Assessment of different continence definitions in the context of the randomized multicenter prospective LAP-01 trial-Does the best definition change over time?

BACKGROUND: A uniform definition of continence is urgently needed to allow the comparison of study results and to estimate patient outcomes after radical prostatectomy (RP). To identify a practical definition that includes both objective and subjective aspects in a tangible way, we assessed different continence definitions and evaluated which best reflects the patients' subjective perception of continence. METHODS: Our analyses included 718 patients that underwent either robot-assisted radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) in a multicenter randomized patient-blinded trial. Continence was assessed through patient questionnaires prior to and at 3, 6 and 12 months after surgery which included the number of pads used per day, the ICIQ-SF and the question "Do you suffer from incontinence? (yes/no)" to assess subjective continence. We used Krippendorff's Alpha to calculate the agreement of different continence definitions with the subjective perception. RESULTS: At 3 months, the "0/safety pad" definition shows the highest agreement by alpha = 0.70 (vs. 0.63 for "0 pads" and 0.37 for "0-1 pad"). At 6 and 12 months "0 pads" is the better match, with alpha values of 0.69 (vs. 0.62 and 0.31) after 6 months and 0.70 (vs. 0.65 and 0.32) after 12 months. The ICIQ-SF score shows good correlation with the subjective continence at 3 months (alpha = - 0.79), the coefficient then decreasing to - 0.69 and - 0.59 at 6 and 12 months. CONCLUSION: The best continence definition according to the patients' perspective changes over time, "0 pads" being the superior criterion in the long-term. We recommend using the 0-pad definition for standardized continence reporting, as it is simple yet as accurate as possible given the inevitably high subjectivity of continence perception. Trial registration The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

High BMI and Surgical Time Are Significant Predictors of Lymphocele after Robot-Assisted Radical Prostatectomy.

Lymphoceles (LC) occur in up to 60% after robot-assisted radical prostatectomy (RARP) and pelvic lymphadenectomy (PLND). In 2-10%, they are symptomatic and may cause complications and require treatment. Data on risk factors for the formation of lymphoceles after RARP and PNLD remain sparse in the urologic literature and are inconclusive to date. The underlying data of this secondary analysis were obtained from the prospective multi-center RCT ProLy. We performed a multivariate analysis to focus on the potential risk factors that may influence lymphocele formation. Patients with LC had a statistically significant higher BMI (27.8 vs. 26.3 kg/m2, p < 0.001; BMI ≥ 30 kg/m2: 31 vs. 17%, p = 0.002) and their surgical time was longer (180 vs. 160 min, p = 0.001) In multivariate analysis, the study group (control vs. peritoneal flap, p = 0.003), BMI (metric, p = 0.028), and surgical time (continuous, p = 0.007) were independent predictors. Patients with symptomatic lymphocele presented with higher BMI (29 vs. 26.6 kg/m2, p = 0.007; BMI ≥ 30 kg/m2: 39 vs. 20%, p = 0.023) and experienced higher intraoperative blood loss (200 vs. 150 mL, p = 0.032). In multivariate analysis, BMI ≥ 30 kg/m2 vs. < 30 kg/m2 was an independent predictor for the formation of a symptomatic lymphocele (p = 0.02). High BMI and prolonged surgical time are general risk factors for the development of LC. Patients with a BMI ≥ 30 kg/m2 had a higher risk for symptomatic lymphoceles.

Extended Pelvic Lymph Node Dissection Does Not Affect Functional Outcomes during Bilateral Nerve-Sparing Radical Prostatectomy.

INTRODUCTION: A possible association between extended pelvic lymph node dissection (ePLND) in radical prostatectomy (RPE) and functional outcomes such as erectile function (EF) and continence recovery has been previously considered. This association stems from the direct proximity of ePLND to the pelvic plexus. In this paper, we aimed to critically examine an association of ePLND with functional outcomes in patients who underwent bilateral nerve-sparing RPE. METHODS: 272 out of 782 patients from a randomized, patient-blinded, multicenter trial were retrospectively classified into two groups based on the D'Amico criteria: 114 had no PLND and 158 had ePLND. Continence (no pad/safety pad) and EF (Index of Erectile Function-5 [IIEF-5] questionnaire ≥17; sufficient erection for sexual intercourse) were assessed at 3, 6, and 12 months as well as postsurgical complications (Clavien-Dindo Classification). RESULTS: After 12 months of follow-up, no significant difference for potency could be found between men without and subjected to ePLND: IIEF-5 ≥17 (23.2% vs. 27.2%; p = 0.55) and sufficient erection for intercourse (44.1% vs. 45.6%; p = 0.84). A multiple linear regression analysis demonstrated that while preoperative EF (p < 0.001), pathological tumor stage (p = 0.027), and robot-assisted bilateral nerve-sparing RPE (p < 0.001) were independent predictors of EF recovery, the same did not apply to ePLND. No association was detected for continence recovery (94.2% vs. 89.7%; p = 0.22) and complications of any grade after surgery (11.4% vs. 16.5%; p = 0.24). CONCLUSION: ePLND is not associated with increased risk of erectile dysfunction, incontinence or complications after bilateral nerve-sparing RPE.

Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy.

PURPOSE: The purpose of this study was to investigate the effect of a surgically constructed bilateral peritoneal flap (PIF) as an adjunct to robot-assisted radical prostatectomy (RARP) and pelvic lymph node dissection (PLND) on the incidence of lymphoceles. MATERIALS AND METHODS: A total of 530 men with localized prostate cancer underwent a RARP with bilateral extended standardized PLND in a prospective randomized controlled trial. In group A, a PIF was created by suturing the margins of the bladder peritoneum to the ipsilateral endopelvic fascia at 2 points on each side. In group B, no PIF was created. The patients were followed 30 and 90 days after the surgery to assess the incidence, extent and treatment of lymphoceles. RESULTS: Lymphoceles occurred in 22% of group A patients and 33% of group B patients (p=0.008). Symptomatic lymphoceles were observed in 3.3% of group A patients and 8.1% of group B patients (p=0.027). Lymphoceles requiring intervention occurred significantly less frequently in group A patients (1.3%) than in group B patients (6.8%, p=0.002). The median lymphocele size was 4.3 cm in group A and 5.0 cm in group B (p=0.055). No statistically significant differences were observed in minor or major complications unrelated to lymphocele, blood loss, or surgical time between groups A and B. CONCLUSIONS: Bilateral PIFs in conjunction with RARP and PLND significantly reduce the total incidence of lymphoceles, the frequency of symptomatic lymphoceles and the rate of associated secondary interventions.

Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose?

OBJECTIVE: Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives. MATERIALS AND METHODS: LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads. RESULTS: 310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038). CONCLUSION: From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective. TRIAL REGISTRATION: The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

High-intensity focused ultrasound (HIFU) hemiablation of the prostate: Late follow-up MRI findings in non-recurrent patients.

