Health Trials

Supine vs. Prone PCNL for Large Renal Stones: A Randomized Trial in Yemen.

ConditionsKidney CalculiNephrolithiasis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Supine Percutaneous Nephrolithotomy (PCNL)

    Procedure/Surgery

    Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract.

  • Prone Percutaneous Nephrolithotomy (PCNL)

    Procedure/Surgery

    Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Supine PCNLActive comparator 1 intervention
Group B: Prone PCNLActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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)
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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

Sana'a University

Lead sponsor

Source ClinicalTrials.gov

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