NCT06543420

Brief Summary

This study is a single center, single blind, prospective randomized controlled trial. Patients undergoing robot assisted laparoscopic radical prostatectomy for prostate cancer were randomly divided into 1:1:1 groups, using lateral reconstruction, posterior reconstruction, or no reconstruction. Patients were followed up regularly after surgery and clinical data were collected, including daily use of urine pads, ICIQ-SF score, 24-hour urine leakage, I-QoL score, etc., to evaluate the improvement effect of lateral reconstruction on urinary control and the difference in effect between lateral reconstruction and posterior reconstruction, thereby improving the quality of life of prostate cancer patients after surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
2mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jul 2024Jul 2026

Study Start

First participant enrolled

July 22, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2026

Expected
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

August 3, 2024

Last Update Submit

August 6, 2024

Conditions

Prostate Cancer

Keywords

Prostate cancerLevator ani muscle reconstructionUrinary incontinence recoveryRobot-assisted radical prostatectomyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Recovery rate of urinary incontinence

    Urinary incontinence recovery is defined as using 0 urinary pads per day

    1,3,6,9,12 months after operation

Secondary Outcomes (5)

  • The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score

    1,3,6,9,12 months after operation

  • Incontinence Quality of Life Questionnaire(I-QOL) Score

    1,3,6,9,12 months after operation

  • Perioperative and postoperative complications

    1,3,6,9,12 months after operation

  • Prostate-specific antigen

    1,3,6,9,12 months after operation

  • Duration of operation

    immediately after operation

Study Arms (3)

lateral reconstruction group

EXPERIMENTAL

After RARP surgery, lateral reconstruction is performed

Procedure: lateral reconstruction

posterior reconstruction group

EXPERIMENTAL

After RARP surgery, posterior reconstruction is performed

Procedure: posterior reconstruction

control group

NO INTERVENTION

No lateral or posterior reconstruction is performed after RARP surgery

Interventions

lateral reconstructionPROCEDURE

In lateral reconstruction group, lateral reconstruction is performed by suturing the levator ani muscle to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure.

lateral reconstruction group
posterior reconstructionPROCEDURE

In posterior group, prior to completion of the operation, the posterior fibrous tissues of the sphincter are joined to the residual Denonvilliers fascia on the posterior bladder wall 1-2 cm cephalad and dorsally to the new bladder neck.

posterior reconstruction group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with prostate cancer and preoperative clinical stage of cT2\~T3aN0M0
  • Complies with the indications for RARP surgery

You may not qualify if:

  • History of urinary incontinence or urethral stricture
  • Previous prostate related surgical treatment
  • Contraindications for RARP surgery
  • The patient or their family members refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Posterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsArthroplastySurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Kan Gong

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kan Gong, MD

CONTACT

(86)-010-83572075kan.gong@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 9, 2024

Study Start

July 22, 2024

Primary Completion

July 21, 2025

Study Completion (Estimated)

July 21, 2026

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

CN(1)