Changes Post Percutaneous Nephrolithotomy (KUB)

December 27, 2023 updated by: Walid Atef Abdulmonem Abdulhafez, Assiut University

Evaluation of Changes of Renal Morphology, Renal Function and Renal Doppler Parameters Post-percutaneous Nephrolithotomy - A Prospective Case Series Study

Using color doppler U/S, Abdominal U/S and radioisotope to evaluate changes of renal morphology, function and doppler parameters post Percutaneous nephrolithotomy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Preoperative assessment:

Detailed history: including history of medical comorbidities, previous history of stone disease or previous treatment of renal stones.

Complete physical examination with measurement and documentation of the pre-operative blood pressure for all patients.

Estimation of body mass index (BMI).

Pre-operative laboratory investigations including:

Complete urine analysis Urine culture and sensitivity test Complete blood picture (CBC). Prothrombin time and prothrombin concentration. Serum urea and creatinine Random blood sugar -Pre-operative imaging investigations: Plain KUB( Number, site, size and radio-opacity of Stones) Abdominal ultrasound ( Dimensions, Shape, borders, contour, orientation & echogenicity, hydronephrosis, stones & others eg. Cysts) Multi-slice computed tomography (MSCT) abdomen and pelvis without contrast. (Dimensions, Shape, borders, contour, orientation, number, site, size, laterality and density of stones) Color Doppler Ultrasonography ( Renal arteries caliber, outline, resistive index, intrarenal arterial waveforms acceleration time& peak systolic velocity) Radioisotope scan (DMSA scan)

-Procedural steps and techniques: Patients with urinary tract infections will be treated with the appropriate antibiotics according to urine culture and sensitivity test until negative culture is obtained.

Percutaneous nephrolithotomy (PCNL) will be performed in prone/supine position under general or spinal anesthesia after insertion of a ureteral catheter to the affected site.

Access will be done under fluoroscopic guidance. Tract dilatation will be done by using either balloon dilator or Amplatz teflon dilators then Amplatz will be inserted.

Stone disintegration after well established track will be done by using either pneumatic or ultrasonic or laser lithotripters.

Stone retrieval will be done by either forceps or Zero-tip dormia basket. At the end of the procedure, plastic tube 22 French may be inserted through the Amplatz sheath as nephrostomy tube or not (tubeless).

Intraoperatively: we record operative time, anaesthesia time, site of renal puncture, puncture relation to last rib, dilatation method, teflon dilatation steps, number of accesses, disintegration methods, use of flexible nephroscope, intraoperative blood transfusion, nephrostomy tube, state of nephrostomy tube when open and perioperative complications.

Post-operative care and follow up:

Plain KUB, abdominal ultrasound, CBC, prothrombin time and concentration & serum creatinine will be done at Day 1 postoperatively.

Measurement of blood pressure at day 1 postoperatively. Abdominal ultrasonography&Color Doppler Ultrasonography at Day 1, Day 7 and Day 90 postoperatively.

Radioisotope scan (DMSA scan) at day 90 postoperatively. Urine analysis

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with renal stones that are candidates for PCNL >18 years old

Description

Inclusion Criteria:

  • Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL.

Exclusion Criteria:

  1. Patients with any previous intervention to extract the renal stones.
  2. Patients with malrotated/anomalous kidney.
  3. Patients with any grade of chronic kidney disease.
  4. Patients with bleeding diathesis.
  5. Patients who are unfit for surgery.
  6. Pregnancy
  7. Patients who are refusing the participation in our study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of renal function post percutaneous nephrolithotomy
Time Frame: 3 months
Radioisotope scan (DMSA scan) Split function in %
3 months
Changes of renal doppler parameters after percutaneous nephrolithotomy.
Time Frame: 3 months
Measured by Resistive Index
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Percutaneous*Nephrolithotomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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