Biomedical subjects

Andrea Gallina

Publications and source records attributed to Andrea Gallina.

At least 19 recordsLinked to original sources

PubMed2007

Tumour volume and high grade tumour volume are the best predictors of pathologic stage and biochemical recurrence after radical prostatectomy.

INTRODUCTION: Our goal was to examine to what extent tumour volume (TV) and percentage of high grade tumour volume (%HGTV) affect the rate of positive surgical margins and the rate of biochemical recurrence after radical prostatectomy. MATERIALS AND METHODS: TV and %HGTV were routinely planimetrically quantified in a cohort of 780 consecutive patients. Mean follow-up was 46.7 months. Multivariable regression models addressed two separate endpoints: positive surgical margins and biochemical recurrence. The increase in model predictive accuracy related to the addition of TV and %HGTV to radical prostatectomy stage and grade was assessed, after 200 bootstrap resamples to reduce overfit bias. RESULTS: In multivariable logistic regression models addressing positive surgical margins rate, predictive accuracy increased by 1.9% (p<0.001) when TV was added to other covariates. No further increment was noted when %HGTV was added (p=0.3). In multivariable Cox regression models addressing biochemical recurrence, accuracy increased by 0.6% (p=0.002) when TV was added and an additional increase of 0.7% was recorded when %HGTV (p<0.001) was added. CONCLUSION: Tumour bulk reflected by TV affects local cancer control rate, which is reflected in the rate of positive surgical margins. Conversely, high grade cancer determines the rate of biochemical recurrence. These two variables represent the most powerful predictors of cancer control in men treated for localised prostate cancer. Moreover, they increase the ability of established predictors to predict the outcomes of interest. In consequence, they warrant consideration in future predictive and prognostic tools.

Adult↗

PubMed2006

Prediction of pathological stage is inaccurate in men with PSA values above 20 ng/mL.

INTRODUCTION: We hypothesized that either very low (0-2.5 ng/mL) or very high (>20 ng/mL) PSA values may limit the accuracy of pathological stage predictions. To test this hypothesis, we examined 5193 consecutive patients subjected to radical prostatectomy (RP) for localized prostate cancer (PCa). MATERIAL AND METHODS: Patients were divided into three cohorts according to their pre-treatment PSA value: </=2.5 (n=331), 2.51-20 (n=4545) and >20 ng/mL (n=317). Subsequently in each cohort, the ability of PSA, clinical stage and biopsy Gleason sum was tested in multivariable logistic regression models predicting three separate endpoints: extracapsular extension (ECE), seminal vesicle invasion (SVI) and lymph node invasion (LNI). Predictive accuracy represented the performance benchmark. All models were adjusted for year of surgery and subjected to 200 bootstrap resamples to reduce overfit bias. RESULTS: For PSA </=2.5 ng/mL, predictive accuracy was 76.7%, 72.3% and 82.8% for respectively ECE, SVI and LNI. For PSA 2.51-20 ng/mL, the predictive accuracy for the same endpoints was 67.8%, 77.4% and 81.6%. Finally, for PSA >20 ng/mL, predictive accuracy was 63.6%, 63.7% and 70.6%. CONCLUSIONS: The ability to predict pathological stage in patients with PSA values in excess of 20 ng/mL significantly decreased, compared to patients with lower PSA values. Therefore, accurate staging of these patients may require alternative markers or staging schemes.

Adult↗

PubMed2006

Prostate cancer-specific survival in men treated with hormonal therapy after failure of radical prostatectomy.

OBJECTIVES: We hypothesized that prostate cancer-specific survival (PCaSS) could be accurately predicted in men in whom radical prostatectomy (RP) failed and who received hormonal therapy (HT) after RP failure. METHODS: Between 1954 and 1994, 752 consecutive patients underwent RP without neoadjuvant therapy. Of those, 114 patients (15.2%) received HT at RP failure and represent the focus of this analysis. Cox regression models and a nomogram targeted PCaSS. The main predictor was timing of HT initiation: at prostate-specific antigen (PSA) versus local versus distant recurrence. Covariates included age at HT, pathologic T stage, surgical margin status and Gleason sum at RP, use of adjuvant or salvage radiation, and time from RP to HT. RESULTS: Mean and median follow-up periods were 5.1 and 3.9 yr; 70 deaths were recorded, of which 45 (39.8%) were due to PCa. At 1, 5, 10, and 15 yr, the estimates of PCaSS were, respectively, 97.1%, 68.3%, 49.3%, and 30.2% (median, 9.8 yr). Younger men and those with HT initiated at the time of distant recurrence had lower PCaSS. A nomogram predicting PCaSS at 2, 3, 4, and 5 yr after RP was developed and demonstrated 66% accuracy after 200-bootstrap internal validation. CONCLUSION: Despite RP failure, half the patients can expect to survive for 10 yr. The nomogram can help in discriminating between those with better versus worse PCaSS, better than relying on most educated guesses.

Aged↗

PubMed2006

Sunitinib relieves renal cell carcinoma spinal cord compression.

A 66-year-old previously healthy female was diagnosed with renal cell carcinoma (RCC) metastic to the 4th, 6th and 12th thoracic vertebrae. Despite external beam radiotheraphy (20G in 5 fractions), she progressed to spinal cord compression within 4 weeks and was wheelchair bound. Radiation and surgery were not considered suitable, but sunitinib was initiated. After two 6-week sunitinib cycles, she is fully ambulatory. She reports grade I fatigue and occasional epistaxis, as sole side effects. This case demonstrates that despite the rapid progression of the disease, which escaped the effect of radiation within four weeks, sunitinib resulted in complete clinical symptom resolution, which was confirmed radiographically. Moreover, it appears that the novel therapies for metastatic RCC may restore quality and quantity of life to many of those, whose disease previously appeared too advanced to treat.

Aged↗

PubMed2006

Surgical volume is related to the rate of positive surgical margins at radical prostatectomy in European patients.

OBJECTIVE: To assess the association between surgical volume (SV) and the rate of positive surgical margins (PSM) after radical prostatectomy (RP) in a large single-institution European cohort of patients. PATIENTS AND METHODS: In all, 2402 men had a RP by a group of 11 surgeons, all of whom were trained by the surgeon with the highest SV; all surgeons used the same surgical technique. Variables assessed before RP were prostate-specific antigen (PSA) level, clinical stage and biopsy Gleason sum; variables assessed after RP were PSA level, extracapsular extension, seminal vesicle invasion, lymph node invasion and pathological Gleason sum. These were used to predict the rate of PSM in models before or after RP. Multivariate models were complemented with SV to test its independent and multivariate statistical significance and to quantify its impact on the model's overall (and 200 bootstrap-corrected) predictive accuracy. RESULTS: The mean (range) SV was 201 (1-1293) RPs; the mean (median, range) rate of PSM was 20.2 (21.4, 0-32.9)%. In multivariate models, SV was a highly statistically significant independent predictor of PSM (P < 0.001) and increased the predictive accuracy in multivariate models both before (2.0%) and after RP (1.5%, both P < 0.001). However, when the surgeon with the highest SV, who contributed to 1293 cases, was removed from the analyses, the multivariate independent prediction and the gains in predictive accuracy related to adding SV, disappeared in the models both before (P = 0.9, accuracy gain 0.1%) and after (P = 0.4, accuracy gain - 0.3%) RP. CONCLUSIONS: These results indicate that patients treated by surgeons with a very high volume can expect to have a significantly lower rate of PSM, after accounting for clinical and pathological case-mix differences. However, SV is not a predictor of PSM when analyses are restricted to intermediate- and low-volume surgeons.

Clinical Competence↗

PubMed2006

Development and external validation of an extended 10-core biopsy nomogram.

OBJECTIVES: To test the accuracy of a previously externally validated sextant biopsy nomogram in referred men exposed to > or =10 or more biopsy cores. Moreover, we explored the hypothesis that a more accurate predictive tool could be developed. METHODS: Previous nomogram predictors (age, digital rectal examination, prostate-specific antigen, and percent free PSA) were used to assess the accuracy of our previous nomogram in a cohort consisting of 2900 men referred for prostatic evaluation. Moreover, these variables were complemented with sampling density (SD) (i.e., ratio of gland volume and the number of planned biopsy cores) within multivariable logistic regression models (LRM) predicting presence of prostate cancer (pCA) on the initial 10 or more core biopsy. The LRMs were used to develop and internally validate (200 bootstrap resamples) a new nomogram in 1162 men from Hamburg, Germany. The LRMs' external validity was tested in three separate cohorts (Hamburg, n=582; Milan, n=961; Seattle, n=195). RESULTS: The contemporary external validation of the previously validated sextant nomogram demonstrated 70% accuracy. Internal validation of the new nomogram demonstrated 77% accuracy, and external cohorts demonstrated 73-76% accuracy. CONCLUSIONS: In the era of extended biopsy schemes, previously developed predictive models are less accurate in predicting the probability of pCA on initial biopsy. We developed a new tool that allows obtaining more accurate predictions. Moreover, before biopsy, it also allows defining the ideal ratio between gland volume and the number of planned biopsy cores that would yield the ideal biopsy rate.

Adult↗

PubMed2006

Complications and other surgical outcomes associated with extended pelvic lymphadenectomy in men with localized prostate cancer.

OBJECTIVES: More-extensive pelvic lymph node dissection (PLND) may be associated with a higher rate of complications and a longer hospital stay than more limited PLND. METHODS: Before radical retropubic prostatectomy, PLNDs were performed in 963 patients. Of these, 767 (79.6%) had >or=10 lymph nodes removed and examined (extended PLND [ePLND]), while 1-9 nodes (limited PLND [lPLND]) were removed in the remaining 196 (20.4%). Limits included external iliac, obturator, internal iliac, and iliac bifurcation. PLND-related complications and the length of hospital stay were recorded prospectively and analyzed according to the extent of PLND. RESULTS: In patients subjected to ePLND, the overall rate of complications was 19.8% versus 8.2% in those treated with lPLND (p<0.001). In individual analyses of specific complications, only the lymphocele rate was significantly higher after ePLND (10.3% vs 4.6%; p=0.01). Similarly, ePLND translated into a longer hospital stay (9.9 vs 8.2 d; p<0.001). These differences persisted when adjustment was made for prostate-specific antigen and either clinical or pathologic tumor characteristics. CONCLUSIONS: Our data indicate that, even in the hands of experienced urologic surgeons, ePLNDs are associated with higher complication rates and longer hospital stay. These detriments need to be taken into account when the staging benefit associated with ePLND is considered.

Adult↗

PubMed2006

Prostate cancer nomograms: an update.

OBJECTIVE: Several nomograms have been developed to predict outcomes related to prostate cancer (PCa). METHODS: We provide a descriptive and an analytic comparison of nomograms. Further, we report a set of recent PCa nomograms, in which we recorded predictor variables, number of patients used to develop each nomogram, and nomogram-specific features. Moreover, accuracy estimates and type of validation are considered. RESULTS: Our findings suggest a demand for updated nomograms in selected fields of PCa outcomes. Moreover, an increasing number of nomograms address important end points such as prostate-specific antigen recurrence, distant metastases, or androgen-independent PCa-specific survival. CONCLUSION: Our results suggest that nomograms are available for many PCa-related outcomes. They represent a valid methodologic approach if correct criteria are met.

Biopsy↗

PubMed2006

Initial biopsy outcome prediction--head-to-head comparison of a logistic regression-based nomogram versus artificial neural network.

OBJECTIVES: Nomograms and artificial neural networks (ANNs) represent alternative methodologic approaches to predict the probability of prostate cancer on initial biopsy. We hypothesized that, in a head-to-head comparison, one of the approaches might demonstrate better accuracy and performance characteristics than the other. METHODS: A previously published nomogram, which relies on age, digital rectal examination, serum prostate-specific antigen (PSA), and percent-free PSA, and an ANN, which relies on the same predictors plus prostate volume, were applied to a cohort of 3980 men, who were subjected to multicore systematic prostate biopsy. The accuracy and the performance characteristics were compared between these two approaches. RESULTS: The accuracy of the nomogram was 71% versus 67% for the ANN (p=0.0001). Graphical exploration of the performance characteristics demonstrated virtually perfect predictions for the nomogram. Conversely, the ANN underestimated the observed rate of prostate cancer. CONCLUSIONS: A 4% increase in predictive accuracy implies that the use of the nomogram instead of the ANN will result in 40 additional patients who will be correctly classified between benign and cancer.

Adult↗

PubMed2006

Zonal origin of localized prostate cancer does not affect the rate of biochemical recurrence after radical prostatectomy.

OBJECTIVE: To investigate whether transition zone (TZ) prostate cancers demonstrate different rates of biochemical recurrence after radical prostatectomy compared to peripheral zone (PZ) cancers. METHODS: In 1262 consecutive patients treated with radical prostatectomy, computerized planimetry defined tumour origin as either TZ tumours (>70% TZ location) or PZ. Kaplan-Meier and multivariate Cox regression models tested the association between zonal origin and the rate of biochemical recurrence (prostate-specific antigen >0.1ng/ml and rising). We used the Harrell's concordance index to quantify the accuracy of various Cox regression models. RESULTS: TZ prostate cancers were diagnosed in 115 patients (9.1%). Biochemical recurrence was recorded in 16 TZ and in 201 PZ prostate cancers patients. In multivariate Cox models, the rate of biochemical recurrence was not significantly different between TZ and PZ prostate cancers (p=0.4). Combined multivariate predictive accuracy of biochemical recurrence predictions was 81.2% accurate when zonal origin was included versus 81.0% when zonal origin was omitted. CONCLUSIONS: The zonal origin of prostate cancers does not affect the rate of biochemical recurrence after radical prostatectomy.

Humans↗

PubMed2006

Validation of a nomogram predicting the probability of lymph node invasion based on the extent of pelvic lymphadenectomy in patients with clinically localized prostate cancer.

OBJECTIVE: To develop a multivariate nomogram to predict the rate of lymph node invasion (LNI) in patients with clinically localized prostate cancer according to the extent of extended pelvic lymphadenectomy (PLND), which is associated with significantly higher rate of LNI. PATIENTS AND METHODS: The study comprised 781 consecutive patients (median age 66.6 years, range 45-85) treated with PLND and radical retropubic prostatectomy (RRP) for clinically localized prostate cancer. Their median (range) prostate-specific antigen (PSA) level was 7 (1.03-49.91) ng/mL, and their clinical stages were T1c in 433 (55.4%), T2 in 328 (42%) and T3 in 20 (2.6%). Biopsy Gleason sums were <or= 6 in 514 (65.8%), 7 in 204 (26.1%) and 8-10 in 63 (8.1%). Multivariate logistic regression models were used to test the association between predictors including PSA level, biopsy Gleason sum, clinical stage, number of nodes removed and the rate of LNI. Finally, regression coefficients were used to develop a nomogram, which was internally validated with 200 bootstrap re-samples. RESULTS: The median (range) number of lymph nodes removed was 14 (2-40); LNI was detected in 71 patients (9.1%). The univariate predictive accuracy for total PSA level, clinical stage, biopsy Gleason sum and number of total nodes removed and examined was 64.2%, 59.8%, 74% and 62.9%, respectively. Except for PSA (P = 0.2), all variables were statistically significant multivariate predictors of LNI at RRP (P <or= 0.001). A nomogram based on clinical stage, PSA level, biopsy Gleason sum and the number of total lymph nodes removed was 78.6% accurate, and 1.8% more accurate than a nomogram without the number of removed lymph nodes. CONCLUSIONS: The extent of PLND is directly related to the probability of LNI. The risk of LNI increases linearly, and is proportional to the number of nodes removed and examined. The effect of the increased probability of LNI is weighted more heavily in men with more advanced clinical stage and grade.

Aged↗

PubMed2006

A nomogram for staging of exclusive nonobturator lymph node metastases in men with localized prostate cancer.

OBJECTIVES: Some patients with localized prostate cancer are at risk of nonobturator lymph node invasion (NOLNI) and may require an extended pelvic lymph node dissection (ePLND). We explored the rate of exclusive NOLNI and developed a nomogram to predict it. MATERIAL AND METHODS: We mapped all ePLND specimens according to their anatomic location (obturator, external iliac, internal iliac lymph nodes) and assessed the location-specific rate of LNI in 565 patients. A multivariate logistic regression-based nomogram predicting NOLNI was then internally validated with 200 bootstrap resamples. RESULTS: Overall, 11.1% (63 of 565) had LNI and 21 (3.7%) had exclusive NOLNI. The nomogram predicting exclusive NOLNI was 80.2% accurate. The nomogram's negative predictive value was 99%, when it predicted 0-10% probability of NOLNI. This approach could allow the omission of an ePLND in 350 of 565 (61.9%) patients and still correctly stage 85.8% of NOLNI cases. CONCLUSIONS: Our nomogram-based approach offers the possibility of identifying men who are at virtually zero risk of exclusive NOLNI. In these men, an ePLND may be safely avoided.

Adult↗

PubMed2006

Baseline potency in candidates for bilateral nerve-sparing radical retropubic prostatectomy.

OBJECTIVES: To assess the baseline erectile function (EF) of patients with clinically localized prostate cancer (pCa), who are candidates for a bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP) to (a) objectively rate the preoperative self-reported subjective patient's EF and (b) investigate possible correlations between preoperative EF and demographic data and comorbidities. MATERIALS AND METHODS: Two-hundred-thirty-four patients, who verbally self-reported they were preoperatively fully potent and strongly motivated to maintain postoperative EF, underwent a BNSRRP. A comprehensive medical and sexual history was obtained on hospital admission the day prior to surgery. Subjectively reported potency rate was compared with the scores of the International Index of Erectile Function (IIEF). RESULTS: The EF domain of the IIEF showed a baseline normal EF in only 43% of the subjects. In contrast, 13% had a mild erectile dysfunction (ED), 8% had a mild to moderate ED, 8% complained of a moderate ED, and as many as 28% reported severe EF impairment. Interestingly, 38% of the patients with severe ED did not attempt any intercourse during the last 4 weeks prior to surgery. CONCLUSIONS: A significant proportion of patients with clinically localized pCa and self-reported total potency already had suffered from ED preoperatively. Incorrect timing of questionnaires administration, the potential influence of preoperative patient's psychological distress, and the implication of the patient's partner's psychological and sexual health may be contributing factors to the contradictory finding. The preoperative use of validated questionnaire may help to identify patients who can actually expect to regain potency following a BNSRRP.

Adult↗

PubMed2006

Holmium laser enucleation versus open prostatectomy for benign prostatic hyperplasia: an inpatient cost analysis.

OBJECTIVES: To compare the cost of open transvesical prostatectomy (OP) with that of holmium laser enucleation (HoLEP) in the treatment of bladder outlet obstruction (BOO) attributed to benign prostatic hyperplasia. METHODS: From February to May 2004, 63 consecutive patients with symptomatic benign prostatic hyperplasia in a large prostate (70 to 220 g) and documented BOO were randomized to surgical treatment with OP (29 in group 1) or HoLEP (34 in group 2). All costs associated with the procedures during the hospital stay were recorded prospectively, and a cost-effectiveness analysis of the critical perioperative (ie, intraoperative and postoperative to hospital discharge) data was performed. RESULTS: The cost analysis showed a mean perioperative cost of 2868.9 euros (3556.3 dollars) for group 1 and 2356.5 euros (2919.4 dollars) for group 2. A direct comparison analysis showed that the most significant cost factors were the operative time (average 16.1% and 25.1% to the cost of OP and HoLEP, respectively), operating room surgical setup/disposables, including laser fiber and resectoscope loop in group 2 (average 13.3% and 29.3% to the cost of OP and HoLEP, respectively), and length of postoperative hospital stay (average 53.3% and 32.0% to the cost of OP and HoLEP, respectively). Overall, the hospitalization cost of HoLEP was 9.6% less than that for OP. CONCLUSIONS: Our data have demonstrated that HoLEP is associated with a significant hospital net cost savings compared with OP in patients undergoing surgery for symptomatic benign prostatic hyperplasia in large glands.

Aged↗

PubMed2006

Bone metastases are infrequent in patients with newly diagnosed prostate cancer: analysis of their clinical and pathologic features.

OBJECTIVES: To investigate the clinical and pathologic characteristics of patients with bone metastases identified at the time of newly diagnosed prostate carcinoma at biopsy. METHODS: From November 2002 to May 2004, 1587 consecutive patients had a pathologic diagnosis of prostate cancer and underwent conventional technetium-99m methylene diphosphonate scintigraphy of the entire body. The clinical and pathologic features of those patients with positive bone scan findings (group 1) were compared with those of a subcohort of 372 patients with negative bone scan findings performed at the same nuclear medicine department (group 2). RESULTS: A retrospective complete data collection was available for 1242 of 1587 patients. Bone metastases were found in 31 patients (2.5%). As expected, patients with skeletal metastases had a significantly greater mean serum total prostate-specific antigen level, and a Gleason sum of 8 or 9 was significantly more frequent in the pathologic findings of these subjects. Group 1 patients had a significantly greater prevalence of previous nonprostate primary neoplasms (chi-square 12.74, df = 1, P = 0.0004) and reported a greater prevalence of current use of H2 blockers for the treatment and prevention of gastroesophageal reflux disorders (chi-square 37.52, df = 1, P < 0.0001) than did group 2 patients. CONCLUSIONS: Our data have confirmed that bone metastases are more frequent in patients with high prostate-specific antigen levels and poorly differentiated tumors at biopsy regardless of the patient's age. A history of previous nonprostate primary neoplasms and the use of H2 blockers seemed to be more prevalent in those patients with bone metastases at diagnosis.

Aged↗

PubMed2006

Impact on sexual function of holmium laser enucleation versus transurethral resection of the prostate: results of a prospective, 2-center, randomized trial.

PURPOSE: We compared the impact of HoLEP and TURP on sexual function. MATERIALS AND METHODS: Between January 2002 and January 2003, 120 patients with a mean age +/- SD of 65.2 +/- 7.1 years who had benign prostatic hyperplasia were enrolled in this 2-center, prospective, randomized study. A total of 60 patients with a mean age of 65.25 +/- 6.9 years underwent HoLEP (group 1) and 60 with a mean age of 64.18 +/- 7.2 years underwent TURP (group 2). Patients were assessed before surgery, and at 12 and 24-month followup visits. Subjective symptoms were scored by the International Prostate Symptom Score, the International Prostate Symptom Score quality of life question, IIEF, 10 nonvalidated general assessment questions, physical examination, serum prostate specific antigen and transrectal ultrasonography. RESULTS: A total of 32 patients (53.3%) in group 1 and 31 (51.6%) in group 2 reported various degrees of erectile dysfunction before surgery according to the IIEF-EF score. Differences between preoperative and postoperative orgasmic domain scores in each group were significant (p <0.001). A slight but not significant increase in the mean IIEF-EF domain score was reported in each group at postoperative assessments without any difference between the 2 surgical approaches. According to general assessment question analysis the prevalence of subjectively reported postoperative retrograde ejaculation was significantly higher than at baseline assessment in the 2 groups with no differences between the 2 surgical procedures. CONCLUSIONS: TURP and HoLEP significantly lowered the IIEF orgasmic function domain with no differences between techniques. This was caused by retrograde ejaculation. Marginal, nonsignificant erectile function improvement was reported after surgery in the 2 groups.

Aged↗

PubMed2005

Improving the preservation of the urethral sphincter and neurovascular bundles during open radical retropubic prostatectomy.

OBJECTIVES: To describe a technique for open nerve-sparing radical retropubic prostatectomy. METHODS: The technique basically implies incising the levator and prostatic fasciae high anteriorly (1 and 11 o'clock positions) over the prostate, developing the plane between the prostatic capsule and prostatic fascia, and displacing the neurovascular network localized between the two fasciae laterally. This allows for a minimal-touch dissection of the external urethral sphincter and a very efficient dissection of the neurovascular bundles at the level of membranous urethra and prostatic apex. RESULTS: Forty-two patients underwent a bilateral nerve-sparing operation and were followed- up for 6 months. Six patients (14.3%) had positive margins: 4 patients had pT2 disease (in all, the positive margin was monofocal) and 2 patients had pT3 disease (both had multifocal positive margins). Continence (defined as being dry or having one pad remain dry for 24 hours) was achieved in 44% of patients at catheter removal, and in 60%, 72%, and 90% of patients at the 1-, 3-, and 6-month follow-up visits. Potency (defined as an erectile function domain score > or =26) was obtained in 15%, 40%, and 52% of patients at the 1-, 3-, and 6-month follow-up visits. All patients used a PDE5-inhibitor during the investigation period. CONCLUSIONS: These preliminary results suggest that the high incision of the levator and prostatic fasciae may facilitate efficient preservation of the external urethral sphincter and the neurovascular bundles innervating the corpora cavernosa and the sphincter.

Aged↗

PubMed2005

Pfannenstiel versus vertical laparotomy in patients undergoing radical retropubic prostatectomy with spinal anesthesia: results of a prospective, randomized trial.

OBJECTIVE: To evaluate the impact of a standard vertical laparotomy versus a Pfannenstiel transverse laparotomy on intra-, peri-operative, and 6-month follow-up outcome in patients undergoing radical retropubic prostatectomy with pelvic lymphadenectomy with spinal anesthesia. METHODS: Between January 2003 and June 2003, 69 age-matched consecutive patients with clinically localized prostate cancer underwent radical retropubic prostatectomy with pelvic lymphadenectomy with spinal anesthesia and were randomized into Group 1 (vertical laparotomy: 35 patients) and Group 2 (Pfannenstiel laparotomy: 34 patients). An extensive analysis of the critical intra-, peri-operative, and 6-month follow-up clinical parameters was performed. RESULTS: Both the hemodynamics and the biochemical balance were not significantly different between the two groups. Overall blood loss (p = 0.78), autologous (p = 0.88) and homologous (p = 0.36) blood transfusions were similar regardless of the type of laparotomy. Surgical time was not significantly (p = 0.27) different between the two groups. Similarly, the two forms of laparotomy did not differ regarding the length of the surgical incision (p = 0.21), as measured at the end of the procedure. Post-operative oxygen saturation percentage by pulse oximetry, as well as post-op sedation score, were not significantly different (p = 0.06 and p = 0.97, respectively). Waiting time in the post-operative holding area (p = 0.15), and pain score in the post-operative holding area (p = 0.9) as well as on post-operative day 1 (p = 0.1) were not significantly different between the two groups. The rate of first flatus passage and of unassisted ambulation were similar regardless of the type of laparotomy during post-operative day day 1. The two types of incision made it possible to remove a similar (p = 0.34) number of pelvic lymph nodes and were associated to a similar rate of positive surgical margins among pT2 patients. At the 6-month follow-up the occurrence of a pelvic lymphocele and of deep venous thrombosis was similar in the two groups (p = 0.6 and p = 0.16, respectively). Complete urinary continence and spontaneous erectile function recovery was reported in a similar number of patients regardless of the type of surgical incision (p = 0.59 and p = 0.40, respectively). CONCLUSIONS: These results suggest that a Pfannenstiel transverse suprapubic laparotomy does not result in a significantly different outcome from a standard vertical laparotomy in patients undergoing a radical retropubic prostatectomy with pelvic lymphadenectomy with L2-L3 spinal anesthesia for clinically localized prostate cancer.

Aged↗