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Not yet recruitingNCT07763600RIRS-ERGUpdated Aug 13, 2026

Effect of Anesthesia Type on Surgeon Workload During Endoscopic Kidney Stone Surgery

An observational study in Kidney Calculi, sponsored by Malatya Governor Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Malatya Governor Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 48 studies in Kidney Calculi with a site in Turkey — 21 open to participants now, 22 under way, none of them phase 3. Kidney Calculi · Turkey.

Planned enrollment
10th of 13
120 · median 184
Started
2026
with 13 others
Observational
13 of 48
5 open now
Primary completion
2027-01
later than 12 of 21 live
Registered
44th of 48
by date

Among the 48 studies in Kidney Calculi with a site in Turkey, this one is the 10th largest by planned enrollment of the 13 observational ones, is one of 14 that started in 2026, is one of 13 observational ones, reaches primary completion later than 12 of the 21 other live ones, and was the 44th registered.

By phase

48 studies; the count open now beside each. This study's row is marked.

No phase32 · 15 open
Observationalthis study13 · 5 open
Phase 43 · 1 open

By the year they started

First in 2014; this study’s year is marked. 14 started in 2026.

Size and results

Median enrollment 90 across the 35 interventional studies, 184 across the 13 observational. Of the 18 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Kidney Calculi

Browse trials for

Keywords

  • Retrograde Intrarenal Surgery
  • Flexible Ureteroscopy
  • General Anesthesia
  • Spinal Anesthesia
  • Surgical Ergonomics
  • Surgery Task Load Index
  • SURG-TLX
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: General Anesthesia (GA)

  • 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.

    Procedure: Spinal Anesthesia (SA)

Interventions

  • ProcedureGeneral 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.

  • ProcedureSpinal 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.

06

What researchers measure

Primary outcomes

  1. Total Weighted Surgery Task Load Index (SURG-TLX) Score

    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.

    Time frame: Within 15-30 minutes after completion of the surgical procedure

Secondary outcomes

  1. Weighted SURG-TLX Domain Scores

    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.

    Time frame: Within 15-30 minutes after completion of the surgical procedure

  2. Operative Duration

    Operative duration will be recorded in minutes from the routine intraoperative records and compared between the general anesthesia and spinal anesthesia groups.

    Time frame: During the surgical procedure

  3. Postoperative Pain Intensity

    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.

    Time frame: Within the first 2 hours after surgery

  4. Intraoperative Complications

    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.

    Time frame: During the surgical procedure

  5. Postoperative Complications

    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.

    Time frame: Within 30 days after surgery

  6. Stone-Free Status

    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.

    Time frame: At routine postoperative follow-up

07

Study locations

1 site
  • Malatya Governor Research Hospital
    Malatya, Malatya 44000, Turkey (Türkiye)
08

References and documents

Publications

  • Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4. PubMed 21597890 ↗

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared due to participant confidentiality and institutional data protection considerations.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.

Of 39 observational studies under Kidney Calculi, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 13, 2026
StartEst.
Sep 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07763600
Lead sponsor
Malatya Governor Research Hospital
Responsible party
Emrah Kızılay (Urologist, Malatya Governor Research Hospital) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Emrah Kızılay, MD
Contact
drkizilayemrah@gmail.com
+905363887322
Emrah Kızılay, MD
principal investigator · Malatya Governor Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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