NCT07097883

Brief Summary

This study compared percutaneous nephrolithotomy (PCNL) complications in cases with or without previous renal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital stay duration

    Lenght of hospital stay was recorded from the admission till the discharge from hospital.

    Till the discharge from hospital (Up to two weeks)

Secondary Outcomes (2)

  • Serum creatinine level

    Preoperatively

  • Incidence of patients who need for auxiliary procedure

    24 hours postoperatively

Study Arms (2)

Fresh cases

Patients with no prior renal surgery.

Procedure: Percutaneous Nephrolithotomy

Recurrent cases

Patients with previous open renal surgery on the same side.

Procedure: Percutaneous Nephrolithotomy

Interventions

Patients underwent percutaneous nephrolithotomy (PCNL) for renal calculi \>2 cm.

Fresh casesRecurrent cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective hospital-based comparative study included 200 patients with recurrent renal stones in one arm and an equal number of patients in a control arm.

You may qualify if:

  • Adult patients (≥18 years).
  • Both sexes.
  • Undergoing percutaneous nephrolithotomy (PCNL) for renal calculi \>2 cm.

You may not qualify if:

  • Active urinary tract infection.
  • Elevated serum creatinine \>2.0 mg/dL.
  • Pregnancy.
  • Uncontrolled coagulopathy.
  • Significant cardiopulmonary comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

MeSH Terms

Interventions

Nephrolithotomy, Percutaneous

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology, Faculty of Medicine, Sohag University, Sohag, Egypt

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

January 1, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations