Sammenligning av stentrelaterte symptomer: Regelmessig dobbel j-stent kontra comfi j stent (COMFIJ)
Sammenligning av stentrelaterte symptomer mellom vanlig dobbel j stent kontra comfi j stent: en enkelt blindet randomisert kontrollert studie
A prospective, single-blinded, randomized controlled trial conducted at a single center to compare stent related symptoms between two different stents using Ureteral Stent Symptom Questionnaire (USSQ) scores , Visual Analog Scale (VAS) pain scores.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Ureteral stents are widely used in urology following retrograde intrarenal surgeries and ureteric lithotripsy and other endourological procedures. However, their use is associated with significant discomfort, infections, and reduced quality of life (QoL). Over time, different materials and designs have been developed to improve stent performance and reduce complications. This study aims to compare the stent-related symptoms (SRS) of two types of ureteral stents: the regular Double J stent and the Comfi J stent.
Objectives of the study-
- Compare Ureteral Stent Symptom Questionnaire (USSQ) scores between the two stents.
- Compare Visual Analog Scale (VAS) pain scores.
- Assess complications associated with each stent.
- Evaluate the difficulty of stent insertion.
Study Design & Methods: A prospective, single-blinded, randomized controlled trial conducted at a single center. Sample Size: 100 patients undergoing retrograde intrarenal surgery, ureteroscopic lithotripsy
Randomization: Intraoperative, using a computer-generated sequence, block randomization Assessments: USSQ and VAS scores at post-operative days (POD) 1, 7, and 14.
Statistical Analysis: Statistical Package for the Social Sciences software with a significance threshold of p < 0.05.
Expected Outcomes: Determining whether the Comfi J stent reduces pain, urinary symptoms, and other complications compared to the regular Double J stent.
Evaluating if changes in design/material can improve patient QoL.
Ethical Considerations:
Institutional ethics approval and informed consent from all participants. Confidentiality ensured, with voluntary participation.
This study aims to provide evidence-based recommendations for improving ureteral stent tolerability and reducing patient morbidity
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Bagmati
-
Kathmandu, Bagmati, Nepal, 44600
- Bir Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Eligible participants were adult patients (aged 18-80 years) who underwent unilateral retrograde ureteroscopy (URS) lithotripsy for stone disease
- Retrograde intrarenal surgery (RIRS) lithotripsy with planned ureteric stent insertion for urinary tract stones
Exclusion Criteria:
- Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- Neurogenic bladder, Overactive bladder syndrome, and neurological and psychiatric diseases
- Preoperative febrile Urinary Tract Infection (UTI)
- Pregnancy or breastfeeding;
- A single kidney
- Moderate or severe cardiovascular or cerebrovascular disease
- Hepatic dysfunction
- History of pelvic surgery or irradiation
- History of bladder or prostate surgery
- Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the USSQ pain score
- Allergy to any medication
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Regular Double J stent
Regular Double J stent placement |
Regular Double J stent |
|
Aktiv komparator: Comfi J stent
Comfi J stent placement |
Comfi J stent |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stent related symptom
Tidsramme: 2 weeks
|
Comparison of Ureteral Stent Symptom Questionnaire (USSQ) scores between regular Double J stent and Comfi J stent at postoperative day 1, 7, and 14. Higher Scores means greater severity of the symptoms. |
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Complication rates
Tidsramme: before 2 weeks
|
Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms. |
before 2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ComfiJ
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