How to Manage Endometriosis in Adolescence: The Endometriosis Treatment Italian Club Approach.

The evaluation of endometriosis in an adolescent girl is a challenging topic. The initial stage of the disease and the limited diagnostic instrument appropriate for the youth age and for its typical features can reduce the ability of the gynecologist. At the same time, missing a prompt diagnosis can delay the beginning of specific and punctual management of endometriosis, which could avoid a postponed diagnosis from 6 to 12 years, typical of adolescent girls complaining of dysmenorrhea. This article aimed to answer all the potential questions around the diagnosis and management of endometriosis in adolescents starting from a clinical case looking at the possible solution that is easily reproducible in the clinical practice.

Sequential combined approach in patients with mixed urinary incontinence: surgery followed by posterior tibial nerve stimulation.

AIM: The aim of the study is to demonstrate the efficacy of sequential combined treatment with Transobturator Tape (TOT) followed by Posterior Tibial Nerve Stimulation (PTNS) in patients with Mixed Urinary Incontinence (MUI); quality of life and patients' satisfaction was also assessed. METHODS: Retrospective analysis on women affected by MUI with prevalent Stress Urinary Incontinence (SUI) component. Women, divided in 2 groups, underwent different treatments, TOT vs TOT+PTNS. Population was assessed by medical history, previous pelvic surgery, clinical exam, urodynamic exams, pelvic ultrasound examination, and questionnaires (The International Consultation on Incontinence Questionnaire Short Form, Overactive Bladder Questionnaire, Health Related Quality of Life) comparing them before and after 12 weeks after treatment. RESULTS: 112 women were enrolled in the study. The mean age was 57.96±7.34 in the first group(N=60) and 58.29±6.14 in the second group(N=52). Peak flow (ml/s) statistically improved after treatment, 22.23±4.29 (TOT) vs 24.81±5.8 (TOT+PTNS). First voiding desire(ml) improved significantly between the two groups 108.72±19.24 vs 142.43±19.98. Maximum cystometric capacity (ml) in the TOT group at 12-weeks was 328.76±82.44 vs TOT+PTNS group of 396.26±91.21. Detrusor pressure at peak flow(cmH2O) showed a greater improvement in TOT+PTNS than TOT alone 14.45±6.10 vs 11.89±54.49. At 12-week, urinary diary and quality of life improved in terms of urgent urination events, mean number of voids, urge symptoms and nocturia events. The Patient Impression of Global Improvement (PGI-I) after 3 months was better in combined group. CONCLUSIONS: Combined and sequential TOT+PTNS is more effective compared to TOT alone in MUI patients with prevalent SUI component.

Pathophysiologic mechanisms by which adenomyosis predisposes to postpartum haemorrhage and other obstetric complications.

Adenomyosis is characterized by the presence of ectopic endometrium within the myometrium. This features lead to structural changes in the surrounding myometrium and endometrium resulting also in functional changes. Alterations in the myometrium are suspected to lead to defective remodeling of spiral arteries during the early stages of decidualization resulting in altered vascular resistance and defective placentation. These alterations could play a common part in the association between adenomyosis and major obstetric complications. Latest epidemiological studies show that adenomyosis is associated with preterm birth, preeclampsia, IUGR and increased caesarean section rates, but very little is known of any underlying mechanism linking postpartum hemorrhage and adenomyosis. It is our opinion that adenomyosis may increase the risk of postpartum hemorrhage through several mechanisms that will be further clarified. Women with adenomyosis may require specific management during pregnancy and may benefit from wider understanding of the pathological mechanisms associated with this disease process.

Shock parameters and shock index during severe post-partum haemorrhage and implications for management: a clinical study.

The aim of this study was to report the association between shock severity, laboratory parameters and treatment in patients with severe post-partum haemorrhage (PPH) requiring the transfusion of ≥4 blood unit. Patients were divided into two groups: (1) conservative therapy and (2) emergency post-partum hysterectomy. The aggressive decision was always shared by two consultants. Out of 26,094 deliveries, severe PPH occurred in 34 (0.13%) women, emergency post-partum hysterectomy was required in 13 (0.05%), while 21 (0.08%) were treated conservatively. Grade of shock, shock index (SI) and the number of blood units transfused were significantly higher in the hysterectomy group. No statistically significant difference among the two groups was observed for haemoglobin and coagulation results. The severity of shock was associated with the therapeutic choice in the treatment of severe PPH. Therefore, grade of shock and SI should be taken into consideration by the leading obstetrician in the decision making process toward the emergency hysterectomy.Impact StatementWhat is already known on this subject? Primary post-partum haemorrhage (PPH) is the leading cause of maternal death in developing and industrialised countries. Emergency post-partum hysterectomy is considered a life-saving procedure performed when the women is experiencing a life-threatening haemorrhage.What the results of this study add? Therapeutic dichotomy between conservative and aggressive approach in severe PPH has not been defined, in particular emergency post-partum hysterectomy timing. Shock index (SI) has been proposed as an indicator of adverse maternal outcome. However, the association between shock parameters and advanced treatment modalities has not yet been reported. In our study, grade of shock, SI and the number of blood units transfused were significantly higher in the patients which needed hysterectomy suggesting that it may have a role in the decision making among conservative and aggressive treatment. No statistically significant difference was observed for haemoglobin and coagulation results.What the implications are of these findings for clinical practice and/or further research? Grade of shock and SI should be taken into consideration in the decision making process toward the emergency hysterectomy in severe PPH. The choice between conservative and aggressive treatment should be based on hemodynamic parameters that may represent, in more accurate way, the severity of blood loss. Nevertheless, these data need further confirmation in a larger study.

Implementation of the Four-Category Classification of Cesarean Section Urgency in Clinical Practice. A Prospective Study.

PURPOSE: This study is aimed at investigating the clinical efficacy of the 4-category classification of urgent cesarean section. METHODS: Women giving birth from September 2012 to December 2014 were prospectively investigated. Urgency C-section categories were color-coded: red - maternal/fetal life threat; yellow - maternal/fetal compromise, not life-threatening; and green - early delivery necessary. Results were audited. RESULTS: A total of 4,754 women gave birth in the period considered, 1,313 (27.6%) with C-section of which 867 were urgent. The code was red in 0.98% of women, and 91.5% of newborns were delivered ≤30'; yellow in 5.1%; and green in 11.7%. The mean decision-to-delivery interval (DDI) ± SD was 19.6 ± 9.5 min, 36.6 ± 15.3 (p < 0.01), and 80.3 ± 52.8 (p < 0.01), respectively; and mean umbilical pH was 7.24 ± 0.10, 7.29 ± 0.08 (p < 0.05), and 7.33 ± 0.04 (p < 0.01) in the red, yellow, and green groups, respectively. Two (4.2%) red and 4 (2.2%) yellow newborns were acidotic. Mean DDI ± SD decreased from 21.7 ± 9.7 min in the period September 2012 to February 2013 to 17.4 ± 9.7 min in the period February to December 2014 (p = NS). CONCLUSIONS: Four-category classification led to achieving the target time in >90% of category 1 emergency C-sections, and stratified newborns with significantly different acidosis levels.

Concentrations of polychlorinated dibenzodioxins, polychlorodibenzofurans, and polychlorobiphenyls in women of reproductive age in Italy: A human biomonitoring study.

BACKGROUND: Polychlorinated dibenzodioxins (PCDDs), polychlorodibenzofurans (PCDFs), and polychlorobiphenyls (PCBs) are persistent organic pollutants that represent a major concern for women of reproductive age because of the neurodevelopmental effects associated to perinatal exposure. OBJECTIVES: This study was aimed at characterizing exposure of women of reproductive age to PCDDs, PCDFs, and PCBs as a function of residence in different Italian Regions, in areas at presumable different environmental contamination and human exposure to these pollutants. METHODS: Study participants were enrolled in 2011-2012 in 6 Italian Regions representative of Northern, Central and Southern Italy; in each region, areas at presumed different exposure (rural, urban and industrial) were selected for enrolment. Each participant provided a serum sample for the analysis of PCDDs, PCDFs and PCBs. RESULTS: Median concentrations of PCDDs+PCDFs, DL-PCBs, NDL6-PCBs and NDL9-PCBs in serum samples were respectively 6.0 and 3.5 pgWHO-TE05/g fat, and 75 and 93ng/g fat. Age was the variable that most affected median serum concentrations. Age adjusted concentrations were found significantly different between geographical zones: women from Northern Italy showed the highest values, followed by Central and Southern Italy. PCDDs+PCDFs concentrations were significantly higher in the group of women residing in industrial areas compared to the group residing in rural areas. A clear diminishing temporal trend was observed compared to levels reported in previous studies. CONCLUSIONS: This study produced the largest dataset on serum concentrations of PCDDs, PCDFs and PCBs in women of childbearing age in Italy. RESULTS: confirmed that environmental and lifestyle factors may influence exposure to these contaminants and thereby the body burden. The observed marked temporal decline in body burden during three decades is in agreement with the general trend observed worldwide.

Adenomyosis: What the Patient Needs.

A panel of experts in the field of endometriosis expressed their opinions on management options in a 28-year-old patient, attempting pregnancy for 1 year, with severe cyclic pelvic pain and with clinical examination and imaging techniques suggestive of adenomyosis. Many questions this paradigmatic patient may pose to the clinician are addressed, and all clinical scenarios are discussed. A decision algorithm derived from this discussion is also proposed.

Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentre RCT.

STUDY QUESTION: Is the combined excisional/ablative technique for the treatment of ovarian endometriomas better than the traditional stripping technique in terms of recurrence rate? SUMMARY ANSWER: There is no evidence that the combined excisional/ablative technique is better than the traditional stripping technique, as similar recurrence rates were observed for the two techniques. WHAT IS KNOWN ALREADY: The stripping technique is associated with better results compared with ablative, non-excisional techniques for the treatment of ovarian endometriomas. Excisional techniques, such as stripping, have, however, been associated with reduced ovarian reserve as evaluated with anti-Mullerian hormone, and surgical techniques that better preserve the ovarian reserve are needed. STUDY DESIGN, SIZE, DURATION: A prospective, multicentre, randomized blinded clinical trial was carried out on 51 patients with bilateral endometriomas larger than 3 cm. For each patient, serving as her own control, one ovary was randomized to the stripping technique and the contralateral to the combined excisional/ablative technique. Patients were enrolled between January 2013 and April 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients of reproductive age with pelvic pain and/or infertility affected by bilateral endometriomas larger than 3 cm were included (n = 51). The patients underwent laparoscopic removal of endometriomas with two different surgical techniques performed at either side after random assignment: complete removal by stripping on one side versus the combined technique, consisting of partial excisional cystectomy followed by completion with ablative surgery using bipolar coagulation, on the other side. Post-operative follow-up was performed at 1, 3 and 6 months after surgery for the evaluation of endometrioma recurrence (primary outcome) and of antral follicle count (AFC) and ovarian volumes (OVs) to assess ovarian reserve (secondary outcome). MAIN RESULTS AND THE ROLE OF CHANCE: Recurrence rates were 5.9% for the stripping technique versus 2.0% for the combined technique (odds ratio 3.00; 95% confidence interval: 0.24-157.5; P = 0.62). AFC in the ovaries treated with the stripping technique did not differ significantly from AFC in ovaries treated with the combined technique at all follow-up visits, whereas OV was significantly lower after the combined technique at the 6-month follow-up visit (P = 0.04). LIMITATIONS, REASONS FOR CAUTION: A major limitation of this study is the small sample size and particularly for ovarian reserve, the secondary outcome, for which no formal sample size calculation was performed. The lower-than-expected recurrence rates in the present series may be related to the shorter follow-up in our study compared with most studies in the literature. Further studies with larger sample sizes and longer follow-up are needed to confirm the findings of this study. The combined technique using CO2 laser energy instead of bipolar coagulation should also be evaluated. WIDER IMPLICATIONS OF THE FINDINGS: The traditional excisional technique, i.e. the stripping technique, should still be considered the gold standard approach for the surgical treatment of endometriomas. STUDY FUNDING/COMPETING INTERESTS: No commercial funding was received. The authors report no relevant conflict of interest. TRIAL REGISTRATION NUMBER: ANZCTR number ACTRN12614000653662. TRIAL REGISTRATION DATE: 23 June 2014. DATE OF FIRST PATIENT'S ENROLMENT: 1 January 2013.

Current exposure of Italian women of reproductive age to PFOS and PFOA: A human biomonitoring study.

Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) concentrations were determined in serum samples collected in 2011-2012 from 549 nulliparous Italian women of reproductive age who resided in six different Italian Regions. Assessment of exposure to perfluorinated compounds was part of a large human biomonitoring study (Project Life Plus "Womenbiopop") that aimed at examining the exposure of women of reproductive age to priority organic pollutants. The median concentrations of PFOS and PFOA were 2.43, and 1.55 ng g(-1), respectively. Significant differences in the concentrations of both compounds were observed among the six Regions. Women from central Italy had the highest levels of both compounds, followed by women from northern Italy, and southern Italy. No differences in the PFOS concentrations were found between women from urban/industrial areas and women from rural areas, whereas the levels of PFOA were significantly higher in women residing in urban/industrial areas than in women residing in rural areas. Taken together, the observed concentrations confirm that the overall exposure of the Italian population is among the lowest observed in industrialized countries. A downward temporal trend in exposure was observed for both compounds when comparing the results from the present study with those assessed in a study conducted in 2008.

How to Manage Bowel Endometriosis: The ETIC Approach.

A panel of experts in the field of endometriosis expressed their opinions on management options in a 35-year-old patient desiring pregnancy with a history of previous surgery for endometrioma and bowel obstruction symptoms. Many questions that this paradigmatic patient may pose to the clinician are addressed, and various clinical scenarios are discussed. A decision algorithm derived from this discussion is proposed as well.

Femoral nerve injury complicating surgery for gynecologic cancer.

OBJECTIVE: The aim of this study was to report the incidence, severity, and factors associated with femoral nerve injury during gynecologic cancer surgery. METHODS: All patients who underwent abdominal surgery for gynecologic cancer entered the study. A retrospective review of the medical records was carried out for patients operated on from 2003 to April 2011. After this analysis, the use of the Bookwalter retractor was modified and the data were prospectively recorded. RESULTS: In the first period, femoral nerve injury was observed in 11 (2.7%) of 406 patients, occurring with a significantly higher frequency when the Bookwalter retractor was used (5.1% vs 0%, P < 0.01) and when pelvic lymphadenectomy was performed (5.1% vs 0.9%, P < 0.01). The analysis of the 212 patients (52.2%) in the Bookwalter group showed higher frequency of nerve injury in the patients undergoing pelvic lymphadenectomy (7.8% vs 2.0%, P = 0.05). In the second period, femoral nerve injury was observed in 1 (0.7%) of 132 patients operated on and in 1 (2.3%) of 43 patients (32.6%) in the Bookwalter group. When comparing the 2 periods, the lesser use of the Bookwalter retractor and the reduced time of maximal traction of the pelvic blades decreased the nerve injury rate from 2.7% to 0.7% and, in the Bookwalter group, from 5.1% to 2.3%. These results, although not statistically significant, are clinically relevant. CONCLUSIONS: Femoral nerve injury during gynecologic cancer surgery was associated with the Bookwalter retractor. The pelvic blades of the retractor may exert a compression on the nerve. The weakened muscles suggest that the nerve compression occurred intrapelvically over the iliacus muscle. Shortening the time of maximal traction of the pelvic blades reduced the incidence of femoral nerve injury. When performing gynecologic surgery with the use of the Bookwalter retractor, care must taken with the placement of the pelvic blades.

Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma.

OBJECTIVE: The purpose of this study was to explore in greater depth the outcomes of the Italian randomized trial investigating the role of pelvic lymphadenectomy in clinical early stage endometrial cancer. In the attempt to identify the patients with poorer prognosis, the impact of age and body mass index were also thoroughly investigated by cancer-specific survival (CSS) analyses. STUDY DESIGN: Survival outcomes of trial patients were analyzed in relation to age (≤65 years and >65 years) in the 2 arms (lymphadenectomy and no lymphadenectomy) and in the whole population of the trial. RESULTS: Univariate and multivariable analyses of CSS and overall survival (OS) of patients showed that age >65 years is a strong independent poor prognostic factor (5-y OS 92.1% and 78.4% in ≤65 years and >65 years patients, respectively, P < .0001; 5-y CSS 93.8% and 83.5% in ≤65 years and >65 years patients, respectively, P = .003). Among women ≤65 years, node negative patients had 94.4% 5-y OS and 96.3% 5-y CSS vs 74.3% 5-y OS and 74.3% 5-y CSS for node positive patients (P = .009 and P = .002, respectively), while among women >65 y, node negative patients had 75.7% 5-y OS and 83.6% 5-y CSS vs 74.1% 5-y OS and 83.3% 5-y CSS for node positive patients (P = .55 and P = .58, respectively). Univariate and multivariable survival analyses in the whole trial population showed that older age, and higher tumor grade and stage were significantly associated to a worse prognosis. CONCLUSION: Older women faced an intrinsic poorer survival whether or not they underwent lymphadenectomy, and, unexpectedly, irrespective of the presence of nodal metastasis. Only in older patients was obesity (body mass index >30) significantly associated with scarce prognosis.

