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NCT Number: NCT07627503

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

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Willingness and ability to provide informed consent.

Exclusion criteria

  • 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.
  • Patients with severe cardiopulmonary disease where general anesthesia or prolonged surgical positioning is contraindicated.
  • Patients with a history of previous ipsilateral renal surgery.
  • Patients unwilling or unable to comply with follow-up protocols.

Treatment and study plan

Supine Percutaneous Nephrolithotomy (PCNL)

Procedure

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

Prone Percutaneous Nephrolithotomy (PCNL)

Procedure

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

Primary outcomes

  1. Incidence and Severity of Early Postoperative Complications

    Time frame: Up to 30 days post-surgery

    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.

Secondary outcomes

  1. Total Operative Time

    Time frame: Intraoperative (Day 0)

    Total duration of the surgical procedure, measured continuously from the initial skin incision to the final skin closure, recorded in minutes.

  2. Postoperative Pain Score

    Time frame: At 6 hours, 12 hours, and 24 hours post-surgery

    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).

  3. Health-Related Quality of Life (HRQoL)

    Time frame: At 1 month and 3 months post-surgery

    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).

  4. Patient Satisfaction Score

    Time frame: At 30 days post-surgery

    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).

  5. Direct Hospitalization Costs

    Time frame: From hospital admission to hospital discharge (typically 1 to 7 days)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Haitham M Jowah, Lecturer

CONTACT

[email protected]

+967774831058

Waleed M Al-Ata, M.B.B.Ch

CONTACT

[email protected]

+967777775223

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

Comparative Evaluation of Early Postoperative Complications, Cost-Effectiveness, and Patient-Centered Outcomes Following Supine and Prone Standard Percutaneous Nephrolithotomy (PCNL): A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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