Prevention and Management of Complications During Robotic-assisted Laparoscopic Radical Prostatectomy Following Comprehensive Planning: A Large Series Involving a Single Surgeon

Discussion

This study analyzed the complication rates following RALP based on an analysis of 1,000 surgeries performed by a single surgeon and following perioperative evaluation and a defined clinical pathway. It revealed an overall complication rate of 6.4% and showed that complications were reduced from 12% to 4% after the surgeon and team gained experience, even among cases in whom the operative difficulty was increased. Major complications were reduced from 2.5% in the first 200 patients to 0.5% in the last 200 patients.

No studies on the relationship of complications and the operative difficulty of RALP have been performed to date. Patients in our cohort had a mean PSA level of 19.27 ng/ml and were at clinical stage >T3 (10.8%). After gaining more experience, the surgeon can treat more challenging and difficult cases. The Pasadena Consensus panel identified a subgroup of patients who should be treated only by an ‘experienced surgeon’, including obese patients (BMI >30 kg/m²), those with a large prostate volume (>70 g), patients with a large median lobe, cases with a previous TURP, high-risk patients requiring EPLND, and those who had had previous pelvic surgery (16). Only very experienced surgeons should perform SRP after radiation, cryotherapy, and high-intensity focused ultrasound (17). We modified the criteria for difficult cases by including the presence of a large median lobe of the prostate with an intravesical lobe protruding >1 cm. Patients with a protruding medial lobe >1 cm had significantly more base surgical margin positivity than patients with a <1-cm protruding medial lobe (35.9% vs. 20.1%, p=0.012) (18). In our experience, cases with NHT had more adhesion around the periprostatic tissue plane. NHT significantly increased the operative time required for RALP (254 min vs. 209 min, p=0.019) compared with the time required for patients without NHT (19).

We expanded the indication of RALP for more complicated cases after we gained experience. After the first 200 cases of RALP, we performed surgery in more difficult cases; for example 8% of later cases had undergone previous TURP, which had caused more rectal injury and major complications, compared with no previous TURP in earlier patients (16). Clavien IV major complications of bowel problems occurred in the first 200 cases, for example, unrecognized sigmoid colonic injury and recto-urethral fistula (3). After the team learned during the first 200 cases of RALP, no more rectal injuries occurred. After the team had gained experience, the outcomes among patients who had undergone previous TURP, had a large median lobe >1 cm, had undergone previous pelvic surgery, and had SRP were not statistically different from those of patients who had not had these intervention. The ratio of patients with NHT, BMI >30 kg/m², or prostate volume >70 g compared to other patients in the group were significantly increased in each 200-case interval (Table IV). The question is do challenging cases incur more complications? From our data, we believe that safe RALP, even among cases that present greater operative difficulty, depends on comprehensive preoperative planning performed by a dedicated robotic team and proper postoperative care.

Coelho et al. reviewed the complication rates following RALP in a high-volume center and reported complication rates from 4.4% to 22%, and major complication rates from 0.6% to 8.5% (4). They reported a single-surgeon series that involved 2500 cases of RALP, and the complication rate was 5.08%; complications decreased from 9.3% in cases 1-300 to 3.3% in cases 2101-2400 (4). Liss et al. reported an overall complication rate of 10.8% (108 out of 1000) among RALP cases (20). The overall complication rate was reduced from 18% in the first 200 cases to 5% in the last 200 cases. Major complications (grades III and IV) were reduced from 12.5% to 2.5% (20). The surgeon provided targeted changes in the technique to reduce complications during surgery and achieved statistically significant reductions in corneal abrasions, fossa navicularis strictures, and camera-site hernias (19). The majority of complications occurred during treatment of the early cases. Cheng et al. reported that an early case series with 79 cases (45 with laparoscopic radical prostatectomy and 34 with RALP) had a 43% overall complication rate and a 7.6% rate of major complications (21). However, the overall mortality of the RALP series was very low (0.1-0.2%) (3, 7, 20).

