3 research outputs found
Long-Term Follow-Up of Peritoneal Interposition Flap in Symptomatic Lymphocele Reduction following Robot-Assisted Radical Prostatectomy: Insights from the PIANOFORTE Trial
The available randomised controlled trials (RCTs) assessing the influence of peritoneal
interposition flaps (PIF) on the reduction of symptomatic lymphoceles (sLCs) post robot-assisted
radical prostatectomy (RARP) do not constitute a sufficient follow-up (FU) to assess the long-term
effects. The PIANOFORTE trial was the first of these RCTs, showing no sLC reduction at the 3-month
FU. Therefore, all 232 patients from the PIANOFORTE trial were invited for long-term FU. One
hundred seventy-six patients (76%) presented themselves for FU and constituted the study group
(SG). The median FU duration was 43 months. No significant differences in group allocation or LC
endpoints at 90 days were observed between SG patients and patients not presenting themselves for
the FU. During the FU period, four patients (2.3%) in the SG developed sLCs, and six patients (3.4%)
developed asymptomatic lymphoceles (aLCs), which persisted in five patients (2.9%). There were no
significant differences between PIF and non-PIF regarding sLC/aLC formation or persistence, newly
developed complications, stress urinary incontinence or biochemical/clinical tumour recurrence.
Therefore, this long-term FU confirms the primary outcomes of the PIANOFORTE trial that, while
PIF does not impact complications or functionality, it does not reduce sLC/aLC rates. Furthermore, it
shows the potential occurrence of LC after the third postoperative month
Peritoneal Flap in Robot-Assisted Radical Prostatectomy
Background: Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired. Methods: A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115. Results: The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486). Conclusion: A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment
High BMI, Aggressive Tumours and Long Console Time Are Independent Predictive Factors for Symptomatic Lymphocele Formation after Robot-Assisted Radical Prostatectomy and Pelvic Lymph Node Dissection
Introduction:
Lymphocele (LC) formation is a common complication which may cause severe symptoms after robot-assisted radical prostatovesiculectomy (RARP) with concomitant pelvic lymph node dissection (PLND). Compared to open radical prostatectomy, the amount of data on potential risk factors for LC formation is still limited. The aim of the present study was to identify risk factors for symptomatic LC formation (sLC) after RARP with PLND.
Methods:
We used the data of a prospective multicentre series of 232 RARP patients which were treated between March 2017 and December 2017. The primary endpoint was the presence of sLC within 90 days. Asymptomatic LC (aLC) formation was also recorded. We evaluated clinical, perioperative, and histopathological criteria and compared their distribution in patients with and without post-operative sLC. Uni- and multivariable logistic regression analyses (MVAs) were performed to identify potential predictors for LC formation. Regarding the influence of patients’ BMI, 2 models were calculated: BMI continuously (model 1) and BMI dichotomized with cut-off 30 kg/m2 (WHO definition, model 2).
Results:
Post-operative sLC was present in 21 patients (9.1%), while aLC was detected in 49 patients (21.1%) 90 days after RARP with PLND. Patients with sLC showed higher median baseline PSA levels (9.8 vs. 8.1 ng/mL), higher prevalence of obesity (BMI >30; 42.9 vs. 19.9%), and longer median console time (180 vs. 165 min) compared to patients without sLC. On MVA higher BMI {model 1: OR 1.145 (confidence interval [CI] 1.025–1.278); model 2: OR 2.761 (1.045–7.296)}, longer console time (model 1: OR 1.013 [1.005–1.021]; model 2: OR 1.013 [1.005–1.020]) and an ISUP grade ≥3 (model 1: OR 3.247 [1.182–8.917]; model 2: OR 2.791 [1.050–7.423]) were identified as independent predictors for sLC development.
Conclusion:
Patients with aggressive tumours and higher BMI should be informed about a potentially increased risk for sLC formation. In case of a long console time, a close and regular follow-up should be considered to check for LC development