Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001219875
Ethics application status
Not yet submitted
Date submitted
4/11/2012
Date registered
19/11/2012
Date last updated
2/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Robot-assisted laparoscopic radical prostatectomy versus laparoscopic radical prostatectomy: A comparison of one surgeon's outcomes
Scientific title
Effectiveness and Safety of robot-assisted laparosopic radical prostatectomy versus laparoscopic radical prostatectomy in patients with prostate cancer by one experienced laparoscopic surgeon :A prospective controlled Trial from China
Secondary ID [1] 280639 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 286654 0
Surgical techniques for prostatectomy 287777 0
Condition category
Condition code
Cancer 286945 286945 0 0
Prostate
Surgery 288126 288126 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
25 male patients with clinically localized prostatic carcinoma underwent prostatectomy by robot-assisted approach by a single surgeon(using the da Vinci Surgical System). The estimated operative time is around 3-4hours.The surgical technique are transperitoneally,antegrade, energy-free (use of surgical suture needle to control the prostatic
vascular structure with no use of thermocoagulation,
either mono or bipolar at the lateral
aspect of the prostate)
Participants will be monitored for 1 year post surgery
Intervention code [1] 285035 0
Treatment: Surgery
Comparator / control treatment
25 male patients with clinically localized prostatic carcinoma underwent prostatectomy by laparoscopic approach by a single surgeon. The estimated operative time is around 4-5 hours. The surgical technique are the same with Robot-assisted.
Participants will be monitored for 1 year post surgery
Control group
Active

Outcomes
Primary outcome [1] 287287 0
Continence
Timepoint [1] 287287 0
Continence was defined as no leakage or as no
need of use of any protective pad.Continence were
assessed by telephone interview at 1, 3, 6, and 12
months after surgery.
Primary outcome [2] 287288 0
Potency
Timepoint [2] 287288 0
Potency was defined both as capability of intercourse
(with or without phosphodiesterase type 5 [PDE5] inhibitors).Capability of intercourse were
assessed by telephone interview at 1, 3, 6, and 12
months after surgery. Capability of intercourse
was assessed through the questions (Were you able to insert
your penis into your partner's vagina? Did your
erection last long enough to have successful intercourse?).
If the patient affirmed that he was able to
get an erection firm enough for sexual intercourse,
he was further asked about the use or not of PDE5
inhibitors and the frequency of this use.
Primary outcome [3] 287289 0
postoperative positive margin
Timepoint [3] 287289 0
Positive surgical margin (PSM) was considered
when cancer cells were found in contact with
the ink-marked resection margin.A PSM < 1 mm
was defined focal. The TNM 2002 classification
was used for the staging.The PSM will be assessed by postoperative pathological report. The report were reviewed 1 week after surgery.
Secondary outcome [1] 297837 0
blood loss(ml)
Timepoint [1] 297837 0
blood loss will be assessed by vacuum extractor .And the amount of bleeding were recorded in the operative records. The records were reviewed 1 day after surgery.
Secondary outcome [2] 297838 0
Total operative time
Timepoint [2] 297838 0
Total operative time was regarded as the time between initiation of the skin incision and end of wound closure according to operative records. The operative records were reviewed 1 week after surgery

Eligibility
Key inclusion criteria
(1) Prostate cancer patients diagnosed by pathologic examination , The life expectancy of more than 10 years, localized prostate cancer(T1a-T2c) (2) written informed consent was obtained.
Minimum age
40 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(1)Lymphatic metastasis and bone metastasis assessed by computed tomography, magnetic resonance imaging,Positron Emission Computed Tomography ; (2) patients had received neoadjuvant chemotherapy;(3) complicated by cardiopulmonary dysfunction,celiac inflammation,coagulation abnormalities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
serially numbered, opaque, sealed envelopes.When researchers identified the conformity of subjects, the envelopes are opened and the subjects are assigned to the corresponding test group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
enter the website which is 'http://www.random.org/integers' to get the computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4351 0
China
State/province [1] 4351 0
Shanghai

Funding & Sponsors
Funding source category [1] 285406 0
Self funded/Unfunded
Name [1] 285406 0
Country [1] 285406 0
China
Primary sponsor type
Hospital
Name
Changhai Hospital
Address
Department of Urology, Changhai Hospital, Second Military Medical University,168 Changhai road yangpu district Shanghai
200433
Country
China
Secondary sponsor category [1] 284258 0
None
Name [1] 284258 0
Address [1] 284258 0
Country [1] 284258 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288345 0
Changhai Hospital Ethics Committee
Ethics committee address [1] 288345 0
Department of Urology, Changhai Hospital, Second Military Medical University,168 Changhai road yangpu district Shanghai
200433
Ethics committee country [1] 288345 0
China
Date submitted for ethics approval [1] 288345 0
10/02/2012
Approval date [1] 288345 0
Ethics approval number [1] 288345 0

Summary
Brief summary
We assessed the learning curve for an experienced laparoscopic surgeon during the transition for laparoscopic surgery to the robot-assisted operations.So we conducted the RCT and compared the perioperative outcomes of the 2 groups.One group were 25 cases of laparoscopicradical prostatectomy and another were 25 cases of robot-assisted laparoscopic prostate cancer
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34284 0
A/Prof Gaoxu
Address 34284 0
Department of Urology, Changhai Hospital, Second Military Medical University
168 Changhai road yangpu district Shanghai(200433)
Country 34284 0
China
Phone 34284 0
+8602131161718
Fax 34284 0
Email 34284 0
[email protected]
Contact person for public queries
Name 17531 0
A/Prof Gaoxu
Address 17531 0
Department of Urology, Changhai Hospital, Second Military Medical University
168 Changhai road yangpu district Shanghai(200433)
Country 17531 0
China
Phone 17531 0
+8602131161718
Fax 17531 0
Email 17531 0
[email protected]
Contact person for scientific queries
Name 8459 0
Dr Wang Hai-feng
Address 8459 0
Department of Urology, Changhai Hospital, Second Military Medical University
168 Changhai road yangpu district Shanghai(200433)
Country 8459 0
China
Phone 8459 0
+8602131161718
Fax 8459 0
Email 8459 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.