Clinical trial NCT06592469: Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter
Official title: The Outcome of Ureteroscopy in Fresh Versus Recurrent Cases of Stone Ureter (Post-ESWL, Endoscopy, or Open Surgery)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stone Ureter
Keywords: URS
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter

Detailed description: Urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. Approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either ESWL, ureteroscopy or open surgery according to location, site, size, and density. Ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. Semirigid URS is the gold standard of treatment for ureteral stones. High success rates and low morbidity have been reported in semirigid URS. but complications still occur in some cases. The possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful URS as age, gender, previous ESWL, and stone character. In addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful URS only seen in very few original articles as second-time URS after any procedure decreases the rate of success, so it is a point of research that Amr Moustafa aims to clarify. Amr Moustafa will conduct a prospective study to evaluate the outcomes of URS for stones in the fresh and recurrent cases.

Eligibility criteria: Inclusion Criteria:

* • all cases with middle and lower ureteric stone candidate for endoscopy.

  * Stone 15mm or less.

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.

Primary outcomes:
measure: Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter
timeFrame: 1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative
Secondary outcomes:
measure: • Rate of intraoperative findings in each group.
timeFrame: Intraoperative
measure: • The rate of complication in each group
timeFrame: Intraoperative by ureteroscope and one day post operative by MSCT
measure: • The rate of stone impaction in each group
timeFrame: Intraoperative by ureteroscope
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assiut University
Study officials:
affiliation: Assiut University
name: Fathy Gaber Mahmoud Alanany, Prof of URO
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mahmoud M. Shalaby, Prof of URO
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Nasreldin Abdeal Mohammed, Ass Prof
role: STUDY_DIRECTOR
References: