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

NCT07627503 | Not Yet Recruiting

• 1 other identifier: PCNL-SANA-2026
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi; Nephrolithiasis

Keywords

PCNL; Percutaneous Nephrolithotomy; Kidney Stones; Supine PCNL; Prone PCNL

Outcome Measures

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.

  Up to 30 days post-surgery

Secondary Outcomes (5)

• Total Operative Time

  Intraoperative (Day 0)

• Postoperative Pain Score

  At 6 hours, 12 hours, and 24 hours post-surgery

• Health-Related Quality of Life (HRQoL)

  At 1 month and 3 months post-surgery

• Patient Satisfaction Score

  At 30 days post-surgery

• Direct Hospitalization Costs

  From hospital admission to hospital discharge (typically 1 to 7 days)

Study Arms (2)

Supine PCNL

ACTIVE COMPARATOR

Patients will undergo standard percutaneous nephrolithotomy (24-30 Fr tract size) performed in the supine position.

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.

Procedure: Prone Percutaneous Nephrolithotomy (PCNL)

Interventions

Supine Percutaneous Nephrolithotomy (PCNL) PROCEDURE

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

Supine PCNL

Prone Percutaneous Nephrolithotomy (PCNL) PROCEDURE

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

Prone PCNL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Al-Kuwait University Hospital

Sanaa, 13078, Yemen

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

• Abualgaith A Alkholany, MD

  Al-Kuwait University Hospital

  STUDY CHAIR

Central Study Contacts

Haitham M Jowah, Lecturer

CONTACT

+967774831058; h.jowah@su.edu.ye

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

CONTACT

+967777775223; Walidalata@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)