[Pre- and post-prostatectomy rehabilitation by the certified nurse-urologist pair (REHAB): Feasibility study]. / Parcours de réhabilitation par le binôme IDE-urologue avant et après prostatectomie (REHAB) : étude de faisabilité.

INTRODUCTION: The functional results of radical prostatectomy are a crucial issue for patients to resume fulfilling sexuality. We assessed the feasibility of a care pathway dedicated to sexual rehabilitation in order to improve information, screening of risk situations and the implementation of therapeutic measures. METHODS: From January to May 2023, sexually active patients under 75 years of age undergoing prostatectomy for cancer were offered the opportunity to participate in two sexual rehabilitation sessions (REHAB) led by a nurse-urologist pair. The sessions took place in parallel with the care pathway already in place before and after surgery. The evaluations were carried out by carrying out questionnaires and a clinical examination. A satisfaction questionnaire was given to the patient after the two sessions to assess the format and relevance of the sessions. RESULTS: Fifteen patients were included in the REHAB program. All patients attended both sessions in person and the majority of them (91%) felt they had obtained new information for their rehabilitation. Post-operatively at 6 weeks, 82% of patients were dissatisfied with their sexuality (compared to 64% pre-operatively), Five patients (33%) had regained orgasmic abilities and 20% (n=3) had a penetrative ability. The average IIEF5 score was 19 (6-28) compared to 22.5 pre-operatively (14-30). All patients would recommend these sessions. CONCLUSION: The REHAB sexual rehabilitation program after prostatectomy could be implemented with significant patient adherence and satisfaction.

[Endoscopic papillary abnormalities and urinary stone recognition (EPSR): How and why?] / Reconnaissance endoscopique des anomalies papillaires et des calculs urinaires (REPC) : comment et quel intérêt ?

INTRODUCTION: The purpose of this article is to present the endoscopic papillary abnormalities and stone recognition (EPSR) to state-certified nurses (IDE and IBODE) working in the operating room. METHODS: This article is based on a literature review and the author's experience concerning the endoscopic papillary abnormalities and stone recognition. RESULTS: Since the advent of minimally invasive surgery and the laser, stones are no longer sent as one piece to laboratories, but fragmented. This has made it more difficult for biologists to fully analyze the stones, because they have less morphological data than before. Therefore, endoscopic papillary abnormalities and stone recognition have positioned themselves as tools that can compensate for this loss of information. They play a pivotal role in the identification of the lithogenesis cause, and thus allow a recurrence risk reduction of stones. CONCLUSION: Endoscopic papillary abnormalities and stone recognition are recent tools that require learning. However, the benefit of their uses is proven and is necessary for a complete management of urolithiasis.

[Double J stent removal's cost estimate using a re-sterilizable fibroscope in a French private structure]. / Évaluation du coût en structure privée d'une ablation de sonde double J en externe à l'aide d'un fibroscope re-stérilisable.

In front of the arrival of new devices intended to simplify the removal of double J stent, it poses the problem of the knowledge of the real cost of such an ablation under the current conditions of realization. MATERIAL AND METHOD: This is a monocentric economic evaluation of cost and remuneration needed data-gathering of quotation (CCAM, GHS/SE, …), estimate of the associated costs of wear and damping of the endoscopic equipments (endoscopes, cables, …), estimate of the cost of sterilization, estimate of the associated costs to the intervention of staff (Auxiliary nurse [AS] and Nurse [IDE]) with timing of the various tasks. RESULTS: Quotation CCAM JCGE004 (48€) gives access to fixed price SE1 (73.71€ for private clinic, and 75.89€ for public institution) without hospitalization nor anaesthesia. The costs were reported to an act of single double J removal. Concerning the equipments: 4.42€HT for the fibroscopes, graspers, cable and light. The costs of sterilization were: 17.95€HT. The timed workforce's costs were: 7.61-9.51€ for AS and 9.92-10.84€ for IDE. The cost of consumable was about 1.37 €HT, by excluding the common base from the extractions (1.876€HT). The total costs in France in 2016 were thus about 47.4 to 50.496€ including all taxes. CONCLUSIONS: This estimate will be used certainly for reflection on the investments and the future studies of the economic impact of the new devices of extraction, by correlating it of course with the various maintenance contracts from each institution. LEVEL OF PROOF: 4.

[Prostate cancer: Quality assessment of clinical management in the Midi-Pyrenean region in 2011]. / Cancer de la prostate : qualité de la prise en charge en Midi-Pyrénées en 2011.

OBJECTIVES: Assessing the quality of the clinical management of prostate cancer in the Midi-Pyrenean region in 2011. METHODS: The study population was randomly selected among new cases of prostate cancer presented in Multidisciplinary Team Meeting (MTM) in 2011. The indicators defined with the professionals have evaluated the quality of the diagnostic care, when treatment started and at the time of the MTM. RESULTS: Six hundred and thirty-three new patients were included (median age at diagnosis=69years, min: 48; max: 93). In diagnostic period, 92% of patients had a prostate biopsy. Performing a pelvic MRI, an abdomino-pelvic CT and bone scintigraphy concerned respectively 53%, 55% and 61% of intermediate or high-risk patients. The Gleason score, surgical margins and pathological stage were included in over 98% patient records treated by radical prostatectomy. A PSA assay in 3months after prostatectomy was found in 59% of surgical patients. The MTM was performed before treatment to 83% of patients. About three-quarters of surgical patients with stage pT≥3 or pN1 or with no healthy margins were discussed in MTM after surgery. CONCLUSION: Most of the studied indicators reach a high level. However, the lower level of realization of complementary examinations may question about their real place, accessibility and traceability. LEVEL OF EVIDENCE: 4.

Estimation of mating system parameters in an evolving gynodioecous population of cultivated sunflower (Helianthus annuus L.).

Cultivated plants have been molded by human-induced selection, including manipulations of the mating system in the twentieth century. How these manipulations have affected realized parameters of the mating system in freely evolving cultivated populations is of interest for optimizing the management of breeding populations, predicting the fate of escaped populations and providing material for experimental evolution studies. To produce modern varieties of sunflower (Helianthus annuus L.), self-incompatibility has been broken, recurrent generations of selfing have been performed and male sterility has been introduced. Populations deriving from hybrid-F1 varieties are gynodioecious because of the segregation of a nuclear restorer of male fertility. Using both phenotypic and genotypic data at 11 microsatellite loci, we analyzed the consanguinity status of plants of the first three generations of such a population and estimated parameters related to the mating system. We showed that the resource reallocation to seed in male-sterile individuals was not significant, that inbreeding depression on seed production averaged 15-20% and that cultivated sunflower had acquired a mixed-mating system, with ∼50% of selfing among the hermaphrodites. According to theoretical models, the female advantage and the inbreeding depression at the seed production stage were too low to allow the persistence of male sterility. We discuss our methods of parameter estimation and the potential of such study system in evolutionary biology.

[Sacral neuromodulation with InterStim™ system: Results from the French national register]. / Neuromodulation sacrée avec le système InterStim™ : résultats du registre national français.

AIM: To analyse current practice patterns and to evaluate (long-term) effectiveness and adverse events of sacral neuromodulation with InterStim™ Therapy based on data collected in a national register and to discuss the strengths and weaknesses of the register. PATIENTS AND METHODS: This is a French multicenter prospective observational trial including patients with a permanent implant (2003-2009). Voiding diary variables and patient satisfaction were analysed based on last follow-up visit since implantation. RESULTS: One thousand four hundred and eighteen patients (median age: 63 years, 1206 females) were included in the database (median follow-up: 12 months). One thousand and eighty-nine patients had non-neurological disease. The principal diagnosis was overactive bladder syndrome ([OAB], n=1170) and retention (n=151). Implantation occurred in 1358 patients; 1172 patients had greater than or equal to one registered follow-up. Clinical improvement of greater than or equal to 50% was seen in 447/527 patients with OAB at 12 months follow-up (median number of voids per 24 hours decreased from 15 at baseline to 8 at 12 months) and in 42/54 of patients with retention (median number of catheterization per 24 hours dropped from 5 at baseline to 0 at 12 months). Clinical improvement remained relatively stable up to 60 months. Median patient satisfaction with treatment was between 60 and 80%. Five hundred and twenty-four patients had at least one adverse event; loss of efficacy (n=244) occurred most frequently. CONCLUSIONS: In this large database sacral neuromodulation with InterStim™ Therapy seems to be an effective treatment through routine practice in the long-term (up to 60 months) for patients refractory to medical treatment.

[Local staging of prostate carcinoma with phased array MR imaging: prospective study over 5 years]. / Bilan d'extension du cancer prostatique en IRM avec antenne de surface: étude prospective sur 5 ans.

PURPOSE: To assess by MRI, using a pelvic phased array coil, the accuracy for staging prostate carcinoma and to correlate the results with the rate of positive surgical margins. MATERIALS AND METHODS: Between January 1995 and December 1999, 176 patients with localized prostate carcinoma underwent a preoperative MRI examination using a pelvic phased-array coil (1 Tesla). MRI and histological results were compared in a prospective study. RESULTS: 131 were classified T2 and 45 were classified T3 at MRI. Pathologic findings showed 103 pT2 and 73 pT3. The accuracy of MRI (extra capsular or vesicle extension) was 75%. The risk for a patient labelled T2 or T3 at MRI to have a positive surgical margin was respectively 13.7% and 31%. CONCLUSION: This study shows that the phased-array coil has a low sensitivity but a good specificity to distinguish between organ-confined cancer or not. It shows that the risk of positive surgical margins is higher for T3 lesions at MRI. The low sensitivity should be improved by using a multi coil phased array.

Impact of a modified apical dissection during radical retropubic prostatectomy on the occurrence of positive surgical margins: a comparative study in 212 patients.

OBJECTIVES: To assess the impact of a modified technique of apical dissection during radical retropubic prostatectomy on the occurrence of positive surgical margins (PSMs). METHODS: Between 1992 and 1998, 212 nonconsecutive patients with localized prostate cancer (57 T1, 155 T2) underwent radical retropubic prostatectomy and were divided into two groups: group 1, 85 patients who underwent surgery before January 1994; and group 2, 127 patients who underwent surgery with the modification of the apical dissection after January 1994. The modified technique consisted of a wide excision of periprostatic soft tissue at the apex, including the bilateral neurovascular bundles. The clinical data (age, prostate-specific antigen, clinical staging) and pathologic findings (pathologic staging, Gleason score, PSM rate) of the two groups were compared. RESULTS: No significant difference was found between the two groups regarding the median prostate-specific antigen level (10.8 ng/mL and 9.5 ng/mL), Gleason score, and pathologic staging. Overall, the PSM rate was 53% in group 1 and 20.5% in group 2 (P <0.001). The number of PSMs decreased 2.6-fold in group 2. The PSM rate was significantly reduced at the apex with the new technique (group 1, 33.3%; group 2, 7.7%; P = 0.008). The PSM rate expressed with the odds ratio was 4.4-fold lower for patients in group 2 than for those in group 1. CONCLUSIONS: The modified apical dissection in radical retropubic prostatectomy significantly improves the PSM rate in patients with localized T1-T2 prostate cancer.

Assessment of the risk of positive surgical margins with pelvic phased-array magnetic resonance imaging in patients with clinically localized prostate cancer: a prospective study.

OBJECTIVES: We assessed magnetic resonance imaging (MRI) performance in the prediction of positive surgical margins (PSMs) before radical prostatectomy in a prospective study correlating the MRI results and pathologic findings. METHODS: Between January 1995 and December 1999, 176 patients (mean age 64.2 years, range 49 to 75), with localized prostate cancer (49 with Stage T1 and 127 with Stage T2) underwent preoperative MRI with a pelvic phased-array coil (Tesla-1, Siemens) at a mean interval of 35 days after randomized transrectal biopsies. The mean preoperative prostate-specific antigen level was 10.9 ng/mL (range 1.2 to 39). The MRI studies and specimen analysis were performed by one radiologist unaware of the clinical and biopsy findings and by one pathologist, respectively. Multivariate analysis was performed to compare the predictive value of MRI staging, prostate-specific antigen value, and preoperative Gleason score to identify the PSM rate. RESULTS: Of the 176 patients, 131 (74%) had Stage T2 disease by MRI and 45 (26%) Stage T3 disease by MRI. Pathologic staging showed 103 with pT2 and 73 with pT3. Overall, the PSM rate of the series was 18%. The PSM rate was 13.7% and 31% for patients with T2 and T3 disease by MRI, respectively. For the T3 MRI cases, the PSM rate was 2.32-fold higher. MRI staging, like the prostate-specific antigen value, was a predictive factor of PSMs (P = 0.05). CONCLUSIONS: The results of this study show that preoperative MRI staging with the phased-array coil may be helpful in predicting the PSM risk in radical prostatectomy candidates with clinically localized prostate cancer.

Radical cystectomy in patients older than 75 years: assessment of morbidity and mortality.

OBJECTIVE: We have reviewed our surgical experience to assess intra- and postoperative morbidity and mortality in 25 patients 75 years old or older with invasive bladder cancer who underwent radical cystectomy and urinary diversion or bladder substitution. METHODS: Between January 1993 and February 1999, of 190 patients who underwent radical cystectomy, 23 men and 2 women were aged from 75 to 87 (median 79) years. Urinary diversion was performed in 23 cases and bladder substitution in 2. All patients had significant comorbidity and 15 patients were ASA II and 10 ASA III. RESULTS: Median operating time was 4 h. Perioperative mortality rate was 4%. Intraoperative, early and late postoperative complications occurred in 15, 16 and 6 patients, respectively. The most common early complications were pyelonephritis (32%), disorientation (20%), additional pulmonary infection (20%) and prolonged ileus (32%). No secondary procedures were necessary. The most common late complication was ureteroileal anastomotic stricture (16%). The median hospital stay and intensive care unit stay were 24 and 14 days, respectively. With a median follow-up of 14 (5-50) months the overall mortality rate was 32%. CONCLUSIONS: Radical cystectomy can be performed in elderly patients with acceptable perioperative mortality and morbidity. However, because of the high incidence of minor medical complications, hospital stay is often prolonged.

The tension-free transvaginal tape procedure in the treatment of female urinary stress incontinence: a French prospective multicentre study.

OBJECTIVE: To evaluate in a prospective multicentre study (five centres) the preliminary results regarding efficacy and morbidity of the new tension-free transvaginal tape (TVT) technique in the treatment of urinary stress incontinence (USI) in women. METHODS: From November 1996 to May 1999, 52 women of mean age 64 (range 37--91) years underwent the TVT procedure to treat isolated grade 2 or 3 USI (44 cases) or grade 1 or 2 USI associated with uterine or rectal prolapse surgery (8 cases). Twenty-nine patients (55.8%) presented recurrent USI (1--4 previous procedures). Clinical data showed urethrovesical junction hypermobility in 35 cases (67.3%), isolated intrinsic sphincter deficiency (ISD) in 17 cases (32.6%) and pelvic organ prolapse in 8 cases. Urodynamics confirmed ISD in 27 cases (51.9%) with a mean urethral closure pressure of 18.5 (range 7--25) cm H(2)O. All data were collected by surgeons on a questionnaire. RESULTS: The surgical procedure was performed under spinal cord anaesthesia in 82.7% of patients (local anaesthesia 11.5%) with a mean operation time of 30 (range 20--60) min for TVT implantation. Six bladder injuries (11.5%) were identified and the needle was repositioned. Mean hospital stay was 2.5 (range 1-7) days in the group who underwent TVT alone. Mean follow-up of continence was 15.2 (range 6--36) months: 83% of patients were dry and 17% were improved. Nine patients (17.3%) required self-catheterization for 2--10 days postoperatively. No recurrence of USI, defect healing or tape rejection were reported. CONCLUSION: TVT is a new technique for the surgical treatment of USI which is useful for recurrent cases. The advantages are simplicity, low morbidity, reproducibility and reduced operative time. These early results indicate the technique is effective in correcting incontinence and is locally well tolerated. But these are preliminary data and the long-term outcome on USI and the urethra is needed.

Role of preoperative positive apical biopsies in the prediction of specimen-confined prostate cancer after radical retropubic prostatectomy: a multi-institutional study.

OBJECTIVES: A multi-institutional study of 280 radical prostatectomy specimens obtained from three independent academic hospitals was undertaken to validate a nomogram developed for the prediction of specimenconfined protstate cancer after prostatectomy. METHODS: Three preoperative factors - the Gleason score, prostatespecific antigen (PSA) and apical location of positive biopsies - that were identified with a previous logistic regression formula were collected. Links between margin status and preoperative criteria were confirmed by univariate methods. Subsequently, the predictive indexes of positive margins were calculated and compared to the actual margin status in terms of predictive characteristics. RESULTS: This control series, independent of the initial series that was used to identify the relevant preoperative factors, confirmed that positive apical biopsies(p<0.001), PSA (p<0.005) and the Gleason score (p<0.005) were strongly linked to the occurrence of positive margins. Different cutoff values for the predictive index were compared in a receiver operating characteristic curve. A value of 0.5, similar to the one described in the original series, gave an adequate compromise between sensitivity and specificity with respective values of 68 and 73% and a test accuracy of 72%. In practical terms, it was possible to predict 85% of negative margins, and to delineate two groups with different rates of positive margins (14.5 vs. 50%). CONCLUSIONS: We demonstrated that PSA, the Gleason score and apical biopsy status are cumulative risk factors for positive margins. Risk of positive margins increases when it is not possible to obtain a wide excision of periprostatic fascia, as at the apex. This study substantiates the independent prognostic value of positive preoperative apical biopsies for predicting positive surgical margins.

[Renal adenocarcinoma with retrohepatic vena cava thrombus: role of extracorporeal circulation in a retrospective series of 10 cases]. / L'adénocarcinome rénal avec thrombus cave rétro-hépatique: place de la circulation extra-corporelle sur une série rétrospective de 10 cas.

INTRODUCTION: Renal cell carcinoma is accompanied by tumour thrombus in the inferior vena cava (IVC) in 4 to 10% of cases. Since the use of cardiopulmonary bypass (CPB), surgery for extensive thrombus has been improved by reduction of blood loss, facilitating complete resection of the kidney and thrombus and possible repair of the inferior vena cava. OBJECTIVES: To analyse a retrospective series of 10 cases and to compare the complications of CPB and conventional surgery by direct clamping. MATERIAL AND METHODS: From February 1985 to December 1997, 413 patients were operated for renal cancer, including 23 (5.6%) patients with tumour thrombus in the inferior vena cava. Ten of these 23 cases of inferior vena caval thrombus were retrohepatic. Group I (5 patients) was operated under CPB and profound hypothermia at 16 degrees C (mean duration of bypass: 30 min). Group II (5 patients) was operated by conventional surgery (CS) (mean clamp time: 12 min). RESULTS: No difference in terms of intraoperative complications was observed between the two groups, but 2 deaths occurred in group II due to respiratory decompensation, 1 and 2 weeks postoperatively. CONCLUSION: The level of the thrombus in the inferior vena cava determines the mode of vascular management. The presence of invasion of the inferior vena cava wall is difficult to predict because of the poor sensitivity of radiological examinations. CPB did not induce any excess morbidity in this series. The use of CPB in renal cancers with retrohepatic thrombus facilitates the resection procedure and allows inferior vena cava reconstruction in a bloodless environment.

[Large-cell calcifying Sertoli cell tumors: apropos of a case and review of the literature]. / Les tumeurs calcifiées à grandes cellules de Sertoli: à propos d'un cas et revue de la littérature.

The authors report the case of a 22-year-old man presenting with a tumour of the lower pole of the left testis, present for 4 months, which proved to be a calcified Sertoli large cell tumour, an extremely rare group of sex cord tumours of the testis presenting specific clinical and histological features. These tumours are usually benign, occur during the first two decades of life and can be associated with dysplastic complexes or endocrinopathies (Carney's complex, Peutz-Jeghers syndrome). They present either in the form of bilateral, multifocal tumours in the context of a pathological association, or in the unilateral form, without association. Several malignant forms with metastases have been described. Conventional treatment is transinguinal radical orchidectomy.

[Ureteral and vesicular endometriosis: case report]. / Endométriose urétérale et vésicale: à propos d'une observation.

The authors report a case of both vesical and ureteral endometriosis diagnosed after recurrent acute pyelonephitis. A Gonadotrophin-Releasing Hormone (GnRH) agonist therapy and a conservative endoscopic management is started allowing an almost complete regression of the lesions. A review of the literature is presented about this unexceptional localisation of endometriosis (1 to 2% of all endometriosis).

[Value of free PSA/total PSA ratio in therapeutic decisions in the case of a single positive biopsy of the prostate]. / Intérêt dans la décision thérapeutique du rapport PSA libre/PSA total en cas de biopsie de prostate unipositive.

OBJECTIVES: Study of the value of the free PSA/total PSA ratio in the therapeutic decision concerning prostatic adenocarcinoma, in the case of a single positive biopsy. MATERIAL AND METHODS: The free PSA/total PAS ratio was calculated on serum samples derived from 37 patients with clinically localized prostatic carcinoma and only one positive biopsy, in whom radical prostatectomy was performed. RESULTS: The free PSA/total PSA ratio appeared to be independent of pathological stage and histological prognostic criteria (grade and score, degree of capsular effraction). CONCLUSION: In the case of a single positive biopsy, calculation of the free PSA/total PSA ratio does not appear to provide any decisional criteria in favour of radical prostatectomy.

[The use of MRI with a pelvic phased array antenna in the evaluation of the gland and tumor volume of clinically localized prostatic adenocarcinoma]. / Utilisation de l'IRM avec antenne "phased array" pelvienne dans l'évaluation des volumes glandulaires et tumoraux de l'adénocarcinome prostatique cliniquement localisé.

UNLABELLED: Prostate cancer is clinically understaged in 50% of cases. It was improved with the use of random biopsies, PSA analysis (balanced and unbalanced) and Gleason grade on biopsies. Traditional imaging techniques such as endorectal ultrasonography and CT Scan are known to be of no interest. MRI is a non-evasive technique which allows the three dimensional study of an organ with a high quality of tissue contrast. Moreover, the positioning of surface antennae or "phased array" allowed improvement in spatial resolution. OBJECTIVE: To determine whether MRI allows an accurate staging of clinically localised adenocarcinoma by the direct estimation of capsular effraction, measure of glandular and tumor volumes and finally by obtaining reliable PSAd. MATERIAL AND METHODS: A prospective study was done from March 1995 to November 1996 on 55 patients with a clinically localised adenocarcinoma. MRI 1 Tesla Imager (SIEMENS), pelvic phased array antennae. FSE sequences (T1 and T2), axial and frontal. Evaluation of volumes by on-screen. Standford protocol for histo-pathologic reading on the axial cuts. Direct planimetry on a millimetre paper. RESULTS: Reliable estimation of glandular volume (average difference 0.7 cc). Sub-evaluation of tumoral volume (average difference 1.04 cc) with a 30% margin of error, accuracy 87%. Tumoral stage exact in almost 90% of the cases with a PPV of 94%. CONCLUSION: Prostatic MRI, using surface antennae, allows to complete the conventional stage by stage development by correctly diagnosing 75% of locally evolved stages. Its limits are linked to the nature of the signal of the tumorous tissue as to the localisation of neoplasic lesions.

[Prevention of sterility in spinal cord injured men]. / Prévention de la stérilité chez le traumatisé médullaire.

The reproductive function of spinal cord injured males is not the primary concern of health professionals responsible for the management of these young adults. However, the fertility of these patients is threatened right from the first days after trauma, as indicated by abnormalities of the sperm count, reflecting the histological alterations observed on testicular biopsy. The factors predisposing to asthenoteratospermia, responsible for impaired fertility, are analysed and discussed. Urinary tract infection is the leading factor. This acute situation must be managed early, by preventing urinary tract infection and by obtaining a semen donation as soon as possible, after improvement of the general status.

[Ureteral involvement in an inflammatory aneurysm of the abdominal aorta. (Apropos of a case. Review of the literature)]. / L'atteinte urétérale dans les anévrysmes inflammatoires de l'aorte abdominale (A propos d'un cas. Revue de la littérature).

Diagnosis and treatment of ureteral obstruction secondary to perianeurysmal retroperitoneal fibrosis are controversial. Diagnosis includes the use of computed tomography and abdominal ultrasound, surgical treatment combines prosthetic graft with preoperative ureteral stenting. Ureterolysis is not always necessary, because aneurysm repair promotes resolution of the inflammatory process and relieves the ureteric obstruction. However radiologic survey is essential as in the case report.

[Carcinoma in situ on ureteric stump after cystectomy treated by BCG]. / Carcinome in situ sur uretére restant aprés cystectomie traité par BCG.

Intravesical BCG is the reference adjuvant therapy for superficial urothelial tumours. Its adverse effects and the modalities of follow-up are now clearly established. We treated a female patient by antegrade BCG instillation for a carcinoma in situ discovered in a ureteric stump following cystectomy for generalised CIS. Treatment was well tolerated and no recurrence was observed with a follow-up of 3 years.