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

10 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

120

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Procedura: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Weighted Surgery Task Load Index (SURG-TLX) Score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Weighted SURG-TLX Domain Scores
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Malatya Governor Research Hospital

Investigatori

  • Investigatore principale: Emrah Kızılay, MD, Malatya Governor Research Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

10 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2026

Primo Inserito (Effettivo)

13 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RIRS-ERG-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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