Prostate Cancer Clinical Trial
Official title:
Hyaluronic Acid-Carboxymethylcellulose Reduced Postoperative Bowel Adhesions Following Laparoscopic Urologic Pelvic Surgery: a Prospective, Randomized, Controlled, Single-Blind Study
To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose following laparoscopic pelvic surgery (radical prostatectomy).
Methods This was a prospective, randomized, controlled, single-blind, parallel-group study
using HA/CMC (marketed as Guardix-sol®, Hanmi Medicare, Seoul, Korea) in patients who
underwent laparoscopic radical prostatectomy between November 2011 and June 2014. All the
patients were informed in detail about the aims and the procedures of the study and they
signed a written informed consent prior inclusion into the study. The protocol and the
written informed consent were approved by the local ethical committee (Catholic Medical
Center, Clinical Research Coordinator Center; approval number XC11DIMI10098H).
Subjects Men who were 50-75 years old and diagnosed with prostate cancer were eligible if
they were scheduled to undergo laparoscopic radical prostatectomy. Exclusion criteria
included any history of abdominal or pelvic surgery, hypersensitivity or an allergic
reaction to the study material, pelvic lymph node dissection at the same time as
prostatectomy, the presence of surgical site infection or contamination, a history of a
medical disease causing bowel adhesion, or a history of severe drug allergies.
Study design and protocol The laparoscopic radical prostatectomy was performed in same
surgical procedures and steps by two surgeons (USH and JSK) who have experienced over 150
cases of laparoscopic radical prostatectomy. The laparoscopic radical prostatectomy was
performed using the five-port fan-shaped transperitoneal approach. After the introducing the
peritoneal cavity, incising the parietal peritoneum between the medial umbilical ligaments
are incised and dissection is carried through the fatty alveolar tissue to develop the space
of Retzius. After that, the surgical steps are following order (1) incision of the
endopelvic fascia; (2) ligation of the dorsal vein complex; (3) division of the bladder
neck; (4) dissection of the seminal vesicles; (5) incision of the Denonvillier fascia and
control of the lateral pedicles with antegrade neurovascular bundle dissection; (8) apical
dissection and division of the dorsal vein and the urethra; (9) urethrovesical anastomosis.
Considering about 30% of dropout rate (under the assumption of 40% difference between HA/CMC
treatment group and the control group based on previous similar study10), by which the
target enrollment for this trial was 60 subjects (30 subjects per group). The sample size
was determined assuming a level of significance of α=0.05 (two-side) and a 80% statistical
power of test. All patients were randomly assigned to either the HA/CMC treatment group
(n=30) or the control group (n=30) using a computer-generated randomization table. The
surgeon was blinded to treatment assignments before randomization. Patients were also
blinded to their treatment group throughout the study. HA/CMC was applied in all port sites
and the peritoneal incision line of the medial umbilical ligament with a single-use
applicator attached to a sprayer that allowed for the precise application to the required
sites (Fig. 1). The amount of HA/CMC applied was 5 ml. Information regarding the duration of
illness and medical history were collected at the time of enrollment (V0). Viscera slide
ultrasound and plain X-ray were recorded at the time of the operation (V0) and 12 (V1) and
24 week (V2) after the operation.
The primary end point was the difference in excursion distance on viscera slide ultrasound
between V0 and V2. The secondary end point was excursion distance on viscera slide
ultrasound at V2 and the presence of restriction of viscera slide on ultrasound at V2.
Assessment of efficacy and safety Twelve and 24 weeks after the operation, bowel adhesion to
the abdominal wall was evaluated by ultrasound and plain X-rays. We performed viscera slide
ultrasound according to a technique that has been previously described [11].By dividing the
abdomen into 5 segments and examining the viscera slide in each segment, a prediction of the
extent of the adhesions was made for each patient. Figure 2 shows the division of the
abdomen into 5 segments and their numbering. At the time of the viscera slide ultrasound,
data were also collected on the location of the scars on the abdomen. The main point of
interest was the distance of the longitudinal excursion of the selected area in relation to
the fixed abdominal wall. Normal viscera sliding movement was defined as equal to or greater
than 1 cm of longitudinal movement. Restricted viscera slide was defined as less than 1 cm
of longitudinal movement during both normal and exaggerated respiration. The ultrasound was
performed by two sonographers who had been well instructed for study assessment. The
assessment by ultrasound was double-checked. The sonographer, radiologist and all accessor
was blind to the randomization during the all study period.
Statistical Analysis The data for this study are expressed as mean ± standard deviation of
the mean. The comparisons of the 2 groups were made using a chi-test, an independent
Student's t test, or repeated measure ANOVA. P-values <0.05 were considered significant.
Statistical calculations were carried out with IBM SPSS statistics, Version 21 (IBM Corp,
Armonk, NY).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |