An interventional study of En bloc TURBT Collins Loop and Conventional TURBT in Bladder Cancer, Bladder Neoplasm and Bladder Urothelial Carcinoma, sponsored by Hospital Universitario de Fuenlabrada. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Hospital Universitario de Fuenlabrada · Not applicable, Interventional, and Treatment
This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.
The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.
The secondary objetives are:
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 80 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Hospital Universitario de Fuenlabrada is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy. After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected.
Device: En bloc TURBT Collins Loop
The TURB will be carried out with bipolar current according to the traditional technique.
Device: Conventional TURBT
En bloc TURBT Collins Loop
Conventional TURBT
presence of detrusor muscle in the resected sample
yes/no
Time frame: 1 year of follow up
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Hospital Universitario de Fuenlabrada