Preoperative drugs administered to patients included anticoagulants, Chinese herbs, and drugs to treat hyperuricemia or gouty arthritis. In our practice, it is mandatory for all patients to withhold anticoagulants 1 week before RALP and to withhold Chinese herbs 3 weeks before RALP. Mantz et al. reported that elective noncardiac surgery (including urological surgery) can be performed safely following continuous administration of antiplatelet agents (22). They did not find a significant difference in terms of occurrence of major thrombotic or bleeding events between patients who continued or discontinued or interrupted their intake of aspirin (22). Some Chinese herbal preparations can protract clotting time by disruption of the coagulation cascade (23). Patients who consume Chinese drugs have elevated risks and can experience severe adverse effects due to potential drug interactions and thus should be investigated preoperatively (24). Cordier and Steenkamp suggested that herbal preparations should be discontinued before patients receive any surgical procedure (23). Gout attack occurred in 4.2% of 359 patients with prostate cancer who underwent radical prostatectomy (open, laparoscopic, or robotic) (20). In our experience, the incidence of gouty arthritis attack was 1.5% in the first 200 cases but decreased to 0.375% in the subsequent 800 cases because we administered preventive medication for hyperuricemia (3).

MRI is increasingly used to study prostate cancer and improves staging, identifiction of spatial anatomic features, and determination of aberrant structures (25). For regional staging, MRI can help predict the site of tumor extracapsular extension and apical tumor to reduce the positive surgical margin (18, 26). MRI can help surgeons to preserve the neurovascular bundle and determine the extent of surgical margins in RALP (27). Because it provides spatial anatomic information about the prostate diameter and the pelvic cavity, MRI can be used to predict the surgical difficulty (operation time, EBL, transfusion rate, and surgical margin positivity) of RALP (28). In the case of aberrant structures, prior MRI can allow surgeons to repair subclinical inguinal hernia and preserve anomalous accessory pudendal arteries (25, 29). A surgeon's prior knowledge about the anatomy of the patient's prostate, pelvis, and surroundings is valuable and can expedite precise dissection, resection of the prostate, preservation of the neurovascular bundle, and vesicourethral anastomosis. Likewise, surgeons depend on information from MRI to operate safely, shorten the operative time, facilitate rapid recuperation, reduce complications, and improve outcomes. Table IV compares results from the first 200 patients and outcomes from the last 200 patients and shows that the console time was reduced by 36.6%, EBL was reduced by 45.5%, the transfusion rate was reduced by 85.7%, the complication rate was reduced by 66.7%, and the rate of major complications was reduced by 60%. MRI benefits both inexperienced surgeons and those who have more experience. Reducing complications involves multiple types of learning and is a life-long learning process. For the Authors, a dedicated robotic team performed every step of RALP, including patient positioning, protection, trocar setting, and wound closure. Such a setting provides a fast learning experience, expedites proficiently, reduces complications, and improves outcomes as experience is accumulated (3).

The clinical care pathway provides evidence that supports clinical decision-making (30). We abide by the clinical care pathway for RALP. Any deviation from the normal postoperative course and clinical care pathway, requires early diagnosis with a computed tomographic scan and subsequent management of complications. The most common complications in our series were blood transfusions and bowel problems. During the course of our work, the blood transfusion rate was gradually reduced. Several authors have reported that urine leaks are the most common complication and have an incidence from 0.3% to 15.4% (8, 31). The sequelae of urine leaks can involve vesicourethral anastomotic strictures and incontinence. In our series, the incidence of urine leak was 0.6% (6/1000: Clavien score I in four patients and Clavien score II in two). Our method of vesicourethral anastomosis involved posterior reconstruction of the rhabdosphincter (32) and intraoperative bladder challenge with normal saline (200 ml) with bladder compression (33). Coelho et al. compared 473 patients with modified posterior reconstruction of the rhabdosphincter and 330 without posterior reconstruction following RALP. The anastomotic leakage rate was only 0.4% in posterior reconstruction-treated patients and was associated with early recovery of continence but was 2.1% in patients without posterior reconstruction (32). In our series, after the security of the watertight vesicourethral anastomosis was confirmed intraoperatively, there was no need for postoperative cystography (33).

One study reported a series of 79 cases who underwent laparoscopic radical prostatectomy and 34 who received RALP by multiple surgeons, and the total complication rate was 43% (21). The complication rate was larger in early cases that involved multiple surgeons. Our series showed low complication rates from a high-volume surgeon who performed the RALP. These results cannot be generalized to earlier experiences and series that involve multiple surgeons. The strengths of our study include the prospectively collected data and standardized reports using the Clavien system, and we complied with 9 out of 10 criteria set out by Martin et al., except for the risk factors in the analysis (5). These results can provide valuable information for comparisons with other series of RALP and suggest how to prevent and deal with complications.