OBJECTIVES: Focal therapy with high-intensity focused ultrasound (HIFU) is an emerging option for the treatment of prostate cancer and often followed up by MRI. Image assessment of treatment failure, however, requires proper knowledge about typical procedure-related changes in prostate MRI, which is sparse, in particular for unilateral HIFU treatment and late follow up (beyond 6 months). The goal of this study was therefore to compile the type and frequency of such MRI findings in selected patients without recurrent cancer 12 months after prostate hemiablation. METHODS: Data from a prospective multicenter trial on HIFU hemiablation were reviewed retrospectively. Trial patients have had a late follow-up by MRI (at around 12 months) and either MRI/transrectal ultrasound (TRUS) fusion or standard TRUS-guided biopsy. This work deliberately included patients with non-recurrent cancer in the treated prostate lobe in per-protocol biopsy leaving 30 men with initial International Society of Urological Pathology (ISUP) Grade Group of 1 or 2. Six categories of potential HIFU-related MRI features were assessed by an expert committee and then evaluated by two readers in consensus: 1. shrinkage of the treated lobe, 2. residual prostate tissue, 3. fluid-filled cavity, 4. fibrosis, 5. hematoma residuals (in the prostate or seminal vesicles) and 6. contrast enhancement of the ablated area. RESULTS: Shrinkage of the ablated lobe was seen in 93% of the cases with an average percent volume change of -37% (range: -70% to +108%). In the contralateral lobe, the volume remained practically the same (-2% on average, p = 0.804). In the ablated lobe, the frequency of fibrosis was 97%. Residual prostate tissue was seen in 93% of the cases. The frequency for fluid-filled cavities was 97%, with the wide majority (90%) contiguous with the urethra. Hematoma residuals in the prostate and in seminal vesicles were found in 47% and 10% of the patients, respectively. Contrast enhancement was both rim-like (50%) as well as diffuse (33%) within the ablated area. CONCLUSION: In our case series of HIFU hemiablation in the prostate, shrinkage, residual prostate tissue, fluid-filled cavities contiguous with the urethra and fibrosis were very common late MRI findings of the ablated lobe in non-recurrent patients. Rim-like contrast enhancement or diffuse one within the ablated area were less frequent.

Comparison of PI-RADS v1 and v2 for multiparametric MRI detection of prostate cancer with whole-mount histological workup as reference standard.

PURPOSE: The aim of this study was to compare Prostate Imaging Reporting and Data System (PI-RADS) versions v1 and v2 for the detection of prostate cancer (PCa) in multiparametric MRI (mpMRI) using whole-mount histological workup as reference standard. MATERIAL AND METHODS: MRI data of 40 patients with positive transrectal ultrasound-guided biopsy were analyzed retrospectively by two blinded readers (5 and 4 years' experience) with PI-RADS v1 and v2 for cancer-suspicious lesions. Prior to radical prostatectomy, patients had undergone IRB-approved mpMRI at 3 T according to PI-RADS recommendations: T2-weighted (T2w), diffusion-weighted (DWI) and dynamic contrast-enhanced (DCE) imaging. The reference standard was provided by whole-mount sections of the prostatectomy specimens. Versions v1 and v2 were compared with respect to sensitivity and positive predictive value (PPV) per lesion. Subgroups stratified by tumor location (peripheral vs. transition zone) and aggressiveness (high vs. low grade) were also analyzed. We also evaluated the concordance of the dominant MRI sequence in v2 (DWI or T2w) and the highest individual score under v1. Interobserver agreement for PI-RADS v1 and v2 was assessed by Cohen's kappa statistics. RESULTS: Reader 1 (R1) described 66 and Reader 2 (R2) 72 MRI lesions. The average Gleason score of 58 PCa lesions was 6.5 (range: 6 = 3 + 3 to 8 = 4 + 4), most of them (65.5%) located in the peripheral zone. PI-RADS v2 showed a trend towards lower sensitivities, but differences were not significant for both readers: R1 72.4% (v1) vs. 63.8% (v2) (P = 0.426) and R2 77.6% (v1) vs. 69.0% (v2) (P = 0.402). The trends were more pronounced in the transition zone and for low-grade cancers but remained insignificant (p-values from 0.313 to 0.691). Likewise, the apparent PPV differences, overall as well as in each zone, were not significant. Agreement between high-score v1 and dominant v2 sequence was 48% for R1 and 53% for R2. Cohen's κ of PCa detection for two readers was 0.48 for both v1 and v2. CONCLUSION: Our findings indicate that the simplified, zone-specific approach of PI-RADS v2 (2015) for MRI assessment of prostate cancer may not necessarily be better than the original v1 criteria (2012). In specific cases, a strict interpretation of v2 criteria may even lead to false-negative findings. Therefore, the current PI-RADS criteria should be reconsidered, despite the low statistical evidence here.

