Prediction of Sepsis After Flexible Ureteroscopy

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.

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Surgery--Complications Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flexible ureteroscopy

Procedure

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.

Primary outcomes

complication-sepsis

Time frame: within 48 hour after surgery

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

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Nov 8, 2019
Registry last updated: Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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