Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter

NCT06592469 | Not Yet Recruiting DMC

• 1 other identifier: Outcome of Ureteroscopy
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter

Conditions

Stone Ureter

Keywords

URS

Outcome Measures

Primary Outcomes (1)

• Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter

  • Stone free rate with a mean operative time of 1 hr by MSCTKUB or Plain KUB to determine residual stones post operative

  1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative

Secondary Outcomes (3)

• • Rate of intraoperative findings in each group.

  Intraoperative

• • The rate of complication in each group

  Intraoperative by ureteroscope and one day post operative by MSCT

• • The rate of stone impaction in each group

  Intraoperative by ureteroscope

Study Arms (2)

Fresh cases

Outcome of URS in fresh stone ureter

Procedure: Ureteroscopy

Recurrent cases

Outcome of URS in recurrent cases of stone ureter post ESWL ,URS , open surgery

Procedure: Ureteroscopy

Interventions

Ureteroscopy PROCEDURE

URS is done to each group to reveal outcome of stone free rate in fresh versus recurrent cases of stone ureter

Also known as: URS

Fresh cases; Recurrent cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

.4. 2- Study subjects: 1. Inclusion criteria: * all cases with middle and lower ureteric stone candidate for endoscopy. * Stone 15mm or less. 2. Exclusion criteria: * Patients with a ureteral stent. * Patient refusing participation. * Pregnant woman. * Active urinary tract infection. * Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile. 3. Sample Size Calculation: Based on previously reported frequency of primary failure of ureteocopy in case of recurrent stone that ranged between 1-37% (\*reference)\* a total sample size of 62 patients will be required ( 31 patients in each arm) with the following assumption; alpha error 5%, 80% power with 95% confidence interval

You may qualify if:

• all cases with middle and lower ureteric stone candidate for endoscopy.
• Stone 15mm or less.

You may not qualify if:

• Patients with a ureteral stent.
• Patient refusing participation.
• Pregnant woman.
• Active urinary tract infection.
• Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, Egypt

Location

Related Links

• Factors predicting duration and success of semirigid ureteroscopy for ureteral stones in different localizations
• Assessment of factors affecting the spontaneous passage of lower ureteric calculus on the basis of lower ureteric calculus diameter, density, and plasma C-reactive protein level. Urology Annal
• Stone composition independently predicts stone size in 18,029 spontaneously passed stones
• Outcomes of Shock Wave Lithotripsy and Ureteroscopy for Treatment of Pediatric Urolithiasis
• Pushing the boundaries of ureteroscopy: current status and future perspectives
• Semirigid Ureteroscopy: Step by Step
• Complications of pneumatic ureterolithotripsy in the early postoperative period
• Complications of 2735 retrograde semirigid ureteroscopy procedures: a single-center experience
• Endoscopic features of impacted ureteral stones
• Predictive factors for intraoperative complications in semirigid ureteroscopy: analysis of 1235 ballistic ureterolithotripsies
• Revisiting the predictive factors for intra-operative complications of rigid ureteroscopy: a 15-year experience

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Fathy Gaber Mahmoud Alanany, Prof of URO

  Assiut University

  STUDY DIRECTOR

• Mahmoud M. Shalaby, Prof of URO

  Assiut University

  STUDY DIRECTOR

• Nasreldin Abdeal Mohammed, Ass Prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Amr Moustafa Hussein Soliman, Resident dr

CONTACT

+201140340697; amr.mustafa303@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)