New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection

NCT06355076 | Recruiting

• 1 other identifier: CSZ03
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• complication

  at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation

• PSA

  at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation

• recurrence

  at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation

Study Arms (2)

New urethral reconstruction arm

EXPERIMENTAL

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

Traditional bladder urethral anastomosis arm

ACTIVE COMPARATOR

End to end anastomosis of bladder and urethra

Procedure: New urethral reconstruction

Interventions

New urethral reconstruction PROCEDURE

This kind of reconstruction suture has larger area, higher firmness, better fixation of the position of broken end and prolongation of functional length.

New urethral reconstruction arm; Traditional bladder urethral anastomosis arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital

Jinan, Shandong, 276600, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 33551295 BACKGROUND

• 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.

  PMID: 28578433 BACKGROUND

• 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.

  PMID: 17079070 BACKGROUND

• 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.

  PMID: 18354103 BACKGROUND

• 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.

  PMID: 33833445 BACKGROUND

• 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.

  PMID: 15382185 RESULT

• 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.

  PMID: 36434138 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shouzhen Chen, Dr.

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Shouzhen Chen, Dr.

CONTACT

18560089085; chensz@mail.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in the experimental or control group, as well as their family members, are unaware
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 9, 2024
• Study Start: February 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2024

Record last verified: 2023-09

Locations

CN (1)