Ureteral Stent Size Measurement Study
30. juli 2015 oppdatert av: Samuel Deem, DO, CAMC Health System
Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?
To examine a patient's quality of life using three methods for measuring stent size: (a) direct measurement, (b) patient height, and (c) a standardized formula.
The intent of the study is to show if there is a difference in a patient's quality of life, postoperative symptoms, pain medication and anticholinergic use by using one of these specific methods for stent size determination.
No method is interventional in this study.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Ureteral stent placement is common in Urologic practice and many studies have been done looking at factors to improve stent related symptoms, but few have used a validated questionnaire to assess these symptoms affect on quality of life.We plan to prospectively randomize patients to three separate techniques such as (a) direct measurement,(b) patient height, and (c) a standardized formula for the determination of stent size.
Using a validated questionnaire, the Ureteral Stent Symptoms Questionnaire (USSQ), we will assess whether there is a difference in outcome measures such as patient quality of life, need for pain medications and anticholinergics, and in postoperative symptoms based on one of these techniques.
The USSQ was developed by Joshi et al to assess the impact of health-related quality of life issues related to ureteral stents.
Data from USSQ questionnaire will be collected 7-10 days post-operatively as well as 4 weeks post-op and then this will be aggregated for our outcome measures to determine which method of stent size give better outcomes.
Studietype
Observasjonsmessig
Registrering (Faktiske)
17
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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West Virginia
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Charleston, West Virginia, Forente stater, 25301
- Urology center of charleston
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Community patients who present to Charleston area Medical Center (CAMC) or the private urology clinics of Drs.
Davalos,Martinez,Tierney with the requirement of ureteral stent would be screened for possible enrillment in the study.
Beskrivelse
Inclusion Criteria:
- All patients presenting to Charleston Area Medical Center between the ages of 18 and 90 years old who will undergo cytoscopy or ureteroscopy with ureteral stent placement will be eligible for the study.
Exclusion Criteria:
- Patients excluded from this study will be those who are less than 18 years of age, pregnant women, and patients who are septic on presentation, as well as patients who have had lower extremity amputations or are wheelchair bound.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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1 Direct ureteric measurement
This is determined by using a 5 French Pollack Open-Ended Flexi-Tip Ureteral catheter (Cook, Spencer, Indiana) to cannulate the ureteral orifice.
A retrograde pyelogram will be done at the conclusion of the procedure and the Pollack will be advanced to the pyeloureteral junction (PUJ) under fluoroscopy.
At this point the length of the distance between the PUJ and vesicoureteral junction (VUJ) will be recorded and stent length determined based on this measurement.
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2 Based on patient height
We will use the height measurement criteria used by Lee et al in their study.
Patients less than 5'2" will receive a 22 cm stent, 5'3"-5'7" will get a 24 cm stent, 5'8"-5'10" will get a 26 cm stent, 5'11" to 6'1" will get a 28 cm stent, and all patients greater than 6'2" will receive a 30 cm stent.
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3 Based on a predetermined formula
We will use the formula described by Wieder.
Stent length in cm= patients height in inches - 42.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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To determine the difference in patient quality of life (QOL), post-op symptoms, and pain medication and anticholinergic use in patients who receive ureteral stents where size is determined by direct measurement, patient height,a standardized formula.
Tidsramme: within 4 weeks post-porcedure
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within 4 weeks post-porcedure
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Samuel Deem, M.D., CAMC Medical Staff - with admitting privileges
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2009
Primær fullføring (Faktiske)
1. mai 2014
Studiet fullført (Faktiske)
1. mai 2014
Datoer for studieregistrering
Først innsendt
15. mai 2009
Først innsendt som oppfylte QC-kriteriene
11. juni 2009
Først lagt ut (Anslag)
12. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
31. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2015
Sist bekreftet
1. juli 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 09-03-2137
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