- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04011865
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
12 luglio 2020 aggiornato da: Binh Dan Hospital
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon.
All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes.
These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
80
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Hoang PC Nguyen, Associate Professor, MD, PhD
- Numero di telefono: +84 913 719 346
- Email: npchoang@gmail.com
Backup dei contatti dello studio
- Nome: Linh NK Tran, MD, PhD
- Numero di telefono: +84 989 047 088
- Email: khaclinh@gmail.com
Luoghi di studio
-
-
-
Ho Chi Minh City, Vietnam, 700000
- Reclutamento
- Binh Dan Hospital
-
Contatto:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Numero di telefono: +84 913 719 346
- Email: npchoang@gmail.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
Inclusion Criteria:
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
Exclusion Criteria:
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Robotic-assisted surgery
|
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
|
Comparatore fittizio: Laparoscopic surgery
|
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The console time
Lasso di tempo: During the surgery
|
The time which surgeon spends on the robot console by minuite
|
During the surgery
|
Mean of blood loss
Lasso di tempo: During the surgery
|
Milliliter
|
During the surgery
|
Perioperative transfusion rate (%)
Lasso di tempo: Up to 1 month after operation
|
The number of cases which will be transfused.
|
Up to 1 month after operation
|
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Lasso di tempo: Up to 1 week after operation
|
Number of cases, based on the result of pathology.
|
Up to 1 week after operation
|
Number of blood units transfused
Lasso di tempo: Up to 1 week after operation
|
Milliliter
|
Up to 1 week after operation
|
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Lasso di tempo: Up to 1 weeks after the surgery.
|
Percentage
|
Up to 1 weeks after the surgery.
|
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
Lasso di tempo: Up to 3 month after surgery
|
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain.
The mean score will be calculated to reflect the post-operative pain.
|
Up to 3 month after surgery
|
Change of hemoglobin from baseline
Lasso di tempo: Up to 1 week after operation
|
(mg/mL)
|
Up to 1 week after operation
|
The drainage time
Lasso di tempo: Up to 3 months after surgery
|
(day),
|
Up to 3 months after surgery
|
To assess urethral catheter time, urethral catheter time
Lasso di tempo: Up to 3 months after surgery
|
(day)
|
Up to 3 months after surgery
|
To assess bowel movement recovery time,
Lasso di tempo: Up to 1 week after surgery
|
(day)
|
Up to 1 week after surgery
|
To assess postoperative hospital stay
Lasso di tempo: Up to 1 month after surgery
|
(day)
|
Up to 1 month after surgery
|
The rate of postoperative complications (including infections)
Lasso di tempo: in day 3, day 7, and 1 month after surgery.
|
Percentage
|
in day 3, day 7, and 1 month after surgery.
|
PSA level in blood
Lasso di tempo: Before operation
|
(mg/mL)
|
Before operation
|
PSA level in blood
Lasso di tempo: 6 weeks post-operation
|
(mg/mL)
|
6 weeks post-operation
|
PSA level in blood
Lasso di tempo: 3 months post-operation
|
(mg/mL)
|
3 months post-operation
|
PSA level in blood
Lasso di tempo: 6 months post-operation
|
(mg/mL)
|
6 months post-operation
|
PSA level in blood
Lasso di tempo: 12 months post-operation
|
(mg/mL)
|
12 months post-operation
|
local and regional recurrences on sonography
Lasso di tempo: through study completion, an average of 1 year
|
including ultrasound when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
|
local and regional recurrences, on MRI
Lasso di tempo: through study completion, an average of 1 year
|
including MRI when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
|
local and regional recurrences, on PET Scan
Lasso di tempo: through study completion, an average of 1 year
|
including PET Scan, when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Lasso di tempo: Preoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
Preoperative
|
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
Lasso di tempo: 3 months postoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
3 months postoperative
|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Lasso di tempo: 6 months, postoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
6 months, postoperative
|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Lasso di tempo: 12 months postoperative.
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
12 months postoperative.
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Lasso di tempo: Preoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
Preoperative
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Lasso di tempo: 3 months, postoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
3 months, postoperative
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Lasso di tempo: 6 months, postoperative.
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
6 months, postoperative.
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Lasso di tempo: 12 months postoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
12 months postoperative
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Lasso di tempo: Preoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
Preoperative
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Lasso di tempo: 3 months, postoperative.
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
3 months, postoperative.
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Lasso di tempo: 6 months, postoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
6 months, postoperative
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Lasso di tempo: 12 months postoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
12 months postoperative
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Hung V Tran, MD, PhD, Binh Dan Hospital
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2019
Completamento primario (Anticipato)
31 dicembre 2020
Completamento dello studio (Anticipato)
31 dicembre 2020
Date di iscrizione allo studio
Primo inviato
13 maggio 2019
Primo inviato che soddisfa i criteri di controllo qualità
4 luglio 2019
Primo Inserito (Effettivo)
9 luglio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 luglio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 luglio 2020
Ultimo verificato
1 luglio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BD022019
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro alla prostata
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutanteStadio III Adenocarcinoma della prostata AJCC v7 | Stadio II Adenocarcinoma prostatico AJCC v7 | Fase I Adenocarcinoma della prostata American Joint Committee on Cancer (AJCC) v7Stati Uniti
Prove cliniche su Radical prostatectomy
-
Trakya UniversityCompletatoIndice di perfusione | Ventilazione a un polmone | Ipossiemia durante l'intervento chirurgico | Indice di riserva di ossigeno | Indice di variabilità pletismograficaTacchino
-
Johannes Gutenberg University MainzCompletato
-
University of ChicagoRitirato
-
Pamela PetersenCompletato
-
Cairo UniversityAbdelhamid, Bassant Mohamed, M.D.; Mohamed, Ahmed A., M.D.; Ashraf Mohamed Abd... e altri collaboratoriCompletatoMasimo Radical Pulse Co-ossimetro nella pratica della trasfusione di sangue intraoperatoria durante la procedura obestatricaEgitto
-
Zonguldak Bulent Ecevit UniversityCompletatoFlusso fresco | CarbossiemoglobinemiaTacchino
-
George Washington UniversityAttivo, non reclutante
-
Hopital FochCompletato
-
Antalya Training and Research HospitalCompletatoComplicanze del taglio cesareoTacchino
-
Kasr El Aini HospitalSconosciuto