The lack of standardized reporting of the complications of radical prostatectomy in the literature has made it difficult to compare incidences across institutions and across different surgical approaches.
Objective
To define comprehensively the incidence, severity, and timing of onset of medical and surgical complications of open retropubic prostatectomy (RP) and laparoscopic radical prostatectomy (LP) using a standardized reporting methodology to facilitate comparison.
Design, setting, and participants
Between January 1999 and June 2007, 4592 consecutive patients underwent RP or LP without prior radiation or hormonal therapy. Median follow-up was 36.9 mo (interquartile range: 20.3–60.6).
Intervention
Open or laparoscopic radical prostatectomy.
Measurements
All medical and surgical complications of radical prostatectomy were captured and graded according to the modified Clavien classification and classified by timing of onset.
Results and limitations
There were 612 medical complications in 467 patients (10.2%) and 1426 surgical complications in 925 patients (20.1%). The overall incidences of early minor and major medical and surgical complications for RP were 8.5% and 1.5% for medical and 11.4% and 4.9% for surgical complications, respectively. The overall incidences of early minor and major medical and surgical complications for LP were 14.2% and 2.3% for medical and 23.1% and 6.6% for surgical complications, respectively. On multivariate analysis, LP approach was associated with a higher incidence of any grade medical and surgical complications but a lower incidence of major surgical complications than RP. Six hundred fifty-two men (14.2%) visited the emergency department, and 240 men (5.2%) required readmission. The main limitation is the retrospective nature.
Conclusions
With standardized reporting, the incidence of some complications is higher than recognized in the literature. Although most complications are minor in severity, medical and surgical complications are observed in approximately 10% and 20% of patients, respectively. Accurate reporting of complications through a standardized methodology is essential for counseling patients regarding risk of complications, for identifying modifiable risk factors, and for facilitating comparison across institutions and approaches.
Introduction
With the introduction of laparoscopic radical prostatectomy (LP) and robot-assisted LP (RARP), there have been a number of publications comparing these more recent techniques to open radical retropubic prostatectomy (RP) [1], [2], [3], [4], [5], [6]. Differences in patterns of practice make comparison of complications across different approaches difficult and even more challenging across different institutions. To facilitate comparison of complication rates, consistency and clarity in reporting is necessary, as some authors have advocated [7].
The more widespread use of grading schemes [8] in reporting complications has facilitated standardization to some degree. Martin et al [7] have identified 10 critical elements of accurate and comprehensive reports of surgical complications (Appendix A). Although capture of all complications may be impossible in a retrospective study due to poor documentation, even in prospective studies [1], some complication categories may not be reported. A review of the studies evaluating complication rates in the urologic oncology literature reported that only 2% met 9 or 10 of Martin et al's criteria and 21% met 7 or 8 criteria. The most commonly underreported criteria were complication definitions, complication severity/grade, outpatient data, comorbidities, and duration of the reporting period [9].
We sought to apply the standards set forth by Martin et al [7] in performing a comprehensive report on the complications of radical prostatectomy at our institution in an effort to encourage the use of standardized reporting in the literature and, thus, to facilitate comparison across institutions and surgical approaches and to aid in patient counseling.
Section snippets
Patients and methods
Between January 1999 and June 2007, 4592 consecutive patients underwent radical prostatectomy (RP or LP) for adenocarcinoma of the prostate at our institution. Patients undergoing LP received low-molecular-weight heparin starting before surgery and continued daily until discharge; patients undergoing RP did not routinely receive low-molecular-weight heparin but had sequential compression boots.
Data were collected from a prospective prostatectomy database together with a prospective
Patient population
Table 1 summarizes the clinical characteristics of the 4592 patients by prostatectomy approach with open RP performed in 3458 men (75.3%) and LP (including 97 RARP cases) in 1134 men (24.7%). Prior treatment in 246 patients consisted of prior chemotherapy (n = 45) or hormonal therapy (n = 224). Median patient age was 59.5 yr (interquartile range [IQR]: 54.7–64.2). The patient population was generally healthy, with an ASA score ≤2 in 4007 men (87.3%) and a modified Charlson score <2 in 2076 men
Discussion
With the introduction of any surgical technique, there is a need to evaluate the complication rate in a sound and consistent manner to allow comparison across institutions and across different approaches. In a review of 119 articles in the surgical literature, Martin et al [7] developed 10 criteria to judge the quality of complication reporting. Of the 10 criteria, no articles met all criteria, 2% met 9 criteria, and 38% met 7 or 8 criteria; 52% met ≤4 criteria. In the present study, we have
Conclusions
Using standardized criteria, medical and surgical complications were present in 8.8% and 18.7% of RP patients, respectively, and in 14.5% and 24.5% of LP patients, respectively. Although best examined prospectively, these findings may be useful to counsel patients, to identify potentially modifiable risk factors, and to facilitate comparisons between institutions and techniques. With further standardized reporting from multiple institutions, a risk stratification scheme may be able to be
Point pratique sur la stratégie thérapeutique de la prise en charge des fistules urétro-rectales (FUR) après traitement de cancer de prostate localisé.
Analyse de la littérature (PubMed, Cochrane Database) des articles en langue anglaise et française portants sur les FUR.
Les FUR après prise en charge de cancer de prostate sont rares. Le bilan paraclinique (cystoscopie, uréthrocystographie, IRM pelvienne) permet de les classer en simple et complexe. Les FUR complexes, de diamètre > 2 cm, les antécédents d’irradiation, les sepsis à répétition et la fécalurie sont des facteurs de mauvais pronostic. Le traitement conservateur ne doit pas excéder 3 mois et fait appel à une dérivation urinaire, parfois associée à une dérivation digestive en cas de présence de plusieurs facteurs de mauvais pronostic. La voie trans périnéale semble apporter les meilleurs résultats chirurgicaux et de bons résultats fonctionnels.
La prise en charge des FUR peut être initialement conservatrice. La prise en charge chirurgicale doit être discutée avec le patient en prenant en compte son état général et les résultats escomptés.
Practical point relating to the management of rectourethral fistula (RUF) after localized prostate cancer treatment.
Review of literature (PubMed, Cochrane Database) of articles in French and English regarding RUF.
RUF after localized prostate cancer treatment are rare. Paraclinical examinations (cystoscopy, uretrocystography, RMI) permit the classification between simple and complex. Complex RUF, of > 2 cm diameter, history of irradiation, repetitive sepsis, fecaluria, are poor prognosis factors. A conservative approach may not exceed 3 months, and consist in a urinary diversion, sometimes associated with a digestive one in case of several poor prognosis factors. The trans perineal approach seems to have the best surgical results, and favorable functional outcomes.
RUF management may initially be conservative. Surgical treatment must be discussed with the patient in the light of his general condition and the expected outcomes.
The objective of the French Urology Association Cancer Committee is to propose an update of the recommendations for the diagnosis and management of prostate cancer (PC).
A systematic review of the literature from 2020 to 2022 was conducted by the CCAFU on the diagnosis and therapeutic management of localised PC, while evaluating the references and their levels of evidence.
The recommendations specify the genetics, epidemiology and means of diagnosing prostate cancer, as well as the notions of screening and early detection. MRI, the gold standard imaging examination for localised cancer, is recommended before prostate biopsies are performed. The transperineal approach reduces the risks of infection. The therapeutic methods are described and recommended according to the clinical context. Active surveillance is the gold standard of treatment for tumours with a low risk for progression. Early salvage radiotherapy is recommended in case of biochemical recurrence after radical prostatectomy. Imaging, particularly molecular imaging, helps to guide the decision-making in the event of biochemical recurrence after local treatment, but should not delay early salvage radiotherapy in the event of biological recurrence after radical prostatectomy.
This update of the French recommendations should help to improve the management of patients with PC.
Le but du Comité de Cancérologie de l’Association française d’urologie est de proposer une mise à jour des recommandations dans le diagnostic et la prise en charge du cancer de la prostate (CaP).
Une revue systématique de la littérature de 2020 à 2022 a été conduite par le CCAFU concernant les éléments de diagnostic et de prise en charge thérapeutique du CaP localisé, en évaluant les références avec leur niveau de preuve.
Les recommandations précisent la génétique, l’épidémiologie et les moyens diagnostiques du cancer de la prostate, les notions de dépistage et de détection précoce. L’IRM, examen d’imagerie de référence du cancer localisé, est recommandée avant la réalisation de biopsies prostatiques. La voie transpérinéale permet de réduire les risques infectieux. Les moyens thérapeutiques sont détaillés, et recommandés en fonction des situations cliniques. La surveillance active est le traitement de référence pour les tumeurs de faible risque évolutif. La radiothérapie de rattrapage précoce est recommandée en cas de récidive biologique post-prostatectomie totale. L’imagerie, notamment moléculaire, permet d’orienter la prise de décision en cas de récidive biologique après traitement local, mais ne doit pas retarder la radiothérapie de rattrapage précoce en cas de récidive biologique post-prostatectomie totale.
Cette actualisation des recommandations françaises doit contribuer à améliorer la prise en charge des patients porteurs d’un CaP.
