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A clinical trial to compare the amount of bleeding and surgical complications of percutaneous nephrolithotomy in a group that had a balloon nephrostomy compared to a normal nephrostomy

Not Applicable
Recruiting
Conditions
kidney stone.
Calculus of kidney
N 20.0
Registration Number
IRCT20160406027253N2
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
102
Inclusion Criteria

Kidney stones are candidates for PCNL surgery
Age 18 years and older
Placement in group one ASA I,II in terms of anesthesia risk

Exclusion Criteria

Age under 18 years old
Patients with kidney stones with anatomical abnormalities(Renal malrotation, pelvic kidney, horseshoe kidney
Paranchymal atrophy and kidney with little function
Placement in group one ASA III in terms of anesthesia risk
High Creatinine
BMI over 30 Kg/m2
Untreated coagulation disorder
Aspirin consumption in the last 7 days
Taking NSAID drugs in the last 5 days
Untreated active urinary tract infection

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Stone cleaning. Timepoint: 24 hours after the intervention. Method of measurement: Plain radiography of the abdomen.;Transfusion Rate. Timepoint: From the start of surgery until time of discharge from the hospital. Method of measurement: The number of units of blood transfused during hospitalization.;Urinary leak volume. Timepoint: During hospitalization. Method of measurement: CC volume of urine removed from the nephrostomy site.;Changes in hemoglobin. Timepoint: End of operation and 24 hours after surgery. Method of measurement: mg/dL based on laboratory measurement.
Secondary Outcome Measures
NameTimeMethod
Creatinine change. Timepoint: preoperative and 24-48 hours after surgery. Method of measurement: based on serum levels of creatinine before and after operation.;Hospitalization duration. Timepoint: from hospitalization to discharge. Method of measurement: days.
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