New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection

Comparison of New Reconstruction and Anastomosis in Robot-assisted Laparoscopic Radical Resection: a Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: New urethral reconstruction

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shouzhen Chen, Dr.; Phone Number: 18560089085; Email: chensz@mail.sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 276600
      • Recruiting
      • Qilu hospital
      • Contact: shouzhen chen; Phone Number: 18560089085; Email: 201900412102@mail.sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New urethral reconstruction arm; The experimental group received a new reconstruction technique, in which the levator anus and the dorsal median ridge (MDR) of the lateral striated muscle were sutured to the Dirichlet fascia for continuous suture before anastomosis	Procedure: New urethral reconstruction; This kind of reconstruction suture has larger area, higher firmness, better fixation of the position of broken end and prolongation of functional length.
Active Comparator: Traditional bladder urethral anastomosis arm; End to end anastomosis of bladder and urethra	Procedure: New urethral reconstruction; This kind of reconstruction suture has larger area, higher firmness, better fixation of the position of broken end and prolongation of functional length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of urinary incontinence	Recovery of urinary incontinence in intervention group and non-intervention group at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation	at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	complications include infection, bleeding, etc.	at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
PSA	Prostate Specific Antigen	at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
recurrence	Tumor recurrence	at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Chair: Shouzhen Chen, Dr., Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
• Ficarra V, Rossanese M, Crestani A, Alario G, Mucciardi G, Isgro A, Giannarini G. Robot-assisted Radical Prostatectomy Using the Novel Urethral Fixation Technique Versus Standard Vesicourethral Anastomosis. Eur Urol. 2021 Apr;79(4):530-536. doi: 10.1016/j.eururo.2021.01.028. Epub 2021 Feb 4.
• Cui J, Guo H, Li Y, Chen S, Zhu Y, Wang S, Wang Y, Liu X, Wang W, Han J, Chen P, Nie S, Yin G, Shi B. Pelvic Floor Reconstruction After Radical Prostatectomy: A Systematic Review and Meta-analysis of Different Surgical Techniques. Sci Rep. 2017 Jun 2;7(1):2737. doi: 10.1038/s41598-017-02991-8.
• Rocco B, Gregori A, Stener S, Santoro L, Bozzola A, Galli S, Knez R, Scieri F, Scaburri A, Gaboardi F. Posterior reconstruction of the rhabdosphincter allows a rapid recovery of continence after transperitoneal videolaparoscopic radical prostatectomy. Eur Urol. 2007 Apr;51(4):996-1003. doi: 10.1016/j.eururo.2006.10.014. Epub 2006 Oct 23.
• 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.
• Moore K, Allen M, Voaklander DC. Pad tests and self-reports of continence in men awaiting radical prostatectomy: establishing baseline norms for males. Neurourol Urodyn. 2004;23(7):623-6. doi: 10.1002/nau.20067.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: April 6, 2024
• First Posted (Estimated): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CSZ03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No