Conventional PCNL Versus Tubeless PCNL

NCT ID: NCT03907930

Last Updated: 2019-04-09

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2020-05-31

Brief Summary

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prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL

Detailed Description

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Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications.

Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.

This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate

Conditions

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Percutaneous Nephrolithotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group of patients will be submitted for conventional PCNL other group will be submitted to tubeless PCNL
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
triple blinded study

Study Groups

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conventional

this arm will have both nephrostomy tube and ureteric catheter after completing the operation

Group Type ACTIVE_COMPARATOR

percutaneous nephrolithotripsy

Intervention Type PROCEDURE

removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast

tubeless

the arm will have only ureteric catheter rafter completing the operation

Group Type ACTIVE_COMPARATOR

percutaneous nephrolithotripsy

Intervention Type PROCEDURE

removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast

Interventions

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percutaneous nephrolithotripsy

removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast

Intervention Type PROCEDURE

Other Intervention Names

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PCNL

Eligibility Criteria

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Inclusion Criteria

* Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure

Exclusion Criteria

1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.

3\. Complex or staghorn stones requiring staged procedure.

Intra operative criteria:

4\. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Alsayed Ahmed Zowita

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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atef abd aziz, professor

Role: STUDY_CHAIR

assuit university hospital urology departement egypt

Locations

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Assuit University Hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed zowita, doctor

Role: CONTACT

01006769102

mahmoud shalaby, professor

Role: CONTACT

01111222203

Facility Contacts

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mohamed zowita, doctor

Role: primary

01006769102

References

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Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.

Reference Type BACKGROUND
PMID: 1006190 (View on PubMed)

Valdivia Uria JG, Valle Gerhold J, Lopez Lopez JA, Villarroya Rodriguez S, Ambroj Navarro C, Ramirez Fabian M, Rodriguez Bazalo JM, Sanchez Elipe MA. Technique and complications of percutaneous nephroscopy: experience with 557 patients in the supine position. J Urol. 1998 Dec;160(6 Pt 1):1975-8. doi: 10.1016/s0022-5347(01)62217-1.

Reference Type BACKGROUND
PMID: 9817303 (View on PubMed)

Other Identifiers

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tubeless PCNL

Identifier Type: -

Identifier Source: org_study_id

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