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

10. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Malatya
      • Malatya, Malatya, Türkei (türkiye), 44000
        • Malatya Governor Research Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Verfahren: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Weighted Surgery Task Load Index (SURG-TLX) Score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Weighted SURG-TLX Domain Scores
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Malatya Governor Research Hospital

Ermittler

  • Hauptermittler: Emrah Kızılay, MD, Malatya Governor Research Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

10. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. August 2026

Zuerst gepostet (Tatsächlich)

13. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RIRS-ERG-2026-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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