Four-point Peritoneal Flap Fixation in Preventing Lymphocele Formation Following Radical Prostatectomy.

BACKGROUND: Symptomatic lymphocele following radical prostatectomy (RP) and concomitant bilateral extended pelvic lymph node dissection (ePLND) has a significant impact on postoperative recovery and may sometimes require surgical intervention. OBJECTIVE: To report on the use of four-point peritoneal flap fixation (4PPFF) during RP to reduce lymphocele occurrence following PLND. DESIGN, SETTING, AND PARTICIPANTS: Between April 2010 and May 2017, 1358 patients underwent RP with concomitant bilateral ePLND. From this cohort, 193 patients who had undergone PNLD with 4PPFF were matched in a 1:1 ratio with respect to age, body mass index, initial PSA, and number of lymph nodes removed to patients who had undergone PLND without 4PPFF. INTERVENTION: 4PPFF was performed by suturing the cut end of the ventral parietal peritoneum at four points (to the anterior and lateral pelvic side wall on both sides) following PLND so that the peritoneal surface was exposed to the iliac vessels and obturator fossa. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All patients underwent ultrasound on postoperative days 6, 28, and 90 to test for the presence of lymphocele. For univariate analysis, a χ2 test and analysis of variance were applied, as appropriate. Statistical significance was set at p<0.05, and all p values reported were two-sided. RESULTS AND LIMITATIONS: There were no significant differences between the two groups with respect to intraoperative blood loss, positive surgical margin rate, Gleason score, clinical stage, and number of positive cores. Asymptomatic lymphocele was observed in four patients (2.07%) in the 4PPFF group compared to 16 patients (8.3%) without 4PPFF (p=0.0058). Similarly, a significant difference in the incidence of symptomatic lymphocele was observed: two patients (1.03%) in the 4PPFF group versus nine patients (4.6%) without 4PPFF (p=0.0322). There were no differences in other complication rates between the two groups. The limitations of the study are its retrospective and nonrandomised nature, with postoperative follow-up based on ultrasound imaging rather than computed tomography because of ethical considerations, which could have caused observer bias. CONCLUSIONS: 4PPFF is a safe and effective procedure in preventing lymphocele occurrence in patients undergoing RP with PLND. The increase in exposure of the PLND raw area to the peritoneal surface following this procedure may aid in increased absorption of accumulating lymph fluid. Further prospective randomised multicentre studies are warranted to confirm our observations. PATIENT SUMMARY: We report on the use of a surgical technique to decrease the collection of lymphatic fluid in the abdominal cavity following lymph node removal during radical removal of the prostate gland in patients with prostate cancer. Patients undergoing this procedure had significantly better outcomes when compared to patients operated on in the conventional approach.

Minimally invasive partial cystectomy with bilateral vesico-ureteric junction resection and reimplantation for a large paraganglioma involving urinary bladder trigone.

Paragangliomas are neuroendocrine tumours of extra adrenal origin. Although it occurs rarely in the genitourinary system, urinary bladder is the most common site. Its diagnosis warrants complete surgical excision with lymphadenectomy in case of metastatic disease. The functional status of this tumour makes intraoperative handling challenging. Surgical resection necessitates minimal manipulation of tumour thereby mitigating intraoperative physiological jeopardy. We report the possibility of minimally invasive partial cystectomy with bilateral vesico-ureteric junction resection and re-implantation for non-malignant paraganglioma involving the bladder trigone. Intraoperative frozen section is deemed necessary to achieve tumour free margin status.

Non-invasive estimation of prostate cancer aggressiveness using diffusion-weighted MRI and 3D proton MR spectroscopy at 3.0 T.

