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ORIGINAL ARTICLE
Year : 2022 | Volume
: 33
| Issue : 2 | Page : 63-69
Does the timing of performing robot-assisted radical prostatectomy after prostate biopsy affect the outcome?
Chien-Ming Lai1, Richard C Wu2, Chun-Hsien Wu3, Chiang-Ting Wang4, Victor C Lin2
1 Division of Urology, Department of Surgery, Kaohsiung Armed Force General Hospital; Department of Urology, E-DA Hospital, Kaohsiung, Taiwan
2 Department of Urology, E-DA Hospital; School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan
3 Department of Urology, E-DA Hospital; Department of Nursing, I-Shou University; Department of Chemical Engineering and Institute of Biotechnology and Chemical Engineering, I-Shou University; School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan
4 Division of Urology, Department of Surgery, Kaohsiung Armed Force General Hospital, Kaohsiung, Taiwan
Correspondence Address:
Victor C Lin
No. 1, Yida Road, Jiaosu Village, Yanchao District, Kaohsiung 82445
Taiwan
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/UROS.UROS_39_21
Purpose: Prostate biopsy induced prostate hemorrhage and periprostate tissue inflammation which raised the concerns of increasing difficulty even in the era of robot-assisted radical prostatectomy (RARP). To evaluate the correlation between postoperative outcomes and the interval after biopsy, we compared surgical outcomes in different time interval (≤4 weeks, 4–8 weeks, and ≥8 weeks). Materials and Methods: We collected patients with localized prostate cancer who underwent RARP by a single experienced surgeon at our institute between April 2016 and February 2019. The complicated statuses such as previously transurethral resection of prostate, grossly nodal positive disease, or locally advanced disease were excluded. A total of 83 patients were enrolled retrospectively according to the regulation of the institutional review board in the institute. The patients were divided into three groups according to the time interval between prostate biopsy and RARP (≤4 weeks, 4-8 weeks and ≥ 8 weeks). The demographic information and perioperative and postoperative outcomes were collected and analyzed. Results: Regarding preoperative characteristics, there were similarities in the three groups. Concerning intraoperative outcomes, statistical difference was observed in mean estimated blood loss (253.1 vs. 158.9 vs. 170.9 ml, P = 0.047). In addition, operative time was similar among three groups (221.9 vs. 248.5 vs. 226.7, P = 0.199). There was no difference in positive surgical margin rate among three groups. The time interval groups did not correlate to prolonged days either urinary catheter indwelling or hospitalization (P > 0.05). There was no difference in decreased erection hardness scores at 12 months between 3 groups (−0.75 vs. −0.77 vs. −0.57, P = 0.556). Conclusion: In our experience, RARP can be effectively and safely performed in different time intervals after prostate biopsy without increasing total operative time or adversely compromising postoperative functionally and oncologic outcomes. However, performing RARP < 4 weeks after prostate biopsy did probably have the risk of increase estimated blood loss.
Keywords: Outcome, prostate biopsy, prostate cancer, robotic-assisted radical prostatectomy
Prostate cancer is a disease in aging males worldwide, with a higher prevalence in the USA and in Europe than in Asia.[1] It is the second most common malignancy in men.
In 2018, the age-standardized rate of this disease was 73.7 (per 100,000 people) in North America and 62.1 in Europe, and the rates of incidence in Africa and Asia were 26.6 and 11.5, respectively.[1] In Taiwan, prostate cancer is the seventh leading cause of cancer death and the fifth leading cancer in men.[2],[3] Moreover, a persistent and rapidly increasing trend has been observed in both incidence and mortality rates in the country.[4]
For localized prostate cancer, the respective cumulative incidence of distant metastases and deaths from prostate cancer at 18 years of age was 26.1% and 17.7% for a radical prostatectomy group versus 38.3% and 28.7% for a watchful-waiting group, respectively.[5] Radical prostatectomy provided better cancer-specific survival and life expectancy than did watchful waiting. There is no medical standard[6] for the optimal time between biopsy and surgery. In general, surgery might be deferred for 6–8 weeks after prostatic needle biopsy to reduce inflammatory adhesion and hematoma between the prostate and surrounding tissue.[6],[7] Surgery might be deferred for 12 weeks if the patient received transurethral resection of the prostate (TURP).[7]
The first da Vinci robot in Taiwan was introduced in 2004.[8] Since then, these robots have been used in many urological surgeries and have changed the urologic field, and the procedure is thought to be both safer and more efficient than the classic standard laparoscopic and open surgery.[8] Robot-assisted radical prostatectomy (RARP) is associated with less blood loss and lower transfusion rates than open surgery. Moreover, RARP preserves the neurovascular bundle better than open surgery dose and enables faster recovery of continence with a comparable oncological outcome.[8]
According to one large retrospective study, performing RARP within 6 weeks of biopsy did not significantly influence surgical differences, efficacy, or oncological outcomes.[9] Nevertheless, to our knowledge, the results of historical studies remain controversial. Therefore, the aim of our study was to compare the impact of the time interval between prostate biopsy and RARP on surgical outcomes for localized prostate cancer in our institution.
