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

Comparison of blood loss and complications in patients underwent percutaneous nephrolithotomy with balloon traction of nephrostomy and conventional methods: a randomized clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160406027253N2

Enrollment

102

Registered

2023-10-02

Start date

2023-10-02

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney stone. Calculus of kidney

Interventions

Intervention 1: Intervention group: In the intervention group, a balloon nephrostomy was placed under fluoroscopy at the infundibulum entrance of the access site from the pelvic side, and tamponade wa

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Amirhossein Kashi

Shahid Beheshti University of Medical Sciences

ahkashi@gmail.com+98 21 2258 8016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026