ProstatectomyNCT06020287
The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach
An observational study of Prostatectomy and Prostate Neoplasm, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
The goal of this observational study was to compare the perioperative outcomes, postoperative urinary control rates and positive surgical margin (PSM) rates of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with the Retzius-sparing approach (RS-RARP) and… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatectomy, Prostate Neoplasm
- What is being tested?
- the robot-assisted laparoscopic radical prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 233 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 27 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The clinical data of 233 patients treated between September 2020 and May 2022 at Nanjing Drum Tower Hospital were retrospectively analyzed.
Who may be able to join
- pathologically diagnosed with prostate cancer by prostate biopsy
- underwent robot-assisted laparoscopic surgery
- the surgery performed by Weidong Gan
- the extended pelvic lymphadenectomy (PLA) is performed on patients with high-risk prostate cancer (PSA≥20 ng/ml or Grade Group 4-5 or clinical stage ≥T2c) and those considered to have a possibility of lymph node metastasis based on imaging evaluation.
Who cannot join
- Patients with a clinical and pathological TNM stage ≥T3b and N1
- patients with distant metastasis
- urinary incontinence before surgery
- received neoadjuvant therapy before surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: The Early Therapeutic Efficacy of The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach: A Single-Center Retrospective Cohort Study
The goal of this observational study was to compare the perioperative outcomes, postoperative urinary control rates and positive surgical margin (PSM) rates of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment of prostate cancer. The main question it aims to answer was:
- The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach
Read more
Participants has been underwent:
- AP-RARP
- RS-RARP
- anterior-RARP Researchers compared the three groups to see if AP-RARP combines the advantages of anterior and posterior RARP and is a feasible surgical option for the treatment of prostate cancer.
- Conditions
- Prostatectomy, Prostate Neoplasm
- Being tested
- the robot-assisted laparoscopic radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the robot-assisted laparoscopic radical prostatectomyProcedure or surgery
We collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared.
| Study group | Role | What they receive |
|---|---|---|
| AP-RARP | the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach Receives: Procedure: the robot-assisted laparoscopic radical prostatectomy | |
| RS-RARP | the robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach Receives: Procedure: the robot-assisted laparoscopic radical prostatectomy | |
| anterior-RARP | he robot-assisted laparoscopic radical prostatectomy with anterior approach Receives: Procedure: the robot-assisted laparoscopic radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary continence
was defined as using 0-1 pad a day
Measured: 0-6 month after surgery
positive surgical margin
observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist
Measured: 2 weeks after surgery
Secondary outcomes (2)
operating time
The start time of the operation refers to the time of incision of the skin at the surgical site. The end time of surgery refers to the time when the skin is sutured.
Measured: the day of the surgery
intraoperative blood loss
Intraoperative bleeding was defined as the sum of blood content in blood gauze, blood content in negative pressure suction bottle and blood clot volume.
Measured: the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2020
- Primary completion31 May 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Feng, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020287
- Sponsor's protocol ID
- NanjingUSM202388
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Therapeutic Efficacy of The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach: A Single-Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06020287
- Acronym / sponsor ID
- NanjingUSM202388
- Conditions
- Prostatectomy, Prostate Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study was to compare the perioperative outcomes, postoperative urinary control rates and positive surgical margin (PSM) rates of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment of prostate cancer. The main question it aims to answer was:
- The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach
Participants has been underwent:
- AP-RARP
- RS-RARP
- anterior-RARP Researchers compared the three groups to see if AP-RARP combines the advantages of anterior and posterior RARP and is a feasible surgical option for the treatment of prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AP-RARP | – | Procedure: the robot-assisted laparoscopic radical prostatectomythe robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach |
| RS-RARP | – | Procedure: the robot-assisted laparoscopic radical prostatectomythe robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach |
| anterior-RARP | – | Procedure: the robot-assisted laparoscopic radical prostatectomyhe robot-assisted laparoscopic radical prostatectomy with anterior approach |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The clinical data of 233 patients treated between September 2020 and May 2022 at Nanjing Drum Tower Hospital were retrospectively analyzed.
Key inclusion criteria (4 listed)
- pathologically diagnosed with prostate cancer by prostate biopsy
- underwent robot-assisted laparoscopic surgery
- the surgery performed by Weidong Gan
- the extended pelvic lymphadenectomy (PLA) is performed on patients with high-risk prostate cancer (PSA≥20 ng/ml or Grade Group 4-5 or clinical stage ≥T2c) and those considered to have a possibility of lymph node metastasis based on imaging evaluation.
Key exclusion criteria (4 listed)
- Patients with a clinical and pathological TNM stage ≥T3b and N1
- patients with distant metastasis
- urinary incontinence before surgery
- received neoadjuvant therapy before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the robot-assisted laparoscopic radical prostatectomyWe collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared. | Procedure or surgery | AP-RARP, RS-RARP, anterior-RARP |
Primary outcome
urinary continence
Time frame: 0-6 month after surgery
was defined as using 0-1 pad a day
positive surgical margin
Time frame: 2 weeks after surgery
observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist
2 secondary outcomes
operating time
Time frame: the day of the surgery
intraoperative blood loss
Time frame: the day of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatectomy and Prostate Neoplasm, run by Nanjing University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary continence (time frame: 0-6 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.