Postpartum fever in the presence of a fibroid: Sphingomonas paucimobilis sepsis associated with pyomyoma.

BACKGROUND: Pyomyoma is a life-threatening complication of uterine leiomyoma. It may occur in post- menopausal women, during pregnancy and in the postpartum period. Fever may be the only manifestation during the early stages of the disease. We detail the first reported case of postpartum pyomyoma-related sepsis due to Sphingomonas paucimobilis, a Gram-negative bacillus that is gaining recognition as an important human pathogen. CASE PRESENTATION: A woman presented with an asymptomatic uterine fibroid and a two-week history of fever during the postpartum period. Suppurative uterine leiomyoma was diagnosed, and blood cultures grew Sphingomonas paucimobilis. The myoma was surgically removed from the uterus without hysterectomy. Intravenous antimicrobial therapy was given for fifteen days, and the patient was discharged from hospital in good condition. CONCLUSION: Pyomyoma should be considered in broad differential diagnosis of postpartum fever. This case highlights a unique disease manifestation of S. paucimobilis, an emerging opportunistic pathogen with increasing significance in the nosocomial setting.

Nerve-sparing class III-IV radical hysterectomy: urodynamic study and surgical technique.

OBJECTIVE: The aim of this study was to demonstrate the impact of the nerve-sparing radical hysterectomy on the bladder function. METHODS: Patients with cervical cancer stage 1B1 to IIB, who underwent type 3 to 4 nerve-sparing radical hysterectomy, were evaluated with urodynamic test before and within 6 months from surgery. Stage IB2 to IIB patients were treated with platinum-based neoadjuvant chemotherapy. Bladder catheter was removed in postoperative day 4, and patients were educated to clean intermittent self-catheterization. Urinary symptoms were evaluated with a questionnaire administered before and 3, 6, and 12 months after surgery. Patients treated with adjuvant chemoradiotherapy were excluded from the study. RESULTS: Fifteen patients (stage IB1, 7; IB2, 3; and IIB, 5) completed the study. Eight (53%) patients were treated with neoadjuvant chemotherapy. Bilateral nerve sparing was feasible in 13 (87%) patients, unilateral in 2 (13%). At postoperative day 10, only 3 (20%) patients continued intermittent self-catheterization. Before surgery, 1 (6.2%) patient had urodynamic symptoms of incontinence, and 3 (20%) had overactive bladder detrusor. Postoperative urodynamic study (median, 4 months; range, 3-6) showed reduced detrusor activity in 8 (53%), overactive detrusor in 4 (27%), and normal profile in 3 (20%) patients. Reduced bladder sensation was observed in 2 (12.5%), and residual urine more than 30% of bladder capacity in 2 (12.5%) patients, respectively. No patient showed de novo incontinence. Bladder compliance was unchanged. CONCLUSIONS: The separation of the hypogastric nerve from the parametrium is a feasible surgical step, which can be implemented in the radical hysterectomy technique in different clinical settings. The comparative urodynamic study showed a mild functional impairment in the early postoperative period. The most frequent finding was the reduced detrusor activity observed during the voiding phase, consistent with the straining needed to void reported in the questionnaire. These data suggest that a mild bladder impairment occurs despite the conservation of the hypogastric nerve.

Endometrial cancer: prognostic significance of risk classification based on pre-intraoperative findings.

