Prediction of Sepsis After Flexible Ureteroscopy
1 other identifier
observational
759
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2019
CompletedFirst Submitted
Initial submission to the registry
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedNovember 8, 2019
November 1, 2019
2 months
November 6, 2019
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
proximal ureteral stone patient
Interventions
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.
Eligibility Criteria
All patients are enrolled in Wuhan Tongji Hospital from January 2012 to December 2018. Patient data is collected from institutional medical record archives.
You may qualify if:
- history of fURS to treat unilateral, solitary, and proximal ureteral stones
- age ≥18 years
You may not qualify if:
- anatomical renal abnormalities such as transplant kidney, solitary kidney, horseshoe kidney, and kidney duplication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 6, 2019
First Posted
November 8, 2019
Study Start
June 1, 2019
Primary Completion
August 1, 2019
Study Completion
October 20, 2019
Last Updated
November 8, 2019
Record last verified: 2019-11