Kidney CalculiNCT07627503
Supine vs. Prone PCNL for Large Renal Stones: A Randomized Trial in Yemen.
A study testing Supine Percutaneous Nephrolithotomy (PCNL) and Prone Percutaneous Nephrolithotomy (PCNL) in people with Kidney Calculi and Nephrolithiasis, run by Sana'a University at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Calculi, Nephrolithiasis
- What is being tested?
- Supine Percutaneous Nephrolithotomy (PCNL) and Prone Percutaneous Nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteYemen
- Study dates
- 1 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site
Al-Kuwait University Hospital
Sanaa, 13078
Dr. Waleed M Al-Ata, M.B.B.Ch, +967777775223, Walidalata@gmail.com
About this study
Official 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
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?
Read more
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.
- Conditions
- Kidney Calculi, Nephrolithiasis
- Being tested
- Supine Percutaneous Nephrolithotomy (PCNL), Prone Percutaneous Nephrolithotomy (PCNL)
- Keywords
- PCNL, Percutaneous Nephrolithotomy, Kidney Stones, Supine PCNL, Prone PCNL
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine Percutaneous Nephrolithotomy (PCNL)Procedure or surgery
Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract.
Prone Percutaneous Nephrolithotomy (PCNL)Procedure or surgery
Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract.
| Study group | Role | What they receive |
|---|---|---|
| Supine PCNL | Active comparator | Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the supine position. Receives: Procedure: Supine Percutaneous Nephrolithotomy (PCNL) |
| Prone PCNL | Active comparator | Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the conventional prone position. Receives: Procedure: Prone Percutaneous Nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days post-surgery
Secondary outcomes (5)
Total Operative Time
Total duration of the surgical procedure, measured continuously from the initial skin incision to the final skin closure, recorded in minutes.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From hospital admission to hospital discharge (typically 1 to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mohammed Jowah, Sana'a University
- Investigators
- Waleed M Al-Ata, M.B.B.Ch, Principal investigator, Al-Kuwait University HospitalKhaled M Al-Kohlany, Associate Professor, Study director, Faculty of Medicine and Health Sciences, Sana'a UniversityAbualgaith A Alkholany, MD, Study chair, Al-Kuwait University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627503
- Sponsor's protocol ID
- PCNL-SANA-2026
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07627503
- Acronym / sponsor ID
- PCNL-SANA-2026
- Conditions
- Kidney Calculi, Nephrolithiasis
- Keywords
- PCNL, Percutaneous Nephrolithotomy, Kidney Stones, Supine PCNL, Prone PCNL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine PCNL | Active comparator | Procedure: Supine Percutaneous Nephrolithotomy (PCNL)Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the supine position. |
| Prone PCNL | Active comparator | Procedure: Prone Percutaneous Nephrolithotomy (PCNL)Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the conventional prone position. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine Percutaneous Nephrolithotomy (PCNL)Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract. | Procedure or surgery | Supine PCNL |
| Prone Percutaneous Nephrolithotomy (PCNL)Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract. | Procedure or surgery | Prone PCNL |
Primary outcome
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.
5 secondary outcomes
Total Operative Time
Time frame: Intraoperative (Day 0)
Postoperative Pain Score
Time frame: At 6 hours, 12 hours, and 24 hours post-surgery
Health-Related Quality of Life (HRQoL)
Time frame: At 1 month and 3 months post-surgery
Patient Satisfaction Score
Time frame: At 30 days post-surgery
Direct Hospitalization Costs
Time frame: From hospital admission to hospital discharge (typically 1 to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Waleed M Al-Ata, M.B.B.Ch principal investigator
Al-Kuwait University Hospital
Khaled M Al-Kohlany, Associate Professor study director
Faculty of Medicine and Health Sciences, Sana'a University
Abualgaith A Alkholany, MD study chair
Al-Kuwait University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine Percutaneous Nephrolithotomy (PCNL) and Prone Percutaneous Nephrolithotomy (PCNL) in people with Kidney Calculi and Nephrolithiasis, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haitham M Jowah, Lecturer (+967774831058, h.jowah@su.edu.ye), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Early Postoperative Complications (time frame: Up to 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.