Kidney CalculiRIRS-ERGNCT07763600
Effect of Anesthesia Type on Surgeon Workload During Endoscopic Kidney Stone Surgery
An observational study of Kidney Calculi, run by Malatya Governor Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- General Anesthesia (GA) and Spinal Anesthesia (SA)
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Malatya Governor Research Hospital
Malatya, Malatya, 44000
About this study
Official title: 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.
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.
- Conditions
- Kidney Calculi
- Being tested
- General Anesthesia (GA), Spinal Anesthesia (SA)
- Keywords
- Retrograde Intrarenal Surgery, Flexible Ureteroscopy, General Anesthesia, Spinal Anesthesia, Surgical Ergonomics, Surgery Task Load Index, SURG-TLX
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia (GA)Procedure or surgery
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 (SA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Spinal Anesthesia (SA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 15-30 minutes after completion of the surgical procedure
Secondary outcomes (6)
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.
Measured: Within 15-30 minutes after completion of the surgical procedure
Operative Duration
Operative duration will be recorded in minutes from the routine intraoperative records and compared between the general anesthesia and spinal anesthesia groups.
Measured: During the surgical procedure
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.
Measured: Within the first 2 hours after surgery
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.
Measured: During the surgical procedure
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.
Measured: Within 30 days after surgery
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.
Measured: At routine postoperative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malatya Governor Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Kızılay, Malatya Governor Research Hospital
- Investigators
- Emrah Kızılay, MD, Principal investigator, Malatya Governor Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763600
- Sponsor's protocol ID
- RIRS-ERG-2026-01
- Acronym
- RIRS-ERG
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and institutional data protection considerations.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia Type on Surgical Ergonomics in Patients Undergoing Flexible Ureteroscopy and Retrograde Intrarenal Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07763600
- Acronym / sponsor ID
- RIRS-ERG / RIRS-ERG-2026-01
- Conditions
- Kidney Calculi
- Keywords
- Retrograde Intrarenal Surgery, Flexible Ureteroscopy, General Anesthesia, Spinal Anesthesia, Surgical Ergonomics, Surgery Task Load Index, SURG-TLX
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Malatya Governor Research HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | – | Procedure: General Anesthesia (GA)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. |
| Spinal Anesthesia Group | – | Procedure: Spinal Anesthesia (SA)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | General Anesthesia Group |
| 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. | Procedure or surgery | Spinal Anesthesia Group |
Primary outcome
Total Weighted Surgery Task Load Index (SURG-TLX) Score
Time frame: 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.
6 secondary outcomes
Weighted SURG-TLX Domain Scores
Time frame: Within 15-30 minutes after completion of the surgical procedure
Operative Duration
Time frame: During the surgical procedure
Postoperative Pain Intensity
Time frame: Within the first 2 hours after surgery
Intraoperative Complications
Time frame: During the surgical procedure
Postoperative Complications
Time frame: Within 30 days after surgery
Stone-Free Status
Time frame: At routine postoperative follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 21597890Wilson 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.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and institutional data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emrah Kızılay, MD principal investigator
Malatya Governor Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi, run by Malatya Governor Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emrah Kızılay, MD (+905363887322, drkizilayemrah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Weighted Surgery Task Load Index (SURG-TLX) Score (time frame: Within 15-30 minutes after completion of the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07763600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.