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Transient or persistent urinary incontinence after radical prostatectomy (RP) deeply affects the quality of life of patients
.
At present, robot-assisted radical prostatectomy (RARP) is considered to provide the best tumor and functional results due to its enlarged field of view and high precision.
Transient or persistent urinary incontinence after radical prostatectomy (RP) deeply affects the quality of life of patients
Recently, the European Journal of Urology (EU) published a study showing that LRP and RAPR have no difference in tumor treatment effects, but the latter is better in terms of urinary control three months after surgery
Clinical design
Clinical designClinical designClinical designSurgical staff requirements
Surgical staff requirements Surgical staff requirements(1) All surgeons have experience in RARP and LRP, and each type of operation exceeds 150 cases
.
.
(2) Because most German patients prefer to perform surgery with the help of robots, participants were randomly assigned to perform RARP or LRP at a ratio of 3:1
.
.
(3) Before the end of the 3-month evaluation and the extraction of the preliminary research results, the patient will blind the surgical method
.
Once the patient is informed of the type of surgery performed, the 6-month and 12-month results reported by the patient are obtained in the context of an open trial
(3) Before the end of the 3-month evaluation and the extraction of the preliminary research results, the patient will blind the surgical method
Inclusion criteriaInclusion criteria
Exclusion criteria
Exclusion criteria Exclusion criteria
Surgical approach
Surgical surgical approach(1) According to the doctor's choice, adopt transperitoneal or extraperitoneal approach, and perform pelvic lymph node dissection (PLND) in all intermediate and high-risk patients according to D'Amico standards
.
.
(2) All lymph node dissections use a standardized extended PLND template, and the upper edge is the common iliac artery
.
.
Note: The preoperative nerve preservation is designed according to clinical standards, and is modified according to the frozen section plan during the operation (there is evidence that the bundle is invaded, and the bundle is further removed on the affected side)
.
According to the surgeon's decision and local postoperative agreement, the patient was discharged from the hospital after the drainage tube was removed
Note: Note: The preoperative nerve preservation is designed according to clinical standards and is modified according to the frozen section plan during the operation (there is evidence that the bundle is invaded, and the bundle is further removed on the affected side)
Follow-up arrangements
Follow -up arrangementsPatients were evaluated for function and tumor prognosis at admission, 1, 3, 6 and 12 months after surgery, and long-term tumor prognosis (prostate-specific antigen) was collected at 24 and 36 months.
The main indicators of the study
The main indicators of the research The main indicators of the research(1) The recovery of urinary incontinence three months after the catheter was removed
.
(If the urine pad is not used within 24 hours, it is considered to be back to normal)
(1) The recovery of urinary incontinence three months after the catheter was removed
.
(If the urine pad is not used within 24 hours, it is considered to be back to normal)
.
Secondary indicators
Secondary outcomes Secondary outcomes(1) The following questionnaire assessments will be performed at 1, 3, 6, and 12 months after surgery
(1) The following questionnaire assessments will be performed at 1, 3, 6, and 12 months after surgery(2) Consultation on Incontinence Questionnaire Brief Form (ICIQ-SF)
(2) Consultation on Incontinence Questionnaire Brief Form (ICIQ-SF)(3) International Index of Erectile Function (IIEF-5)
(3) International Index of Erectile Function (IIEF-5)(3) European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC-QLQ)
(3) European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC-QLQ)(4) Hospital Anxiety and Depression Scale (HADS-D)
(4) Hospital Anxiety and Depression Scale (HADS-D)(5) Tumor results were defined as positive surgical margins and biochemical recurrence at 3, 6, 12, 24, and 36 months after surgery
.
.
result
Result result resultA total of 782 patients were enrolled
A total of 782 patients were enrolledmain indicators
Main indicatorsMain indicators(1) At the 3-month follow-up, 54% of RARP patients did not use pads or safety pads, and the proportion of LRP patients was 46%
(1) At the 3-month follow-up, 54% of RARP patients did not use pads or safety pads, and the proportion of LRP patients was 46%Secondary indicators
Secondary outcomes Secondary outcomes(2) In patients with bilateral nerve preservation, the advantage of robot assistance is more obvious.
66% of RARP patients are in a stable urinary control state, and 50% of LRP patients are in a stable urinary control state
.
66% of RARP patients are in a stable urinary control state, and 50% of LRP patients are in a stable urinary control state
.