Materials and MethodsFrom April 2016 to August 2019, 120 consecutive patients received RARP and pelvic lymph node dissection (PLND) by one experienced surgeon (VC Lin), with a high-volume on laparoscopic and robotic surgery. We retrospectively included the patients with localized prostate cancer in this study by searching the institutional database according to the regulations of the institutional review board in our hospital (name: Analysis of prognostic factor for the oncological outcome and complications of prostate cancer patients in Taiwan, number: EMRP-102-093, approval dated: July 1, 2021). We excluded patients who had advanced-stage (regional lymph nodes or distant metastasis) prostate cancer; neoadjuvant androgen deprivation therapy (ADT) before RARP; a history of adjuvant chemotherapy, radiotherapy (RT), and pelvic surgery for other diseases; or missing clinical, operative, and pathological data. Of those, we excluded 37 patients who had undergone TURP before because the procedure might impact functional and surgical outcomes. Finally, we included 83 patients in the study.
We carried out the RARP using the da Vinci Xi Surgical System via the extraperitoneal approach with PLND. We carried out either bilateral standard or extended PLND on all patients, depending on the National Comprehensive Cancer Network (NCCN) prostate cancer risk classification. For a high-risk group, we carried out extended PLND. For low- and intermediate-risk groups, we carried out standard PLND.
In brief, the surgical procedures are described as follows. With the patient in the Trendelenburg position, we inserted a size 20 French urinary catheter into the bladder. We employed a five-port technique. We made a 2 cm transverse incision infraumbilically, identified the anterior sheath of the rectus muscle, and then deepened to expose the posterior sheath. We created the preperitoneal space using the Spacemaker™ Dissection Balloon (Medtronic, Minneapolis, Minnesota, USA) and then inserted two 8 mm robotic trocars under finger guidance. After establishing the pneumopreperitoneum, we further dissected the space of Retzius using a traditional laparoscopic instrument and inserted the final two trocars (one 8 mm, one 12 mm).
After docking the robot, we carried out bilateral PLND. We incised the bilateral endopelvic fascia and controlled the dorsal vein complex (DVC) via suture ligation using a CT-1 needle, 1-0 Vicryl (Ethicon, Somerville, New Jersey, USA). We used monopolar scissors to transect the neck of the bladder and then pulled up both vas segments and seminal vesicles. We controlled bilateral pedicles using Hem-O-Lok (Teleflex Medical, Durham, NC). A nerve-sparing technique may be used to preserve both neurovascular bundles, depending on the preoperative biopsy results, erection function, and intraoperative status. We cut the DVC and prostate apex from urethra using cold scissors. We then entrapped the prostate with both seminal vesicles in an endobag and placed it in the right-hand retroperitoneal space cranially. We everted the bladder neck by interrupt sutures with 3 0 Chromic Catgut (Ethicon, Somerville, New Jersey, USA) and reconstructed the rhabdosphincter with a self-made double end RB-1 needle/3 0 Monocryl (Ethicon, Somerville, New Jersey, USA). The vesicourethral anastomosis is performed by a continuous suture with a self-made double end RB-1 needle/3-0 Monocryl suture (Ethicon, Somerville, New Jersey, USA). We infused 100 ml normal saline into the bladder to inflate it for a leakage test. If we found no leaks, the Foley catheter was to be removed on postoperative day six or seven. Otherwise, a cystogram was to be performed on postoperative day seven and the Foley was to be removed when no severe contrast medium extravasation was detected. If a leak was still noted, we would delay removal of the Foley for two extra days.
We divided patients into three groups based on the time interval between prostate biopsy and RARP (≤4 weeks, 4–8 weeks, and ≥8 weeks). According to the NCCN guideline, we stratified the patients into low-, intermediate-, and high-risk groups. Estimated blood loss, intraoperative transfusion rate, and operation time were considered to be perioperative outcomes, and they were representative of surgical difficulty. We recorded pathological status, including surgical margin status, lymphovascular invasion, extracapsular extension, seminal vesicle invasion, perineural invasion, days to remove urinary catheter, hospital days, postoperative erectile function score, and continence during the 1st year as being the parameters of postoperative outcomes. We defined urinary continence as the use of no more than one protective safety pad per 24 h, and potency was defined as erection hardness score (EHS) ≥3.
