Kidney Calculi, Nephrolithiasis
Conditions
Keywords
PCNL, Percutaneous Nephrolithotomy, Kidney Stones, Supine PCNL, Prone PCNL
Brief summary
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.
Interventions
PROCEDURESupine Percutaneous Nephrolithotomy (PCNL)
Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract.
PROCEDUREProne Percutaneous Nephrolithotomy (PCNL)
Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract.
Sponsors
Sana'a University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Early Postoperative Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Operative Time | Intraoperative (Day 0) | Total duration of the surgical procedure, measured continuously from the initial skin incision to the final skin closure, recorded in minutes. |
| Postoperative Pain Score | 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). |
| Health-Related Quality of Life (HRQoL) | 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). |
| Patient Satisfaction Score | 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). |
| Direct Hospitalization Costs | 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). |
Countries
Yemen
Contacts
CONTACTHaitham M Jowah, Lecturer
CONTACTWaleed M Al-Ata, M.B.B.Ch
PRINCIPAL_INVESTIGATORWaleed M Al-Ata, M.B.B.Ch
Al-Kuwait University Hospital
STUDY_DIRECTORKhaled M Al-Kohlany, Associate Professor
Faculty of Medicine and Health Sciences, Sana'a University
STUDY_CHAIRAbualgaith A Alkholany, MD
Al-Kuwait University Hospital
Outcome results
None listed