(3) The vast majority of patients with incontinence report a small amount of urine leakage every day, and only 9.
3% of RARP patients and 15% of LRP patients report moderate to large urine leakage
.
3% of RARP patients and 15% of LRP patients report moderate to large urine leakage
.
(4) According to ICIQ-SF, RARP and LRP, there are also statistical differences in the subjective evaluation of urinary incontinence at 1 month and 3 months after surgery
.
.
(5) The quality of life assessed by EORTCPR - 25 is better preserved with the assistance of robots
.
.
Results of further analysis
The result of further analysis The result of further analysis(1) There is a greater difference in the proportion of urinary control in patients with bilateral nerve preservation (RARP: 66%, LRP: 49%; p = 0.
005)
.
005)
.
(2) Age > 65 years old and surgery without nerve preservation are not conducive to urinary control :
(2) Age > 65 years old and surgery without nerve preservation are not conducive to urinary control :(3) Age > 65 years of urinary HR = 0.
69 (0.
54 - 0.
86, the p-= 0.
001 );
69 (0.
54 - 0.
86, the p-= 0.
001 );
(4) does not retain urine neural control the HR = 0.
56 (0.
43 - 0.
72, P < from 0.
0001 );
56 (0.
43 - 0.
72, P < from 0.
0001 );
(5) Unilateral neuroprotection ( vs bilateral neuroprotection) HR = 0.
66 (0.
44 0.
98), p = 0.
038
.
66 (0.
44 0.
98), p = 0.
038
.
The ICIQ-SF score also reflects that compared with patients in the LRP group, patients in the RARP group have improved continence at 3 months
.
.
Tumor treatment effect
Tumor treatment effect Tumor treatment effectThere is no significant difference between RARP and LRP in the prognosis of early tumors
.
.
Both techniques have shown to compare the surgical effect of positive margins (19% for RARP and 14% for LRP; p = 0.
19) Lymph node infiltration rate (RARP is 7.
8%, LRP is 4.
8%; p = 0.
38
19) Lymph node infiltration rate (RARP is 7.
8%, LRP is 4.
8%; p = 0.
38
Sexual function
Sexual function aspect Sexual function aspect(1) At 3 months postoperatively, 18% and 6.
7% of patients receiving nerve-sparing (bilateral or unilateral) RARP and LRP, respectively, reported having an erection sufficient for sexual intercourse (p = 0.
007)
.
7% of patients receiving nerve-sparing (bilateral or unilateral) RARP and LRP, respectively, reported having an erection sufficient for sexual intercourse (p = 0.
007)
.
(2) The sum of IIEF in the LRP group was 1.
54 points lower than the sum of IIEF in the RARP group on average (p = 0.
026)
.
54 points lower than the sum of IIEF in the RARP group on average (p = 0.
026)
.
(3) However, the EORC-PR25 questionnaire showed that at 3 months, the two techniques had no significant differences in sexual function and activity
.
.
(4) Preserving bilateral and unilateral nerves enhances the recovery of erectile function, and age is negatively correlated with recovery of sexual function (2.
53)
.
However, the various tools used have inconsistent assessments of effectiveness recovery
.
53)
.
However, the various tools used have inconsistent assessments of effectiveness recovery
.
complication
Complications ComplicationsThe incidence of complications was higher in the LRP group, but there was no difference (Clavien-Dindo classification): 87 cases (15%) in the RARP group and 41 cases (21%) in the LRP group had complications of any grade (p = 0.
097)
.
097)
.
in conclusion
Conclusion Conclusion ConclusionCompared with the laparoscopic approach, the early recovery of incontinence was better at 3 months after RARP
.
Age and intraoperative nerve preservation techniques further affect the recovery of incontinence
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The recovery of erectile function was also improved with the assistance of robots, but there was no significant difference in perioperative morbidity and early tumor prognosis
.
.
Age and intraoperative nerve preservation techniques further affect the recovery of incontinence
.
The recovery of erectile function was also improved with the assistance of robots, but there was no significant difference in perioperative morbidity and early tumor prognosis
.
references
References ReferencesStolzenburg JU, et al.
Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01).
Eur Urol (2021), https://doi.
org/ 10.
1016 /j.
eururo.
2021.
01.
030
Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First https://doi.
org/ 10.
1016/j.
eururo.
2021.
01.
030 Leave a message here