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Clinical Trials/NCT07251621
NCT07251621CompletedNot Applicable

Evaluation of the Application Effect of a Surgical Navigation System in HoLEP Surgery

Chinese PLA General Hospital1 site in 1 country150 target enrollmentStarted: April 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
postoperative complications

Study Overview

Brief Summary

3D imaging-assisted surgical navigation system was established using the following specific procedures: 1) Prostate MRI Acquisition and 3D Reconstruction: patient prostate MRI images are acquired, and professional engineers complete 3D reconstruction; 2) Data Import to Diagnostic Ultrasound System: Reconstructed prostate MRI images and P-3DRI (Prostate 3D Reconstruction Image) data are imported into the Diagnostic Ultrasound system; 3) Transrectal Ultrasound Probe Placement: The transrectal ultrasound probe is secured to a dedicated holder. The probe is inserted into the patient's rectum to locate the prostate. After manual adjustment to optimize imaging, the holder is fixed in position; 4) Initial Position Registration: The Diagnostic Ultrasound system integrates prostate MRI, P-3DRI, and real-time ultrasound images. Spatial correspondence between P-3DRI and the actual prostate position is established using real-time ultrasound; 5) Cystoscope-Electromagnetic Navigation Assembly: A self-designed electromagnetic navigation connector links the electromagnetic sensor to the cystoscope. The ultrasound probe is simultaneously equipped with an electromagnetic sensor; 6) Real-time Spatial Tracking and Fusion: The electromagnetic navigation module tracks spatial positions of surgical instruments and the ultrasound probe. These positions are fused with real-time ultrasound coordinates.

Through the above steps, the relative position between surgical instruments and the prostate is displayed in real time, achieving intraoperative navigation. All procedures were performed by the same Associate Chief Physician at our medical center. Based on the use of the 3D imaging-assisted surgical navigation system during surgery, patients were divided into an Observation group and a Control group.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1) Clinically diagnosed BPH patients with LUTS; 2) Voluntarily participated in the clinical trial and provided written informed consent; 3) Met the surgical intervention indications outlined in the 2019 'Chinese Guidelines for Diagnosis and Treatment of Urological Diseases'; 4) Completed preoperative BPH evaluations, including International Prostate Symptom Score (IPSS) and Quality of Life (QoL) assessment.

Exclusion Criteria

  • 1) Refusal to participate in the clinical trial; 2) Presence of severe uncontrolled medical conditions or psychiatric disorders; 3) Cognitive impairment impeding normal communication.

Outcomes

Primary Outcomes

postoperative complications

Time Frame: month 1;month 3;

Urinary Incontinence (Defined as an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score ≥ 1), Urethral Stricture (Defined as recurrence of dysuria or narrowed urine stream postoperatively, confirmed by cystoscopy)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chinese PLA General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Qing Yuan

Professor

Chinese PLA General Hospital

Study Sites (1)

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