Clinical trial NCT06355076: New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection
Official title: Comparison of New Reconstruction and Anastomosis in Robot-assisted Laparoscopic Radical Resection: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: Recovery of urinary incontinence
timeFrame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Secondary outcomes:
measure: complication
timeFrame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
measure: PSA
timeFrame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
measure: recurrence
timeFrame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Shouzhen Chen, Dr.
role: STUDY_CHAIR
References:
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citation: Mungovan SF, Carlsson SV, Gass GC, Graham PL, Sandhu JS, Akin O, Scardino PT, Eastham JA, Patel MI. Preoperative exercise interventions to optimize continence outcomes following radical prostatectomy. Nat Rev Urol. 2021 May;18(5):259-281. doi: 10.1038/s41585-021-00445-5. Epub 2021 Apr 8.
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citation: Qi W, Dou M, Xu L, Qu S, Zhu Y, Chen S, Shi B. Robot-assisted radical prostatectomy using a novel urethral reconstruction technique vs standard vesicourethral anastomosis. A retrospective cohort study. World J Urol. 2023 Jan;41(1):51-58. doi: 10.1007/s00345-022-04208-8. Epub 2022 Nov 24.