PURPOSE: The aim of this study was to determine whether a pre-intraoperative prognostic classification of endometrial cancer (EC) patients may accurately predict prognosis. METHODS: Prognostic factors achievable before and during surgery (histotype, grade, myoinvasion, cervical spread, abdominal spread) were utilized to classify patients in low-risk (endometrial adenocarcinoma, grade 1-2, myoinvasion <50%, no evidence of abdominal spread), and in intermediate/high risk (serous papillary and clear cell, grade 3, myoinvasion >50%, cervical invasion, abdominal spread). Risk classification obtained pre-intraoperatively was compared with the classification obtained from definitive surgical-pathological assessment in 130 consecutive patients with EC treated with surgery. RESULTS: Pre-intraoperative risk assessment correctly identified risk classification in 125 (96%) patients; sensitivity, specificity, PPV and NPV were 98%, 94%, 94%, and 98%, respectively. Median follow-up was 38 months (range 6-93), and 14 (10%) patients relapsed (median time 14 months, range 3-60). Relative risk of relapse was higher in intermediate/high-risk patients with both classifications (pre-intraoperative RR 3.37, CI 0.99-11.5; surgical-pathological RR 4.56, CI 1.2-17.3). As regards survival 11 patients have died, 6 due to endometrial cancer and 5 due to intercurrent disease. Five-years DFS according to pre-intraoperative assessment was 89% and 71% for low-risk and intermediate high-risk patients (p = 0.028), respectively; according to definitive assessment was 91% and 70% for low-risk and intermediate/high-risk patients (p = 0.009), respectively. CONCLUSION: This classification, giving an accurate risk and prognostic estimate with parameters routinely utilized in clinical practice, may help the surgeon when undertaking the decision to perform limited or extended surgical staging according to tumor and patient characteristics.

Oral estroprogestins after laparoscopic surgery to excise endometriomas: continuous or cyclic administration? Results of a multicenter randomized study.

STUDY OBJECTIVE: To evaluate continuous (CON) compared with cyclic (CYC) administration of combined oral estroprogestins for 6 months after laparoscopic excision of ovarian endometriomas associated with pain. DESIGN: Multicenter, prospective, randomized trial (Canadian Task Force classification I). SETTING: Tertiary care university hospitals. PATIENTS: Fifty-seven women aged 18 to 40 years with ovarian endometriomas associated with moderate to severe pelvic pain who underwent laparoscopic excision of the disease. INTERVENTIONS: Patients were randomized to receive postoperative estroprogestins for 6 months, administered as either a CON or CYC regimen. MEASUREMENTS AND MAIN RESULTS: At 3, 6, 12, and 24 months postoperatively, patients were evaluated for recurrence of endometriomas (defined as cysts >3 cm in greatest diameter) using ultrasonography, for recurrence of pain using a visual analog scale, and for patient satisfaction. After a minimum follow-up of 12 months (mean, 22 months), at intent-to-treat analysis, no endometrioma recurrence was observed in the CON group, whereas there was recurrence in 1 patient (4%) in the CYC group. Pain recurred in 5 and 9 patients, respectively (17% vs 32%; p = .23). Compared with pretreatment values, pain scores improved in both groups, with no significant difference between the 2 groups. Most patients in both groups were either satisfied or very satisfied, with no significant difference between treatment groups. However, compared with the CYC group, significantly more patients in the CON group experienced moderate to severe adverse effects, and therapy was discontinued (41% vs 14%; p = .03). CONCLUSIONS: Although both regimens were equally effective insofar as postoperative pain and recurrence of endometrioma, when compared with the CYC regimen, the CON regimen seems to be associated with significantly more adverse effects and discontinuation rates.

Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial.

BACKGROUND: Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but the clinical impact of lymphadenectomy has not been addressed in randomized studies. We conducted a randomized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to standard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival. METHODS: From October 1, 1996, through March 31, 2006, 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were randomly assigned to undergo pelvic systematic lymphadenectomy (n = 264) or no lymphadenectomy (n = 250). Patients' clinical data, pathological tumor characteristics, and operative and early postoperative data were recorded at discharge from hospital. Late postoperative complications, adjuvant therapy, and follow-up data were collected 6 months after surgery. Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis. All statistical tests were two-sided. RESULTS: The median number of lymph nodes removed was 30 (interquartile range = 22-42) in the pelvic systematic lymphadenectomy arm and 0 (interquartile range = 0-0) in the no-lymphadenectomy arm (P < .001). Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy (81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm, P = .001). Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm (13.3% vs 3.2%, difference = 10.1%, 95% confidence interval [CI] = 5.3% to 14.9%, P < .001). At a median follow-up of 49 months, 78 events (ie, recurrence or death) had been observed and 53 patients had died. The unadjusted risks for first event and death were similar between the two arms (hazard ratio [HR] for first event = 1.10, 95% CI = 0.70 to 1.71, P = .68, and HR for death = 1.20, 95% CI = 0.70 to 2.07, P = .50). The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms (81.0% and 85.9% in the lymphadenectomy arm and 81.7% and 90.0% in the no-lymphadenectomy arm, respectively). CONCLUSION: Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.