- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03206515
The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones
29. juni 2017 opdateret af: Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones: A Randomized Controlled Trial
Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of >20mm kidney stones.
Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications.
At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on.
But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness.
Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of >20mm kidney stones.
Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications.
At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on.
But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness.
Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
86
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Guangming Chen
- Telefonnummer: +8613246888213
- E-mail: 1172676107@qq.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510230
- Rekruttering
- epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients consent for percutaneous renal stone removal
- Age 18 to 70 years
- Normal renal function
- ASA score Ⅰ and Ⅱ
- Renal stones 20-50mm
Exclusion Criteria:
- Patients with solitary kidney
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- Morbid obese patients
- Patients who underwent transplant or urinary diversion
- Congenital abnormalities
- Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Group 1
Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group
|
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
|
Andet: Group 2
Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group
|
Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The renal pelvic pressure
Tidsramme: During the procedure
|
To measure the renal pelvic pressure during mini-PCNL procedure
|
During the procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Perioperative complications
Tidsramme: Intraoperatively or ≤ 1 month postoperatively
|
Invaluate perioperative complications by modified Clavien system
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Intraoperatively or ≤ 1 month postoperatively
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Forventet)
1. december 2017
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
27. oktober 2016
Først indsendt, der opfyldte QC-kriterier
29. juni 2017
Først opslået (Faktiske)
2. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MRER(17)2016
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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