We used the Chi-square test and the Kruskal–Wallis test to evaluate the descriptive statistics of categorical variables. We used IBM SPSS software (version 22; IBM Corp., Armonk, NY, USA) for data analysis. P < 0.05 was considered statistically significant.
ResultsAs regards preoperative characteristics, the three groups displayed similarities. As regards intraoperative outcomes, we observed statistical difference only in the mean estimated blood loss (253.1 ml, vs. 158.9 ml, vs. 170.9 ml, P = 0.047). There was no significant difference between the three groups (221.9 min vs. 248.5 min vs. 226.7 min, P = 0.199). The detailed data are presented in [Table 1] and [Table 2].
Table 1: Preoperative characteristics stratified by time to robot-assisted radical prostatectomy
Table 2: Perioperative outcomes stratified by time to robot-assisted radical prostatectomyAs regards pathological outcomes, the three groups did not differ in pathological staging, positive surgical margin, lymphovascular invasion, extracapsular extension, seminal vesicle invasion, and perineural invasion. Furthermore, shorter time intervals between prostate biopsy and RARP did not correlate with prolonged days either to remove the urinary catheter (7.4 days vs. 7.3 days vs. 6.9 days, P = 0.361) or of hospitalization (9.8 days vs. 10.1 days vs. 9.4 days, P = 0.408), and we found that the patients in this group recovered total continence after 12 months' follow-up. The detailed data are presented in [Table 3].
Table 3: Postoperative outcomes stratified by time to robot-assisted radical prostatectomyAs regards sexual function, we observed no difference in decreased erectile hardness scores at 12 months' postsurgery between three groups (−0.75 vs. −0.77 vs. −0.57, P = 0.556). Overall, before the operation, 68.8% (11/16) of patients in the group with a time interval of ≤4 weeks, 48.7% (19/39) in the group with a time interval of 4–8 weeks, and 50% (12/28) in the group with a time interval of ≥8 weeks reported their EHS scores as being either 3 or 4. However, at 12 months' postsurgery, the percentages decreased to 37.5% (6/16), 23% (9/39), and 28.6% (8/28) in these groups, respectively. To deduce the relationship between RARP and postoperative impotence, we focused on the patients with a preoperative EHS ≥3 and a postoperative EHS <2. There were five cases in the group with a time interval of ≤4 weeks, ten cases in the group with a time interval of 4–8 weeks, and six cases in the group with a time interval of ≥8 weeks. Among the patients, there were 3, 5, and 3 cases received ADT or RT after RARP, respectively. The residual patients (2, 5, and 3) had hypertension, coronary artery disease, or diabetes mellitus, respectively. The detailed data are presented in [Table 4].
Table 4: Preoperative and postoperative erection hardness score stratified by time to robot-assisted radical prostatectomyComplication analysis showed that the groups did not differ significantly in respect of complication rates. Five patients in the group with a time interval ≥8 weeks had low-grade complications according to the Clavien–Dindo Classification. There were two cases of Grade III complications in the group with a time interval of ≤4 weeks, four cases in the group with a time interval of 4–8 weeks, and one case in the group with a time interval of ≥8 weeks. Furthermore, we found no increase of the postoperative complication rates in the shorter time interval groups. The detailed data are presented in [Table 5].
Table 5: Postoperative complications stratified by time to robot-assisted radical prostatectomy Discussion Biopsy of the prostate will cause inflammation of and bleeding between the prostate and surrounding tissue. Both the postoperative healing of the prostate and the inflammatory reaction to the biopsy reflect dissection difficulties.[10] During the operation, an inflammatory reaction increases the time taken and causes greater blood loss. If a patient wishes to undergo radical prostatectomy within a short period of time, the facility, efficacy, and oncological outcomes of the procedure are thought to be affected. Consequently, delaying radical prostate prostatectomy for at least 6–8 weeks after biopsy of the prostate has been considered to reduce inflammatory adhesion and hematoma. Such a delay could preserve the neurovascular bundle and avoid intraoperative rectal injury.[7] This recommendation has still been followed in the robotic era, but RARP is performed with clearer vision and more precise movements.[6] According to Martin et al., RARP within 6 weeks of biopsy is associated with a higher risk of complications.[6]
However, based on our clinical experience, the intervals between biopsy and RARP were not associated with significant differences in operative time; this might reflect the prostate's healing due to dissection difficulties or an inflammatory reaction to the biopsy. However, our study revealed that the group with a time interval of ≤4 weeks might experience greater blood loss, which could be considered as a surrogate of hemorrhage after the biopsy; it had a significant effect on the other two groups.[10] Even so, only one patient in our study received an intraoperative blood transfusion. As regards complications, we found five cases with a low-grade complication, including simple lymphocele, bulbourethral stricture, meatus stricture, chronic pelvic pain syndromes, and deep vein thrombosis, and all five cases were in the group with a time interval of ≥8 weeks. In all three groups, there were several cases with complicated lymphocele that required percutaneous drainage (Grade III complication), but these made no significant difference statistically.
