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

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Benign Prostate Hypertrophy(BPH)

Treatments: Procedure: use the 3D imaging-assisted surgical navigation system during surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07251621

S202403101

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

use of the 3D imaging-assisted surgical navigation system during surgery

Experimental group

Description:

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

Treatment:

Procedure: use the 3D imaging-assisted surgical navigation system during surgery