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Trial Title:
New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection
NCT ID:
NCT06355076
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The experimental group received a new urethral reconstruction technique, which involves
suturing the levator ani muscle with the lateral striated muscle of the urethra, the
dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before
performing bladder urethral anastomosis. After the reconstruction is completed, the end
to end anastomosis of the bladder urethra is performed
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Patients in the experimental or control group, as well as their family members, are
unaware
Intervention:
Intervention type:
Procedure
Intervention name:
New urethral reconstruction
Description:
This kind of reconstruction suture has larger area, higher firmness, better fixation of
the position of broken end and prolongation of functional length.
Arm group label:
New urethral reconstruction arm
Arm group label:
Traditional bladder urethral anastomosis arm
Summary:
The purpose of this clinical trial is to compare new reconstruction and anastomosis in
robot-assisted radical laparoscopic resection It will also understand the possibility of
exploring new reconstruction in completely solving patients' postoperative urinary
incontinence The main questions it aims to answer are:
Is there a significant improvement in urinary control in patients with new reconstruction
compared with patients with anastomosis? The researchers compared the new reconstruction
with anastomosis in robot-assisted laparoscopic radical resection to see if the new
reconstruction improved urinary incontinence after operation.
Participants will:
The intervention group adopted the new reconstruction proposed by our team; End-to-end
anastomosis was performed in non-intervention group.
Detailed description:
It is one of the most common malignant tumors in urology, and its incidence rate is the
second among male malignant tumors in the world. In recent years, with the economic and
social development in China, the incidence rate has increased year by year, which
seriously threatens the Radical resection is the current treatment plan. Although radical
surgery can prolong the survival time of patients, because of the surgical injury, the
incidence of urinary incontinence and sexual function after operation is high, which
greatly affects the physiological health, mental health and social function of patients.
In order to solve the above problems, Professor Shi Benkang's team of Urology Department
of Qilu Hospital of Shandong University improved the existing urinary tract
reconstruction after consulting a large number of related literatures and combining with
the new findings of our team's previous anatomical work, which needed to be carried out
under Da Vinci Xi surgical system. By continuously suturing the fascia on the surface of
levator anal muscle and the posterior dorsal median ridge (MDR) and Dirichlet fascia of
the lateral tissue, it achieved the purpose of protecting the apical saccular tube bundle
(NVB) and maintaining the stability of the length of vascular and nerve lengthening
function in the posterior MDR We found that the postoperative urinary incontinence of
patients with new reconstruction technique is obviously better than that of anastomosis,
which provides a new idea for improving the postoperative urinary incontinence of RARP
patients.
Criteria for eligibility:
Criteria:
Inclusion criteria:
- Age ≥ 18 years old, confirmed by puncture pathology as prostate cancer
- The tumor has no extensive distant metastasis, or has reached a resectable state
through neoadjuvant chemotherapy and endocrine therapy
- Willing to accept robot assisted laparoscopic radical prostatectomy
Exclusion criteria:
- Tumor metastasis cannot achieve curative effect through surgery
- Concomitant severe cardiovascular and cerebrovascular complications
- Merge severe mental and neurological disorders
- Poor liver and kidney function
- Refusal to accept robot assisted laparoscopic radical prostatectomy
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu hospital
Address:
City:
Jinan
Zip:
276600
Country:
China
Status:
Recruiting
Contact:
Last name:
shouzhen chen
Phone:
18560089085
Email:
201900412102@mail.sdu.edu.cn
Start date:
February 5, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355076
