An interventional study of Supine Percutaneous Nephrolithotomy (PCNL) and Prone Percutaneous Nephrolithotomy (PCNL) in Kidney Calculi and Nephrolithiasis, sponsored by Sana'a University. Not yet recruiting at 1 site in Yemen. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Sana'a University · Not applicable, Interventional, and Treatment
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:
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:
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 140 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the supine position.
Procedure: Supine Percutaneous Nephrolithotomy (PCNL)
Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the conventional prone position.
Procedure: Prone Percutaneous Nephrolithotomy (PCNL)
Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract.
Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract.
Incidence and Severity of Early Postoperative Complications
Complications will be assessed and classified using the Modified Clavien-Dindo Classification system. The scale ranges from Grade I (minor deviation from normal postoperative course) to Grade V (death of the patient). Lower grades indicate a better outcome.
Time frame: Up to 30 days post-surgery
Total Operative Time
Total duration of the surgical procedure, measured continuously from the initial skin incision to the final skin closure, recorded in minutes.
Time frame: Intraoperative (Day 0)
Postoperative Pain Score
Postoperative pain will be evaluated using the Visual Analog Scale. The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate a better outcome (less postoperative pain).
Time frame: At 6 hours, 12 hours, and 24 hours post-surgery
Health-Related Quality of Life (HRQoL)
Measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The utility index score will be calculated using the Kingdom of Saudi Arabia value set, ranging from -0.683 (worst possible health state) to 1.000 (full health), where higher scores indicate a better outcome (better health-related quality of life).
Time frame: At 1 month and 3 months post-surgery
Patient Satisfaction Score
Overall patient satisfaction with the surgical experience, anesthetic process, and early recovery will be measured using a 5-point Likert-type satisfaction scale. The scale ranges from 1 (highly dissatisfied) to 5 (highly satisfied), where higher scores indicate a better outcome (greater patient satisfaction).
Time frame: At 30 days post-surgery
Direct Hospitalization Costs
Total direct medical costs associated with the procedure, calculated as the sum of disposable medical supply costs and hospital stay duration costs. Measured in Yemeni Rials (YER).
Time frame: From hospital admission to hospital discharge (typically 1 to 7 days)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 12 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Sana'a University