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Effect of Anesthesia Type on Surgeon Workload During Endoscopic Kidney Stone Surgery (RIRS-ERG)

10. srpna 2026 aktualizováno: Emrah Kızılay, Malatya Governor Research Hospital

Effect of Anesthesia Type on Surgical Ergonomics in Patients Undergoing Flexible Ureteroscopy and Retrograde Intrarenal Surgery: A Prospective Observational Study

This prospective observational study aims to evaluate the association between anesthesia type and surgeon-perceived workload and surgical ergonomics in adult patients undergoing flexible ureteroscopy and retrograde intrarenal surgery (RIRS) for kidney stones. Patients will be classified according to the anesthesia administered during routine clinical care as general anesthesia or spinal anesthesia. The choice of anesthesia will be determined by routine clinical practice and the anesthesiology team and will not be assigned by the study protocol. Surgeon workload will be assessed immediately after surgery using the Surgery Task Load Index (SURG-TLX). Perioperative outcomes, including operative time, procedural characteristics, postoperative pain, complications, and stone-free status, will also be evaluated.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

120

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Turecko (Türkiye)
    • Malatya
      • Malatya, Malatya, Turecko (Türkiye), 44000
        • Malatya Governor Research Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Adult patients with kidney stones who are scheduled to undergo elective flexible ureteroscopy and retrograde intrarenal surgery (RIRS) at the study center and meet the predefined eligibility criteria.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Postup: General Anesthesia (GA)
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.
Postup: Spinal Anesthesia (SA)
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total Weighted Surgery Task Load Index (SURG-TLX) Score
Časové okno: Within 15-30 minutes after completion of the surgical procedure
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.
Within 15-30 minutes after completion of the surgical procedure

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Weighted SURG-TLX Domain Scores
Časové okno: Within 15-30 minutes after completion of the surgical procedure
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.
Within 15-30 minutes after completion of the surgical procedure
Operative Duration
Časové okno: During the surgical procedure
Operative duration will be recorded in minutes from the routine intraoperative records and compared between the general anesthesia and spinal anesthesia groups.
During the surgical procedure
Postoperative Pain Intensity
Časové okno: Within the first 2 hours after surgery
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.
Within the first 2 hours after surgery
Intraoperative Complications
Časové okno: During the surgical procedure
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.
During the surgical procedure
Postoperative Complications
Časové okno: Within 30 days after surgery
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.
Within 30 days after surgery
Stone-Free Status
Časové okno: At routine postoperative follow-up
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.
At routine postoperative follow-up

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Malatya Governor Research Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Emrah Kızılay, MD, Malatya Governor Research Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. ledna 2027

Dokončení studie (Odhadovaný)

1. ledna 2027

Termíny zápisu do studia

První předloženo

10. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

10. srpna 2026

První zveřejněno (Aktuální)

13. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RIRS-ERG-2026-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be publicly shared due to participant confidentiality and institutional data protection considerations.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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