Transperineal repair of rectourethral fistula (RUF) following prostate cancer treatment with gracilis muscle flap interposition (GMFI) leads to favourable outcomes, but published data are still lacking, notably concerning functional aspects.
To assess surgical and functional outcomes of this treatment of RUF.
A retrospective study was conducted in two referral hospitals including 21 patients who underwent RUF transperineal repair with GMFI between 2008 and 2020.
The standard vertical perineal approach is performed for fistula dissection. Bladder and rectal defects are closed separately. After dissection from its facia, the flap is harvested, preserving its pedicle; it is brought to the perineum and placed between the urethra and the rectum to fully cover the sutures.
Fistula closure (clinical data and postoperative cystography), digestive stoma closure, and complications graded according to the Clavien-Dindo classification were reviewed. Functional results were assessed using the Urinary Symptom Profile (USP) questionnaire, anal incontinence St Mark’s score, Patient Observer Scar Assessment Scale (POSAS) score, and a nonvalidated Likert scale questionnaire assessing issues with lower extremity functionality.
The median (interquartile range) follow-up was 27 (8–47) mo. Fistula closure was successful for 20 patients (95% success). Digestive stoma was closed in 10/12 shunted patients (83%). Two (9%) Clavien-Dindo grade ≥3b complications were reported (one urinoma in a kidney transplant patient and one thigh haematoma evacuation). Eighteen patients (86%) completed the postoperative questionnaire; 11/18 (61%) had significant urinary incontinence. The mean (standard deviation) USP dysuria score was 1/9 (1.2), mean St Mark’s score was 5/24 (5), mean POSAS score was 19/70 (11), mean lower extremity functionality score was 2/20 (4), and mean procedure patient satisfaction score was 9/10 (2). The retrospective design and limited number of patients are the main limitations.
The present study found an excellent success rate and low morbidity for RUF transperineal repair with GMFI. Functional outcomes were satisfactory despite a high urinary incontinence rate.
We performed an analysis of the outcomes of perineal approach surgery with muscle interposition for closing abnormal communication between the bladder and the rectum after prostate cancer treatment. This surgical technique was found to be safe to perform and provides a high success rate, with patients being satisfied despite poor urinary continence outcomes.
Objectif. Le but du Comité de cancérologie de l’Association française d’urologie est de proposer une mise à jour des recommandations dans la prise en charge du cancer de la prostate.
Méthodes. Une revue systématique (Medline) de la littérature de 2018 à 2020 a été conduite par le CCAFU concernant les éléments du diagnostic, les options de traitement et la surveillance du cancer de la prostate, en évaluant les références avec leur niveau de preuve.
Résultats. Les recommandations précisent la génétique, l’épidémiologie et les moyens diagnostiques du cancer de la prostate, les notions de dépistage et de détection précoce. L’imagerie par résonance magnétique (IRM), examen d’imagerie de référence du cancer localisé, est recommandée avant la réalisation de biopsies prostatiques. Les moyens thérapeutiques sont détaillés et recommandés en fonction des situations cliniques. La surveillance active est une option thérapeutique de référence pour les tumeurs de faible risque évolutif. La radiothérapie de rattrapage précoce est recommandée en cas de récidive biologique postprostatectomie totale. La suppression androgénique (SAd) reste le traitement de fond au stade métastatique. Le docétaxel associé à la SAd améliore la survie globale en première ligne du cancer de la prostate métastatique synchrone. Dans cette situation, l’association de la SAd à l’abiratérone est également un standard thérapeutique quel que soit le volume tumoral. Les données récentes amènent à recommander la SAd à une hormonothérapie de nouvelle génération (apalutamide ou enzalutamide) chez les patients métastatiques synchrones ou métachrones, quel que soit le volume tumoral. Le traitement local du cancer de la prostate par radiothérapie améliore la survie des patients oligométastatiques synchrones. Le traitement ciblé des métastases est en cours d’évaluation. Chez les patients présentant un cancer de la prostate résistant à la castration (CPRC), l’apport des nouvelles thérapies qui ont émergé ces dernières années aide à mieux contrôler la progression tumorale et à améliorer la survie.
Conclusion. Cette actualisation des recommandations françaises doit contribuer à améliorer la prise en charge des patients porteurs d’un cancer de la prostate.
Objective. - The purpose of the guidelines national committee ccAFU was to propose updated french guidelines for prostate cancer.
Methods. - A Medline search was achieved between 2018 and 2020, as regards diagnosis, options of treatment and follow-up of prostate cancer (PCA), and to evaluate the different references specifying their levels of evidence.
