesia groups. Potential confounding variables related to patient characteristics, stone burden, procedural factors, and operative characteristics will be considered in adjusted analyses.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Emrah Kızılay, MD
- 전화번호: +905363887322
- 이메일: drkizilayemrah@gmail.com
연구 장소
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Malatya
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Malatya, Malatya, 터키 (Türkiye), 44000
- Malatya Governor Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18 years or older
- Patients scheduled for elective flexible ureteroscopy and retrograde intrarenal surgery (RIRS) for kidney stones
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Pregnancy
- Emergency surgery, including procedures performed for sepsis, hemodynamic instability, or urgent urinary drainage
- Concomitant major surgical intervention during the same session, such as percutaneous nephrolithotomy, open surgery, or laparoscopic surgery
- Congenital renal anomalies or major anatomical abnormalities that may substantially affect the procedure
- Bilateral RIRS performed during the same operative session
- Procedures involving substantial intraoperative surgeon switching or extensive transfer of the procedure for training purposes
- Incomplete surgeon SURG-TLX assessment or missing primary outcome data
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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General Anesthesia Group
Patients undergoing flexible ureteroscopy and retrograde intrarenal surgery (RIRS) under general anesthesia as determined by routine clinical practice and the anesthesiology team.
General anesthesia will not be assigned by the study protocol.
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Exposure to general anesthesia during routine RIRS.
The anesthesia technique is selected according to routine clinical practice and anesthesiology assessment and is not assigned by the study protocol.
|
|
Spinal Anesthesia Group
Patients undergoing flexible ureteroscopy and retrograde intrarenal surgery (RIRS) under spinal anesthesia as determined by routine clinical practice and the anesthesiology team.
Spinal anesthesia will not be assigned by the study protocol.
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Exposure to spinal anesthesia during routine RIRS.
The anesthesia technique is selected according to routine clinical practice and anesthesiology assessment and is not assigned by the study protocol.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Weighted Surgery Task Load Index (SURG-TLX) Score
기간: Within 15-30 minutes after completion of the surgical procedure
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Surgeon-perceived workload will be assessed using the original weighted Surgery Task Load Index (SURG-TLX).
The instrument includes six domains: mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions.
Domain weights are determined through 15 pairwise comparisons, yielding a weight from 0 to 5 for each domain.
Each domain is then rated on a 20-point scale.
The weighted workload score for each domain is calculated by multiplying the domain weight by its rating, resulting in a score from 0 to 100.
The six weighted domain scores are summed to obtain the total SURG-TLX workload score, with higher scores indicating greater perceived surgical workload.
The total weighted SURG-TLX score ranges from 0 to 300, with higher scores indicating greater perceived surgical workload.
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Within 15-30 minutes after completion of the surgical procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weighted SURG-TLX Domain Scores
기간: Within 15-30 minutes after completion of the surgical procedure
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The six SURG-TLX domains (mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions) will be analyzed separately.
For each domain, the weight derived from the 15 pairwise comparisons (0-5) will be multiplied by the corresponding rating on the 20-point scale, yielding a weighted domain score ranging from 0 to 100.
Higher scores indicate greater workload in the respective domain.
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Within 15-30 minutes after completion of the surgical procedure
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Operative Duration
기간: During the surgical procedure
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Operative duration will be recorded in minutes from the routine intraoperative records and compared between the general anesthesia and spinal anesthesia groups.
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During the surgical procedure
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Postoperative Pain Intensity
기간: Within the first 2 hours after surgery
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Postoperative pain intensity will be assessed using a Visual Analog Scale (VAS), with higher scores indicating greater pain intensity.
Scores will be compared between the general anesthesia and spinal anesthesia groups.
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Within the first 2 hours after surgery
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Intraoperative Complications
기간: During the surgical procedure
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The occurrence of intraoperative complications during flexible ureteroscopy and RIRS will be recorded from routine operative records and compared between the general anesthesia and spinal anesthesia groups.
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During the surgical procedure
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Postoperative Complications
기간: Within 30 days after surgery
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Postoperative complications, including fever, sepsis, hematuria, and other procedure-related adverse events, will be recorded and classified according to the Clavien-Dindo classification.
The incidence and severity of complications will be compared between the general anesthesia and spinal anesthesia groups.
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Within 30 days after surgery
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Stone-Free Status
기간: At routine postoperative follow-up
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Stone-free status will be assessed during routine postoperative follow-up using the imaging modality applied in standard clinical care (e.g., ultrasonography, kidney-ureter-bladder radiography, or computed tomography) and compared between the general anesthesia and spinal anesthesia groups.
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At routine postoperative follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Emrah Kızılay, MD, Malatya Governor Research Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RIRS-ERG-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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