Our study has gone far from the previous recommendation of delaying RARP for at least 6–8 weeks after biopsy. There are several reasons for this. First, compared with traditional surgery, the surgical field is magnified significantly during robotic surgery, and the surgeon can apply fine tissue dissection to better manage adhesion, improve bleeding control, and thereby reduce the transfusion rate.[6] Second, with the robot technique's improvement, we could promote a minimally invasive approach and lead to rapid recovery for the patients. Third, all the RARP procedures in this study were carried out by a surgeon with great experience of laparoscopic and robotic surgery. In our experience, the RARP program can be scheduled to begin immediately after shared decision-making with the patients and their families to avoid delayed treatment. Our study findings indicate that, unlike the previous recommendation, it is not necessary to postpone the RARP for 6–8 weeks after biopsy.
Some studies have reported findings similar to ours. Hirasawa et al. and Jo et al. reported that patients who received RARP in the short interval between biopsy and surgery did not differ significantly in many respects. In 2017, Hirasawa et al. reported that a prolonged time interval between biopsy and RARP did not have a substantial effect on the biochemical recurrence of prostate cancer. Therefore, there is no need to make hasty treatment decisions within 6 months after diagnosis of early prostate cancer.[11] Moreover, Jo et al. enrolled 1446 patients with localized prostate cancer and divided them into groups according to the time interval between biopsy to RARP, and time intervals of 2, 4, and 6 weeks did not affect either surgical difficulty or efficacy or oncological outcomes.
EHS is a single-item scale, and it shows favorable psychometric properties for assessing erectile function. It helps in evaluating erectile rigidity.[12] EHS was also considered correlated with self-confidence, self-esteem, and satisfaction with intercourse.[6],[11] However, RARP might also affect sexual function.[11] In this study, we checked preoperative and 1-year postoperative EHS, and we also tried to analyze the changes. Patients were regarded as having erectile function when their EHS ≥2. However, potency corresponded to EHS ≥3, which was defined as having an erection that was sufficient for intercourse.[13] Our study data showed that decreased EHS was generally found at 1-year post-RARP in all groups, even if there was no significant difference. We have tried to be more specific regarding the relationship between the procedure and sexual function, so we have focused on patients experiencing postoperative impotence, i.e., patients with preoperative EHS ≥3 and postoperative EHS <2. However, these three groups included few patients, and a large proportion of them were treated with either ADT or RT, which would be described the negative impact of erectile dysfunction.[14] Exclude the situation, the residual patients had underlying diseases that might also cause impotence.[15] From our data, the relationship between RARP and postoperative impotence has not yet been clarified.
In our study, the group with a time interval between prostate biopsy and RARP of ≤4 weeks experienced greater blood loss than did the other two groups. This was the only significant effect of the duration between biopsy and RARP that we observed. Of all 83 patients who were enrolled, only one patient in the group with an interval of ≤4 weeks received a blood transfusion during the operation. This group also displayed less operative time than did the other two groups, but the difference was not significant. A shorter time interval did not increase incontinence. In this study, we found no significant difference for pathological outcomes, postoperative outcomes (including the period of time either with a urinary catheter inserted or of hospitalization, and variation of sexual function), and complication analysis.
To summarize, our findings reveal that the recommendation of a delay of 6–8 weeks between biopsy and RARP may not be evidence-based medicine, and it is no longer necessary in the era of robotic surgery. Our results show RARP to be an effective and safe modality even when performed within 4 weeks after prostate biopsy. Moreover, the surgical timing of RARP could be eligible soon for patients who wanted to receive operation early.
Limitation
Our study has several limitations. First, it is a retrospective study, and it has selection and information bias. Second, our cohort was small, with a short follow-up time, and the study was performed in only one institution. Third, we adapted operative time and estimated blood loss as surrogate data for the degree of difficulty during operation, instead of criterion. Fourth, during the follow-up, we did not perform an echo on the patient with no symptoms to assess the lymphocele, and this may have led to underestimation of the rate of complications.
ConclusionsIn our experience, RARP can be performed both safely and effectively over different time intervals after prostate biopsy without either increasing total operative time or adversely compromising postoperative functionally and oncologic outcomes. However, performing RARP ≤4 weeks after prostate biopsy probably increased the risk of blood loss. Contrary to the previous recommendation, there is no need to delay RARP for 6–8 weeks after biopsy.
Financial support and sponsorship
Nil.
Conflicts of interest
Dr. Victor C Lin, an editorial board member at Urological Science, had no role in the peer review process of or decision to publish this article. The other authors declared no conflicts of interest in writing this paper.
References
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