A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses (RALPLPNNX)
17. mars 2021 oppdatert av: Anil Kapoor, St. Joseph's Healthcare Hamilton
A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (<4 cm) amenable to resection using either RALPN or LPN.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
Studietype
Intervensjonell
Registrering (Forventet)
104
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N4A6
- St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
-
-
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
- Patients with SRMs (tumor(s) ≤ 4 cm)
Exclusion Criteria:
- Large tumors > 4.0cm
- Unable to have a general anesthetic
- Unable to comply with post-operative follow-up protocol
- Uncorrectable bleeding diathesis
- Tumors unsuitable for LPN/RALPN technique
- Evidence of metastatic disease
- Prior surgery on the affected kidney
- Ectopic or malrotated kidney
- Mental health condition that precludes informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Laparoscopic Assisted Partial Nephrectomy
Current standard for partial nephrectomies.
|
Robotic (Davinci)
|
|
Aktiv komparator: Robotic Assisted Partial Nephrectomy
Possible new standard for partial nephrectomies.
|
Regular Laparoscopic Technique.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Warm ischemia time
Tidsramme: Duration of the Surgical Procedure (Nephrectomy)
|
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
|
Duration of the Surgical Procedure (Nephrectomy)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
eGFR
Tidsramme: Up to 24 months post operatively.
|
It will be measured preoperatively, postoperatively and at each of the follow-up visit.
|
Up to 24 months post operatively.
|
|
Estimated blood loss
Tidsramme: Duration of the Surgical Procedure (Nephrectomy)
|
Will be measured intraoperatively from the amount of blood (ml) in the suction container.
|
Duration of the Surgical Procedure (Nephrectomy)
|
|
Complication rates as per Clavien-Dindo classification
Tidsramme: Up to 24 months post-operatively.
|
It will be recorded for the intra-operative, post-operative and follow-up period.
|
Up to 24 months post-operatively.
|
|
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
Tidsramme: Duration of the Surgical Procedure
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From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy.
|
Duration of the Surgical Procedure
|
|
Postoperative pain
Tidsramme: Minutes to hours after nephrectomy up to 3 months post-operatively.
|
Minutes to hours after nephrectomy up to 3 months post-operatively.
|
|
|
Length of hospital stay
Tidsramme: 3-7 Days
|
Calculated from day of admission to day of discharge from hospital.
|
3-7 Days
|
|
Positive surgical margin rate
Tidsramme: 14 days
|
Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery.
Distance to surgical margin will be looked at (mm to cm).
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14 days
|
|
Costs of treatment
Tidsramme: Up to 1 year
|
Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St.
Joseph Healthcare case-costing system.
The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care.
The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication.
|
Up to 1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Forventet)
1. desember 2021
Primær fullføring (Forventet)
1. desember 2022
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
10. oktober 2014
Først innsendt som oppfylte QC-kriteriene
12. oktober 2016
Først lagt ut (Anslag)
14. oktober 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RALPLPNNX
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