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UrolithiasisNCT04153474

Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?

A study testing large-bore nephrostomy tube (LBNT) and small-bore nephrostomy tube (SBNT) in people with Urolithiasis and Nephrolithotomy, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
large-bore nephrostomy tube (LBNT) and small-bore nephrostomy tube (SBNT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteEgypt
Study dates
1 May 2019to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Staghorn calculi
  • Renal pelvis stones =>2 cm
  • Lower pole stones= >1.5 cm
  • upper ureteral calculi =>1.5 cm
  • SWL-resistant stones

Who cannot join

  • Age <18 years or Pregnancy
  • Tubeless PNL
  • Need for 3 percutaneous tracts intraoperative
  • Morbid obesity (BMI >40)
  • Refuse to complete study requirements
  • Tumour in the presumptive access tract area or Potential malignant kidney tumour

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Urology and Nephrology Center

    Al Mansurah, Aldakahlia, 35516

Other trials in Egypt

About this study

Official title: Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial

Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (~75% in USA and Canada) and toward LB NT in South America (~80% in Argentina and Mexico). In Europe the trend is equal (~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL.

Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications

Being tested
large-bore nephrostomy tube (LBNT), small-bore nephrostomy tube (SBNT)
Keywords
Percutaneous nephrolithotomy (PNL), Nephrostomy tube (NT), Pain, Patient satisfaction
Medical subject headings
Urolithiasis, Pain, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • large-bore nephrostomy tube (LBNT)Procedure or surgery

    Also called LBNT

    large-bore 22 french nephrostomy tube (LBNT)

  • small-bore nephrostomy tube (SBNT)Procedure or surgery

    Also called SBNT

    small-bore 14 french nephrostomy tube (SBNT)

Study groups in NCT04153474
Study groupRoleWhat they receive
large-bore nephrostomy tube (LBNT)Active comparatorlarge-bore 22 french nephrostomy tube (LBNT)
Receives: Procedure: large-bore nephrostomy tube (LBNT)
small-bore nephrostomy tube (SBNT)Active comparatorsmall-bore 14 french nephrostomy tube (SBNT)
Receives: Procedure: small-bore nephrostomy tube (SBNT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of hemoglobin reduction difference between groups

    measured in gram/liter

    Measured: 8 months

Secondary outcomes (3)

  1. postoperative pain score

    Assessed by Visual Analogue Scale (VAS) points from 0 to 10

    Measured: 8 months

  2. postoperative patient satisfaction

    measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6

    Measured: 8 months

  3. overall postoperative complication

    assesed by Clavien-Dindo system

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start1 May 2019
  3. Primary completion1 Feb 2020 (estimated)
  4. Study completion1 Feb 2020 (estimated)

Resources

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
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04153474
Sponsor's protocol ID
SP-LP PCNL
Status last verified
Oct 2019
First submitted
4 Nov 2019
Last updated
6 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing large-bore nephrostomy tube (LBNT) and small-bore nephrostomy tube (SBNT) in people with Urolithiasis and Nephrolithotomy, run by Mansoura University at 1 site in Egypt.

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 6 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: status not confirmed, as of the sponsor's last update on 6 Nov 2019. 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 Egypt. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of hemoglobin reduction difference between groups (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04153474.

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 6 Nov 2019.

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