Prediction of Sepsis After Flexible Ureteroscopy

Prediction of Sepsis After Flexible Ureteroscopy in Patients With Proximal Ureteral Stone by Using Preoperative Factors

Sepsis is a lethal complication of flexible ureteroscopy. The aim of this study is to identify predictors of sepsis after flexible ureteroscopy in patients with solitary proximal ureteral stones.

Study Overview

• Status: Completed
• Conditions: Sepsis; Surgery--Complications; Urolithiasis
• Intervention / Treatment: Procedure: flexible ureteroscopy

• Study Type: Observational
• Enrollment (Actual): 759

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients are enrolled in Wuhan Tongji Hospital from January 2012 to December 2018. Patient data is collected from institutional medical record archives.

Description

Inclusion Criteria:

• history of fURS to treat unilateral, solitary, and proximal ureteral stones
• age ≥18 years

Exclusion Criteria:

• anatomical renal abnormalities such as transplant kidney, solitary kidney, horseshoe kidney, and kidney duplication

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

proximal ureteral stone patient

Procedure: flexible ureteroscopy; flexible ureteroscopy is used to removed the stone. If a double-J stent was inserted pre-operatively, it was removed at the beginning of surgery. Rigid ureteroscopy was routinely used for ureteral dilatation before fURS. A 0.035 mm guidewire was advanced through the urethral and ureteral meatuses to the renal pelvis under direct rigid ureteroscope vision. A 14-Fr ureteral access sheath (Cook Medical, Bloomington, IN) was then passed over the wire to the ureteropelvic junction, and 7.5-Fr fURS (Flex-X2, Karl Storz, Germany) was performed through the sheath. Intrarenal pressure was stabilized by a pressure-sensitive pump (Shenda Medical, China). Holmium: yttrium-aluminum-garnet laser was used to fragment the stones. After lithotripsy, 6-Fr double-J stent was routinely inserted in all cases for 2-4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication-sepsis	sepsis is defined as the concurrence of infection and at least 2 of the following 4 criteria: (1) body temperature >38°C, (2) heart rate >90/minute, (3) respiratory rate >20/minute, and (4) leukocyte count <4,000 cells/μL or >12,000 cells/μL	within 48 hour after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Urolithiasis
• Other Study ID Numbers: 2019S1035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No