Results. - The guidelines outline the genetics, epidemiology and diagnosis of prostate cancer, as well as the concepts of screening and early detection. MRI, the gold standard imaging test for localized cancer, is indicated before prostate biopsies are performed. The therapeutic methods are detailed and indicated according to the clinical situation. Active surveillance is a reference therapeutic option for low-risk tumours with a low evolutionary risk. Early salvage radiotherapy is indicated in case of biological recurrence after radical prostatectomy. Androgen deprivation therapy (ADT) remains the backbone therapy in the metastatic stage. Docetaxel in combination with ADT improves overall first-line survival in synchronous metastatic prostate cancer. In this situation, the combination of ADT with abiraterone is also a standard of care regardless of tumor volume. Recent data indicate that ADT should be indicated with a new generation of hormone therapy (Apalutamide or Enzalutamide) in metastatic synchronous or metachronous patients, regardless of tumour volume. Local treatment of prostate cancer with radiotherapy improves survival in synchronous oligometastatic patients. Targeted treatment of metastases is being evaluated. In patients with castration-resistant prostate cancer (CRPC), new therapies that have emerged in recent years help to better control tumor progression and improve survival.
Conclusion. - These updated french guidelines will contribute to increase the level of urological care for the diagnosis and treatment for prostate cancer.
The success of this system is linked to its logical design and reproducibility. The Clavien-Dindo system (CDS) has previously been applied in urological surgery [6–12]. Various authors have reported limitations when using the CDS to grade intraoperative AIs [7,11–13] as it was originally designed to report postoperative complications.
A surgical adverse incident (AI) is defined as any deviation from the normal operative course. Current complication-grading systems mostly focus on postoperative events.
To propose an intraoperative AI classification (EAUiaiC) to facilitate reporting.
The classification was developed using a modified Delphi process in which experts answered two rounds of survey questionnaires organised by the European Association of Urology ad hoc Complications Guidelines Panel. Experts evaluated AI terminology using a 5-point Likert scale for clarity, exhaustiveness, hierarchical order, mutual exclusivity, clinical utility, and quality improvement.
We considered ≥70% agreement for inclusion or exclusion. The resultant EAUiaiC was evaluated using ten sample clinical scenarios. Numerical and graphical statistical techniques were used to report the results.
In total, 343 respondents participated. The proposed EAUiaiC system comprises eight AI grades ranging from grade 0 (no deviation and no consequence to the patient) to grade 5B (wrong surgery site or intraoperative death). In the validation stage, EAUiaiC was rated highly favourably in terms of relevance and reliability (consistency) by 126 experts. Ratings for self-reported ease of use were at acceptable levels.
We propose a novel intraoperative AI classification (EAUiaiC) for use for urological procedures. Both the initial assessment of feasibility and the subsequent assessment of reliability suggest that it is a simple and effective tool for classifying intraoperative complications.
Complications in surgery are common. It is helpful to classify complications in a uniform and objective manner so that surgeons can easily compare outcomes and learn from complications. Here we propose a new classification system for complications that occur during urological surgical procedures.
An abstract of this work was presented at the 2018 congress of the European Association of Urology.
2020, Urologic Oncology: Seminars and Original Investigations
To impartially optimize complication reporting in patients after open radical prostatectomy (ORP) and pelvic lymph node dissection (PLND) by adopting the modified Bern Comprehensive Complication Index (CCI). ORP and PLND are associated with relevant postoperative morbidity. The CCI—ranging from 0 (no complications) to 100 (death)—is a tool that aims to integrate all complications occuring within 90 days postoperatively weighted by severity in a single formula.
In an observational single-center cohort, 90-day postoperative complications of 1,123 consecutive patients undergoing standardized ORP and PLND between 1996 and 2017 were evaluated. Prospectively collected complications were graded according to the Clavien-Dindo Classification. Grade I to II complications were defined as minor and grade IIIa to V as major. Finally, the recently developed modified Bern CCI using an exponential function, which transforms the sum of the weights into a value between 0 and 100 and the original CCI for each patient were extracted and compared. The correlation between the modified Bern and original CCI values was depicted graphically.
The complication rate was 42%, with 18% minor and 24% major complications. With the original CCI, the threshold of 100 was exceeded in 1 patient who had a maximal index value of 101 within 90d postoperatively. The maximal value of the Bern CCI was 97.5. Mean Bern and original CCI scores and standard deviations were 6.2 (11.3) and 7.6 (12.2) at 30 days, and 9.3 (13.9) and 10.7 (14.2) at 90 days.
The Bern CCI provides a more precise depiction of postoperative morbidity and represents the burden in patients with >1 complication after ORP and PLND more accurately than the original CCI allowing for a more reliable evaluation of quality of care and recovery. It therefore warrants consideration for standardized reporting of complications after ORP and PLND.
