- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01437904
A Pilot Study Assessing The Feasibility Of Outpatient Tubeless Percutaneous Nephrolithotomy (PCNL)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
One in eight human beings will develop kidney stones during their lifetime. Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical operation for the removal of large kidney stones. Around the world, patients are routinely admitted to hospital following PCNL. The reasons that outpatient PCNL has not been otherwise attempted are related to the risk of bleeding and the need for an indwelling kidney drainage tube. Other than a single publication from the mid-1980's, there have been no other publications regarding outpatient PCNL up until this year, both from our group at Queen's University. We challenge the need for hospitalization following PCNL provided that proper technique for percutaneous renal access is used and patients are very carefully selected. In fact, we have safely performed outpatient tubeless PCNL on over 5 patients to date and we have two related published abstracts that were presented in 2008 at international Urology conferences in Albuquerque, New Mexico and Shanghai, China. Our manuscript titled "Totally tubeless outpatient percutaneous nephrolithotomy: initial case report" has been published in Advances in Urology in 2009. Additionally, a second manuscript of ours titled "Outpatient tubeless PCNL: the initial case series" is currently in press in the Canadian Urological Association Journal.
Outpatient PCNL offers patients several potential benefits, including decreased pain due to lack of nephrostomy tube, earlier and faster convalescence and lower rate of hospital acquired infections and complications. Furthermore, outpatient PCNL may offer several potential cost savings to the hospital and health care system, including the daily cost of an inpatient hospital bed, the imaging and procedural costs of antegrade nephrostogram, including the interventional radiologist's fee, the cost of nursing staff and the cost of intravenous antibiotics and other medications required by the hospitalized patient. Conversely, outpatient PCNL could potentially result in additional costs if emergency visits, readmissions and further interventions occur.
Project Synopsis This project is a pilot study that examines the safety, efficacy, feasibility and potential cost savings of performing percutaneous nephrolithotomy (PCNL) on an outpatient basis. If shown to be feasible, outpatient PCNL could result in significant potential cost savings to the hospital and health care system, as normal care following PCNL involves a 1-3 day hospital stay. The main objective of this pilot study is to obtain preliminary data necessary to develop a definitive national multicentre prospective randomized controlled trial comparing outpatient PCNL to standard PCNL.
Hypotheses Patients can be successfully randomized to outpatient versus standard PCNL and that outpatient PCNL will be a successful procedure.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Centre for Applied Urological Research/Kingston General Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- scheduled for Percutaneous nephrolithotomy (PCNL) of renal calculi
- patient has normal renal function
- patient is 18 or older
- patient agrees to return for follow up
- ASA class 1 or 2
Exclusion Criteria:
- patient has had previous PCNL for same stone
- patient is pregnant
- patient would not be appropriate as participant (investigator's opinion)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Outpatient
Outpatient recovery following Percutaneous nephrolithotomy
|
Patients go home following Percutaneous nephrolithotomy
|
|
Comparatore fittizio: In hospital
Inpatient recovery following Percutaneous nephrolithotomy
|
Patients are hospitalized following Percutaneous nephrolithotomy
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.
Lasso di tempo: One month
|
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.
|
One month
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Is there is a difference in costs, complications and stone-free rates between the two groups.
Lasso di tempo: One month
|
Is there a difference in costs, complications and stone-free rates between the two groups.
|
One month
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Darren Beiko, MD FRCSC, Queen's University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PCNL Beiko
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Calcoli renali
-
National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
-
National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
Prove cliniche su Outpatient Recovery
-
Recovery Record ResearchStanford UniversityCompletatoBulimia nervosa | Problemi alimentari | Disturbo da alimentazione incontrollataStati Uniti
-
Tilburg UniversityStichting tot steun VCVGZ; Trimbos-institute (also primary organization conducting... e altri collaboratoriCompletatoGrave malattia mentale | Vulnerabilità mentaliOlanda
-
Hangzhou Normal UniversityCompletatoDisturbo della coscienza | Stato di minima coscienzaCina
-
Bright TherapeuticsCommunity Medical ServicesCompletato
-
Yale UniversityTerminatoQualità della vita | Schizofrenia | Aderenza ai farmaci | Segni e sintomi | Adattamento, psicologicoStati Uniti
-
BDH-Klinik Hessisch OldendorfReclutamentoIctus | Trauma cranico | Disturbo neurologico | Disturbo della coscienza | Encefalopatia ipossico-ischemicaGermania
-
Grupo Español de Rehabilitación MultimodalInstituto de Salud Carlos III; Instituto de Investigación Sanitaria AragónReclutamentoChirurgia MaggioreSpagna
-
Duke UniversityCompletato
-
Fudan UniversitySconosciuto
-
IRCCS Centro San Giovanni di Dio FatebenefratelliReclutamentoGrave disturbo mentale | Grave malattia mentaleItalia