BACKGROUND: Clinical management of prostate cancer increasingly aims to distinguish aggressive types that require immediate and radical treatment from indolent tumors that are candidates for watchful waiting. This requires reliable and reproducible parameters to effectively control potential cancer progression. Magnetic resonance imaging (MRI) may provide a non-invasive means for this purpose. PURPOSE: To assess the value of diffusion-weighted imaging and proton MR spectroscopy for the prediction of prostate cancer (PCa) aggressiveness. MATERIAL AND METHODS: In 39 of 64 consecutive patients who underwent endorectal 3-T MRI prior to radical prostatectomy, prostate specimens were analyzed as whole-mount step sections. Apparent diffusion coefficient (ADC), normalized ADC (nADC: tumor/healthy tissue), choline/citrate (CC), and (choline + creatine)/citrate (CCC) ratios were correlated with Gleason scores (GS) from histopathological results. The power to discriminate low (GS ≤ 6) from higher-risk (GS ≥ 7) tumors was assessed with receiver operating characteristics (area under the curve [AUC]). Resulting threshold values were used by a blinded reader to distinguish between aggressive and indolent tumors. RESULTS: Ninety lesions (1 × GS = 5, 41 × GS = 6, 36 × GS = 7, 12 × GS = 8) were considered. nADC (AUC = 0.90) showed a higher discriminatory power than ADC (AUC = 0.79). AUC for CC and CCC were 0.73 and 0.82, respectively. Using either nADC < 0.46 or CCC > 1.3, as well as both criteria for aggressive PCa, the reader correctly identified aggressive and indolent tumors in 31 (79%), 28 (72%), and 33 of 39 patients (85%), respectively. Predictions of tumor aggressiveness from TRUS-guided biopsies were correct in 27 of 36 patients (75%). CONCLUSION: The combination of a highly sensitive normalized ADC with a highly specific CCC was found to be well suited to prospectively estimate PCa aggressiveness with a similar diagnostic accuracy as biopsy results.

Direct effects of vardenafil on the ureter: in vitro investigation and potential clinical applications of intralumenal administration.

Local intralumenal administration of substances with beneficial effects over the ureter appears to be a very attractive route for the administration of drugs to the urinary system, avoiding systemic adverse reactions associated with per os administration. This work investigates whether vardenafil is a good candidate for local intralumenal ureteral administration. More precisely, we examined the effect of vardenafil on human ureter contractility and on the viability of cultured human urothelial cells (hUC) and bladder smooth muscle cells (hBSMC). Our study revealed that vardenafil induced a dose-depended relaxation of isolated human ureteral tissue. In addition, growth and cell viability of cultured hBSMC and hUC remained unaltered after vardenafil application. Based on the above, this selective phosphodiesterase type 5 inhibitor can be considered as a promising pharmacologic agent for local intralumenal administration in clinical conditions in which ureteral dilation might be beneficial.

Evaluating the learning curve of experienced laparoscopic surgeons in robot-assisted radical prostatectomy.

BACKGROUND AND PURPOSE: Radical prostatectomy is the gold standard surgical treatment for organ-confined prostate cancer. There is no consensus on the impact of previous laparoscopic experience on the learning curve of robot-assisted laparoscopic prostatectomy (RALP). We compared the perioperative complications and early patient outcomes from our initial 100 cases of RALP with laparoscopic prostatectomy (LRP) cases performed well beyond the learning curve. PATIENTS AND METHODS: Between July 2011 and January 2012, 110 RALP were performed by one of two surgeons, each with previous experience of more than 1000 LRP. The cases were pair matched from among the last 208 patients who had undergone LRP by the same surgeons at the same time. The clinical parameters, operative details, postoperative complications, and short-term outcomes from these patients, collected prospectively, were compared between the two groups. RESULTS: The prostate-specific antigen (PSA) level and age of the two groups was similar. The operative time (128.4 vs 153.9 min; P=0.01) and blood loss (200 vs 254 mL; P=0.01) was significantly less for the LRP group, but the duration of catheterization was similar (5.89 vs 6.2 days). The complication rate was low. No procedures needed conversions, and no patient had a visceral injury or blood transfusion. Twenty-three patients in the LRP group and 33 patients in the RALP group had extraprostatic disease, and the positive margin rate was 14% and 19% for these respective groups. At 3 months, PSA level was undetectable in 94% of LRP and 92% RALP patients, while 56% and 65% (P=0.062) patients in these groups were using 0 to 2 pads per day. CONCLUSIONS: The initial results of the outcome of RALP are at least at par with those of LRP and with those of previously published RALP series. This suggests the lack of a steep learning curve for experienced laparoscopic surgeons in performing RALP.

