- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07725653
Impact of Anterior Urethral Suspension Combined With Pelvic Fascia Reconstruction During Robot-Assisted Radical Prostatectomy on Early Postoperative Urinary Continence Recovery: A Single-Center, Prospective, Single-Arm Clinical Study (IAPREA)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Beijing, Kina
- Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
1. Pathologically confirmed prostate cancer;
2. Scheduled to undergo modified robot-assisted radical prostatectomy;
3. Able to complete regular postoperative follow-up and functional assessment;
4. Voluntarily sign written informed consent.
Exclusion Criteria:
1. Previous history of pelvic radiotherapy or prostate surgery;
2. Severe cardiac, pulmonary, cerebrovascular, hepatic or renal dysfunction that cannot tolerate general anesthesia and surgery;
3. Neurogenic bladder or severe preoperative urinary incontinence;
4. Cognitive impairment making follow-up assessment impossible.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Modified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction
This single-arm group receives modified robot-assisted radical prostatectomy (RARP).
The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery.
All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.
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This single-arm group receives modified robot-assisted radical prostatectomy (RARP).
The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery.
All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Early urinanry continence recovery rate
Tidsramme: 3 consecutive months postoperatively
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Urinary continence is defined as the use of no more than one absorbent pad within 24 hours.
The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
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3 consecutive months postoperatively
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Urinary continence recovery rate
Tidsramme: 3 consecutive months postoperatively
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Urinary continence is defined as the use of no more than one absorbent pad within 24 hours.
The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery.
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3 consecutive months postoperatively
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Samarbeidspartnere og etterforskere
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCC6160
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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