NCT07763600

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Kidney Calculi

Keywords

Retrograde Intrarenal SurgeryFlexible UreteroscopyGeneral AnesthesiaSpinal AnesthesiaSurgical ErgonomicsSurgery Task Load IndexSURG-TLX

Outcome Measures

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.

    Within 15-30 minutes after completion of the surgical procedure

Secondary Outcomes (6)

  • Weighted SURG-TLX Domain Scores

    Within 15-30 minutes after completion of the surgical procedure

  • Operative Duration

    During the surgical procedure

  • Postoperative Pain Intensity

    Within the first 2 hours after surgery

  • Intraoperative Complications

    During the surgical procedure

  • Postoperative Complications

    Within 30 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

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

General Anesthesia (GA)PROCEDURE

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.

General Anesthesia Group
Spinal Anesthesia (SA)PROCEDURE

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.

Spinal Anesthesia Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Governor Research Hospital

Malatya, Malatya, 44000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21597890BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Anesthesia, GeneralAnesthesia, Spinal

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Officials

  • Emrah Kızılay, MD

    Malatya Governor Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emrah Kızılay, MD

CONTACT

+905363887322drkizilayemrah@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urologist

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)