Diagnostic value of ADC in patients with prostate cancer: influence of the choice of b values.

OBJECTIVES: To evaluate the influence of the choice of b values on the diagnostic value of the apparent diffusion coefficient (ADC) for detection and grading of prostate cancer (PCa). METHODS: Forty-one patients with biopsy-proven PCa underwent endorectal 3-T MRI before prostatectomy. Different combinations of b values (0-800 s/mm(2)) were used to calculate four representative ADC maps. Mean ADCs of tumours and non-malignant tissue were determined. Tumour appearance on different ADC maps was rated by three radiologists as good, fair or poor by assigning a visual score (VS) of 2, 1 or 0, respectively. Differences in the ADC values with the choice of b values were analysed using one-way ANOVA. RESULTS: Choice of b values had a highly (P < 0.001) significant influence on the absolute ADC in each tissue. Maps using b = [50, 800] and [0, 800] were rated best (VS= 1.6 ± 0.3) and second best (1.1 ± 0.3, P < 0.001), respectively. For low-grade carcinomas (Gleason score ≤ 6, 13/41 patients), only the former choice received scores better than fair (VS = 1.4 ± 0.3). Mean tumour ADCs showed significant negative correlation (Spearman's ρ -0.38 to -0.46, P < 0.05) with Gleason score. CONCLUSIONS: Absolute ADC values strongly depend on the choice of b values and therefore should be used with caution for diagnostic purposes. A minimum b value greater than zero is recommended for ADC calculation to improve the visual assessment of PCa in ADC maps. KEY POINTS: • Absolute ADC values are highly dependent on the choice of b values. • Absolute ADC thresholds should be used carefully to predict tumour aggressiveness. • Subjective ratings of ADC maps involving b = 0 s/mm ( 2 ) are poor to fair. • Minimum b value greater than 0 s/mm ( 2 ) is recommended for ADC calculation.

Comparison of the FreeHand® robotic camera holder with human assistants during endoscopic extraperitoneal radical prostatectomy.

OBJECTIVE: • To assess, in a prospective randomized study, the efficiency of the FreeHand® (Prosurgics Ltd, Bracknell, UK) compared to manual camera control during the performance of endoscopic extraperitoneal radical prostatectomy (EERPE). PATIENTS AND METHODS: • Three surgeons performed 50 EERPE for localized prostate cancer. In group A (n= 25), procedures were performed with manual control of the camera by the assistant, whereas group B (n= 25) patients were treated with the assistance of the FreeHand® robotic device. • The EERPE procedure was divided into several steps. • Total operation duration, time for each surgical step, number of camera movements, number of movement errors, number of times the lens was cleaned, blood loss and margin status were compared. RESULTS: • No statistically significant difference was observed in terms of patient age, preoperative prostate-specific antigen level, Gleason score, positive cores and prostate volume. • The average operation duration required for the performance of each step did not differ significantly between the two groups. • Significant differences in favour of the FreeHand® camera holder were observed in case of horizontal and zooming camera movement, camera cleaning and camera errors. • Vertical camera movements were performed significantly faster by the human assistant compared to the robotic camera holder. • The average total operation duration was similar for both groups. • Positive surgical margins were detected in one patient in each group (4% of the patients). CONCLUSIONS: • A comparison of the FreeHand® robotic camera holder with human camera control during EERPE showed a similar time requirement for the performance of each step of the procedure. • The robotic system provided accurate and fast movements of the camera without compromising the outcome of the procedure.