Supine vs. Prone PCNL for Large Renal Stones: A Randomized Trial in Yemen.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSana'a University
About this trial
The goal of this clinical trial is to compare the safety, cost-effectiveness, and patient recovery of two different surgical positions for percutaneous nephrolithotomy (PCNL) in adults aged 18 to 70 years who have kidney stones larger than 2 cm. The main questions it aims to answer are:
* Does the supine (lying on the back) surgical position result in fewer early postoperative complications than the traditional prone (lying on the stomach) position? * Does the supine position reduce the total surgery time, direct hospital costs, and postoperative pain?
Researchers will compare patients assigned to undergo PCNL in the supine position to those assigned to the prone position to see if the supine approach offers a safer, more cost-effective, and more comfortable recovery.
Participants will:
* Undergo standard PCNL surgery to remove their kidney stones in either the supine or prone position. * Have their pain levels, surgery time, and any early surgical complications monitored during their hospital stay. * Complete brief questionnaires regarding their overall surgical satisfaction and quality of life at 1 month and 3 months after the procedure.
Eligibility criteria
Qualifiers
Patients aged 18-70 years.
Diagnosis of solitary or multiple renal stones with a cumulative diameter greater than 2 cm, confirmed by imaging (CT KUB).
Patients eligible for standard PCNL (24-30 Fr).
American Society of Anesthesiologists (ASA) physical status I-III.
Disqualifiers
Patients with active urinary tract infection (UTI) not responding to antibiotics.
Patients with bleeding diathesis or on anticoagulant therapy that cannot be safely discontinued.
Patients with anatomical abnormalities of the kidney or urinary tract that preclude standard PCNL.
Pregnant women.
Trial design
Treatments tested in this trial
- Supine Percutaneous Nephrolithotomy (PCNL)
- Prone Percutaneous Nephrolithotomy (PCNL)
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov