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

NCT ID: NCT04153474

Last Updated: 2019-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urolithiasis Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Nephrostomy Tube (NT) Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

large-bore nephrostomy tube (LBNT)

large-bore 22 french nephrostomy tube (LBNT)

Group Type ACTIVE_COMPARATOR

large-bore nephrostomy tube (LBNT)

Intervention Type PROCEDURE

large-bore 22 french nephrostomy tube (LBNT)

small-bore nephrostomy tube (SBNT)

small-bore 14 french nephrostomy tube (SBNT)

Group Type ACTIVE_COMPARATOR

small-bore nephrostomy tube (SBNT)

Intervention Type PROCEDURE

small-bore 14 french nephrostomy tube (SBNT)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

large-bore nephrostomy tube (LBNT)

large-bore 22 french nephrostomy tube (LBNT)

Intervention Type PROCEDURE

small-bore nephrostomy tube (SBNT)

small-bore 14 french nephrostomy tube (SBNT)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LBNT SBNT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Staghorn calculi
2. Renal pelvis stones =\>2 cm
3. Lower pole stones= \>1.5 cm
4. upper ureteral calculi =\>1.5 cm
5. SWL-resistant stones

Exclusion Criteria

1. Age \<18 years or Pregnancy
2. Tubeless PNL
3. Need for 3 percutaneous tracts intraoperative
4. Morbid obesity (BMI \>40)
5. Refuse to complete study requirements
6. Tumour in the presumptive access tract area or Potential malignant kidney tumour
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Shoma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SP-LP PCNL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Upper Ureteric Stones
NCT02469766 UNKNOWN PHASE4
Flexible vs Semi-rigid URS
NCT07247617 RECRUITING NA
Management of Medium Sized Renal Stones
NCT06720311 NOT_YET_RECRUITING NA
High Supracostal Versus Subcostal Puncture in Adult PCNL
NCT06350045 ACTIVE_NOT_RECRUITING PHASE4