Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05462392 |
| Other study ID # |
NKJSSQXCKXT02-WG |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 28, 2022 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
August 2023 |
| Source |
The Affiliated Hospital of Qingdao University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A single-blinded, prospective randomized parallel controlled clinical trial is designed and
will be conducted from July 2022 to November 2023 (anticipated). One hundred and thirty-six
patients (anticipated) with renal cancer or bladder cancer or prostate cancer will be
enrolled in this study. Those patients will be enrolled by two hospital centers and the
patients will be randomly divided into the Micro Hand S surgical robot group and the da Vinci
surgical robot group. Robot-assisted partial nephrectomy, radical cystectomy, and radical
prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot. The
success rate of operation, assembly time, operation time, intraoperative hemorrhage,
continence rate (if applicable), postoperative pain, comprehensive complication index,
resident time and surgeon satisfaction were recorded. The aim of the study is to determine
whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority
outcomes in urological surgeries compared with the prevalent da Vinci robot.
Description:
Objective: To determine whether the newly developed Chinese Micro Hand S surgical robot
results in non-inferiority outcomes in partial nephrectomy, radical cystectomy, and radical
prostatectomy, compared with the prevalent da Vinci robot.
Design: A single-blinded, prospective randomized parallel controlled clinical trial will be
conducted from July 2022 to November 2023 (anticipated). One hundred and thirty-six patients
(anticipated) with renal cancer or bladder cancer or prostate cancer will be enrolled in this
study. Those patients will be enrolled by two hospital centers and the patients will be
randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot
group.
Interventions: Robot-assisted urological surgeries, such as partial nephrectomy, radical
cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the
da Vinci robot.
Main measures: The main outcome was the success rate of operation. Surgical success was
defined as that the surgical procedures were completed by the experimental or control product
without transferring to non-robotic surgery. Secondary outcomes included intra- and
post-operative complications, comprehensive complication index, assembly time, operation
time, intraoperative hemorrhage, postoperative pain, resident time, surgeon satisfaction,
incidence of adverse events, instrument malfunction, vital signs, routine blood test, hepatic
and liver function.
Background:
Prostate cancer is a common disease of elderly male. With the continuous growth of life
expectancy, the change of diet structure and the improvement of diagnostic technology, the
incidence rate of prostate cancer has increased in recent years. Radical prostatectomy can be
performed for cancer confined within the prostate capsule, which is also the best treatment
for prostate cancer. At present, the commonly used surgical methods include traditional open
prostatectomy, laparoscopic prostatectomy, and robot-assisted prostatectomy.
Minimally invasive surgery has always been the unremitting pursuit of surgeons. In the past
decade, da Vinci robot system has expanded rapidly in China, especially in some fields of
Urology, showing great advantages. In July 2000, da Vinci robotic surgery system was approved
by FDA for clinical surgery. In July 2001, binder and others completed the world's first da
Vinci robotic surgery system assisted laparoscopic radical prostatectomy. Since then, da
Vinci robotic surgery has been widely used in clinical surgery worldwide, such as Urology,
general surgery, cardiothoracic surgery, obstetrics and Gynecology, pediatric surgery, etc.
In recent ten years, da Vinci robotic surgery in China has developed rapidly, and the number
of urological surgery cases is increasing rapidly. It is widely used in radical
prostatectomy, partial nephrectomy, radical cystectomy, pyeloplasty, adrenalectomy and other
urological surgery. This is mainly due to the unique anatomical structure of Urology, which
enables da Vinci system to take its advantages such as 3D high-definition vision, precise
cutting and separation, intracavitary suture technology, and short learning curve.
The special anatomical position of the prostate and the surrounding anatomical structure
determine the difficulty of the operation. In terms of learning curve, it needs 50-100 cases
for laparoscopic surgery to pass the learning curve, and it needs 10-20 cases for da Vinci
robotic surgery system to pass the learning curve; In terms of visual field, the anatomy of
robot assisted surgery is clearer, which is conducive to the protection of urethral membrane
and neurovascular bundle, and sexual function, and the "double construction" of anatomy and
function. In addition, it also has the characteristics of less bleeding and complications,
rapid postoperative recovery, short hospital stay, and can achieve the same or better
oncological and functional results.
In nephrectomy or partial nephrectomy, compared with laparoscopic surgery, the learning curve
is greatly shortened; By providing high-resolution and three-dimensional images, magnifying
the images can make the surgical field clearer; Moreover, the da Vinci robotic surgery system
has seven degrees of freedom, which can simulate the movement of the hand, so that the
surgeon can better complete the incision, fine suture and reconstruction, zoom action, tremor
filtering, which can alleviate the hand fatigue of the surgeon, greatly increase the safety
of hand surgery, reduce the time of renal warm ischemia, and maximize the protection of renal
function.
In conclusion, when performing radical prostatectomy, radical cystectomy or partial
nephrectomy using robot surgery system, it has certain advantages compared with laparoscopic
surgery, and it also needs to record its related complications, especially electrical
machinery related complications.
Method:
The study was designed as a single-blind prospective randomized clinical trial since it is
inevitable for the surgeon to know what kind of robot to use during the operation. After
obtaining the approval of the Ethics Review Committee and other relevant institutions, a
total of 136 patients will be included in this study from from July 2022 to November 2023
(anticipated). Those patients will be enrolled by two hospital centers and the patients will
be randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical
robot group. All enrolled patients were fully informed and signed the informed consent.
Patients were randomly assigned to each group in a 1:1 ratio, and information of the grouping
and intervention measures were not available to patients. Patients of each group were matched
for age, sex, body mass index (BMI), and complications to reduce confounding intervention
factors. Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy
will be conducted using the Micro Hand S robot or the da Vinci robot. The success rate of
operation, assembly time, operation time, intraoperative hemorrhage, continence rate (if
applicable), postoperative pain, comprehensive complication index, resident time and surgeon
satisfaction were recorded.
Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy will be
conducted using the Micro Hand S robot or the da Vinci robot. During the operation, the
assembly time, intraoperative blood loss, operation time, operation success rate, and the
adjacent organ and vascular injury caused by the failure of the tested system were recorded.
Pain score was analyzed 24±2 hours after the surgery. The vital signs (temperature, pulse,
respiration, blood pressure) were measured on the 3rd day postoperatively. Meanwhile, the
routine blood test (red blood cells, white blood cells and neutrophils, platelet,
hemoglobin), liver and renal function (ALT, AST, TP, ALB, GLU, TBIL, BUN, and CREA), the
electrolyte (K, Na, Cl, Ca), blood sugar, and color ultrasound of liver, gallbladder,
pancreas and spleen were checked. Operating surgeons filled in the satisfaction questionnaire
postoperatively. Furthermore, the patients' postoperative condition changes, postoperative
medication, postoperative complications, and resident time were also recorded. All the
patients were followed up by telephone at 30±5 days postoperatively to evaluate the incidence
of adverse events.
