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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine PCNL | Active Comparator | Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the supine position. |
|
| Prone PCNL | Active Comparator | Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the conventional prone position. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supine Percutaneous Nephrolithotomy (PCNL) | Procedure | Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Operative Time | Total duration of the surgical procedure, measured continuously from the initial skin incision to the final skin closure, recorded in minutes. | Intraoperative (Day 0) |
| Postoperative Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haitham M Jowah, Lecturer | Contact | +967774831058 | h.jowah@su.edu.ye | |
| Waleed M Al-Ata, M.B.B.Ch | Contact | +967777775223 | Walidalata@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Waleed M Al-Ata, M.B.B.Ch | Al-Kuwait University Hospital | Principal Investigator |
| Khaled M Al-Kohlany, Associate Professor | Faculty of Medicine and Health Sciences, Sana'a University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Kuwait University Hospital | Sanaa | 13078 | Yemen |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Prone Percutaneous Nephrolithotomy (PCNL) | Procedure | Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract. |
|
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).
| 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). | 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). | 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). | From hospital admission to hospital discharge (typically 1 to 7 days) |
| Abualgaith A Alkholany, MD | Al-Kuwait University Hospital | Study Chair |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |