New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection

NCT ID: NCT06355076

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-05
• Study Completion Date: 2026-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

New urethral reconstruction

Intervention Type: PROCEDURE

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

Traditional bladder urethral anastomosis arm

End to end anastomosis of bladder and urethra

Group Type: ACTIVE_COMPARATOR

New urethral reconstruction

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shouzhen Chen, Dr.

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Locations

Qilu hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shouzhen Chen, Dr.

Role: CONTACT

chensz@mail.sdu.edu.cn

18560089085

Facility Contacts

shouzhen chen

Role: primary

201900412102@mail.sdu.edu.cn

18560089085

References

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Reference Type: BACKGROUND

PMID: 33551295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28578433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17079070 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 18354103 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: RESULT

PMID: 15382185 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36434138 (View on PubMed)

Other Identifiers

CSZ03

Identifier Type: -

Identifier Source: org_study_id