Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
12. juli 2020 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ho Chi Minh City, Vietnam, 700000
- Rekruttering
- Binh Dan Hospital
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Kontakt:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Telefonnummer: +84 913 719 346
- E-mail: npchoang@gmail.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Robotic-assisted surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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Sham-komparator: Laparoscopic surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The console time
Tidsramme: During the surgery
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The time which surgeon spends on the robot console by minuite
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During the surgery
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Mean of blood loss
Tidsramme: During the surgery
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Milliliter
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During the surgery
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Perioperative transfusion rate (%)
Tidsramme: Up to 1 month after operation
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The number of cases which will be transfused.
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Up to 1 month after operation
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The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Tidsramme: Up to 1 week after operation
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Number of cases, based on the result of pathology.
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Up to 1 week after operation
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Number of blood units transfused
Tidsramme: Up to 1 week after operation
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Milliliter
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Up to 1 week after operation
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the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Tidsramme: Up to 1 weeks after the surgery.
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Percentage
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Up to 1 weeks after the surgery.
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The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
Tidsramme: Up to 3 month after surgery
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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.
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Up to 3 month after surgery
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Change of hemoglobin from baseline
Tidsramme: Up to 1 week after operation
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(mg/mL)
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Up to 1 week after operation
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The drainage time
Tidsramme: Up to 3 months after surgery
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(day),
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Up to 3 months after surgery
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To assess urethral catheter time, urethral catheter time
Tidsramme: Up to 3 months after surgery
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(day)
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Up to 3 months after surgery
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To assess bowel movement recovery time,
Tidsramme: Up to 1 week after surgery
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(day)
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Up to 1 week after surgery
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To assess postoperative hospital stay
Tidsramme: Up to 1 month after surgery
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(day)
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Up to 1 month after surgery
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The rate of postoperative complications (including infections)
Tidsramme: in day 3, day 7, and 1 month after surgery.
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Percentage
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in day 3, day 7, and 1 month after surgery.
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PSA level in blood
Tidsramme: Before operation
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(mg/mL)
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Before operation
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PSA level in blood
Tidsramme: 6 weeks post-operation
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(mg/mL)
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6 weeks post-operation
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PSA level in blood
Tidsramme: 3 months post-operation
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(mg/mL)
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3 months post-operation
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PSA level in blood
Tidsramme: 6 months post-operation
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(mg/mL)
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6 months post-operation
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PSA level in blood
Tidsramme: 12 months post-operation
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(mg/mL)
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12 months post-operation
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local and regional recurrences on sonography
Tidsramme: through study completion, an average of 1 year
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including ultrasound when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on MRI
Tidsramme: through study completion, an average of 1 year
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including MRI when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on PET Scan
Tidsramme: through study completion, an average of 1 year
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including PET Scan, when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Tidsramme: Preoperative
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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.
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Preoperative
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Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
Tidsramme: 3 months postoperative
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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.
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3 months postoperative
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Tidsramme: 6 months, postoperative
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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.
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6 months, postoperative
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Tidsramme: 12 months postoperative.
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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.
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12 months postoperative.
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Tidsramme: Preoperative
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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.
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Preoperative
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Tidsramme: 3 months, postoperative
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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.
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3 months, postoperative
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Tidsramme: 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.
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6 months, postoperative.
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Tidsramme: 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.
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12 months postoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Tidsramme: Preoperative
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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.
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Preoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Tidsramme: 3 months, postoperative.
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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.
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3 months, postoperative.
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Tidsramme: 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.
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6 months, postoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Tidsramme: 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.
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12 months postoperative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Hung V Tran, MD, PhD, Binh Dan Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2019
Primær færdiggørelse (Forventet)
31. december 2020
Studieafslutning (Forventet)
31. december 2020
Datoer for studieregistrering
Først indsendt
13. maj 2019
Først indsendt, der opfyldte QC-kriterier
4. juli 2019
Først opslået (Faktiske)
9. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BD022019
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