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.
This study is a single center, single blind, prospective randomized controlled trial. Collect baseline data from enrolled patients Materials were randomly divided into experimental group A (lateral reconstruction group), experimental group B (posterior reconstruction group), and control group (non reconstruction group) in a 1:1:1 ratio using a computer-generated random number sequence. In the control group (non reconstruction group), no lateral or posterior reconstruction was performed after RARP surgery. In experimental group A (lateral reconstruction group), lateral reconstruction was performed after RARP surgery, in which the levator ani muscle was sutured to the prostatic collateral ligament and fascia to strengthen the lateral posterior support structure. In experimental group B (post reconstruction group), post reconstruction was performed after RARP surgery. This study used blinding on patients to avoid subjective factors affecting the results of whether reconstruction was performed or not. Preoperative collection of baseline data from patients includes age, BMI, history of abdominal surgery, most recent PSA, PI-RADS score, prostate volume, prostate puncture related data (histological type, number of positive needles/puncture needles, Gleason score, maximum tumor proportion), PSMA PET-CT results, neoadjuvant therapy regimen, International Advisory Committee on Urinary Incontinence Questionnaire Brief (ICIQ-SF) score, International Index of Erectile Function (IIEF-5) score, International Prostate Symptom Score (IPSS) score, etc. Collect postoperative patient surgical data (including ASA score, surgical duration, intraoperative blood loss, etc.), hospitalization data (including hospitalization duration, hospitalization costs, etc.), and pathological data (including lesion diameter, histological type, Gleason score, pathological staging, positive surgical margin, invasion of capsule, invasion of seminal vesicle and adjacent tissues, etc.). Follow up visits were conducted on patients at 1, 3, 6, 9, and 12 months postoperatively, and relevant clinical data were collected, including the number of urine pads used per day during follow-up, ICIQ-SF score, 24-hour urine leakage (accurately measured by purchasing an electronic scale for patients), perioperative and postoperative complications, IIEF-5 score, PSA, and urinary incontinence quality of life questionnaire (I-QOL) score, in order to evaluate the improvement effect of lateral reconstruction on urinary control and quality of life, as well as the impact on complication incidence, erectile function, and tumor control. The differences in the effects of lateral reconstruction and posterior reconstruction on urinary control recovery and quality of life improvement were compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
192
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.
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.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGRecovery rate of urinary incontinence
Urinary incontinence recovery is defined as using 0 urinary pads per day
Time frame: 1,3,6,9,12 months after operation
The International Consultation on Incontinence Questionnaire Short-form(ICIQ-SF) Score
ICIQ-SF is a questionnaire used to evaluate urinary incontinence and assess the recovery of postoperative urinary incontinence in patients. The range of scores is from 0 to 21, with higher scores indicating more severe urinary incontinence.
Time frame: 1,3,6,9,12 months after operation
Incontinence Quality of Life Questionnaire(I-QOL) Score
I-QoL is a questionnaire used to evaluate the quality of life of patients with urinary incontinence after surgery. The range of scores is from 0 to 100, with higher scores indicating higher quality of life.
Time frame: 1,3,6,9,12 months after operation
Perioperative and postoperative complications
Collect perioperative and postoperative complications such as bleeding and pain to compare the differences between two reconstruction methods and non reconstruction methods.
Time frame: 1,3,6,9,12 months after operation
Prostate-specific antigen
Biochemical recurrence is defined as two consecutive postoperative PSA levels above 0.2 ng/ml with an upward trend
Time frame: 1,3,6,9,12 months after operation
Duration of operation
The purpose of collecting surgical duration is to compare whether there are differences between two reconstruction techniques and no reconstruction.
Time frame: immediately after operation
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