Health TrialsbyHealthPanel

Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter

ConditionStone Ureter
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Stone 15mm or less.

Disqualifiers

• Patients with a ureteral stent.

Patient refusing participation.

Pregnant woman.

Active urinary tract infection.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ureteroscopy

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Fresh cases1 intervention
Group B: Recurrent cases1 intervention

Trial outcomes

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

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

Secondary outcomes

1

• Rate of intraoperative findings in each group.

• Rate intraoperative findings in each group by ureteroscope

Time frame
Intraoperative
2

• The rate of complication in each group

To determine rate of intraoperative complications as bleeding , ureteric perforation , residual stones

Time frame
Intraoperative by ureteroscope and one day post operative by MSCT
3

• The rate of stone impaction in each group

Rate of stone impaction in each group fresh and recurrent cases

Time frame
Intraoperative by ureteroscope

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: