Valentino Bergamini

A Critical Review on the Use of Recombinant Factor VIIa in Life-Threatening Obstetric Postpartum Hemorrhage

The objective of this review was to evaluate and summarize the current literature on the unlicensed use of the novel agent recombinant activated factor VII (rFVIIa) in the management of major postpartum hemorrhage. After a systematic electronic search without temporal limits on MEDLINE, EMBASE, OVID and SCOPUS, the bibliographic references of all retrieved studies and reviews were additionally assessed for further reports of clinical trials. Unpublished works were also identified by searching abstracts from the most eminent conferences on this topic. In total, there were 31 studies that fulfilled our inclusion criteria. These studies incorporated 118 cases of massive postpartum hemorrhage treated with rFVIIa. The median age of the patients was 31.4 years, and cesarean section appeared to increase the risk of postpartum hemorrhage. At a median dose of 71.6 mug/kg, rFVIIa was reported to be effective in stopping or reducing bleeding in nearly 90% of the reported cases. Based on the evidence from the literature, we give some recommendations on the use of rFVIIa in massive postpartum hemorrhage. Nevertheless, although these reports suggest the potential role of rFVIIa in treating massive postpartum hemorrhage refractory to standard therapy, we advise particular caution in interpreting these results, as they are derived from few and uncontrolled studies. Further evidence is needed using well-designed clinical trials to better assess the optimal dose, the effectiveness, and the safety of rFVIIa in such critical bleeding conditions.

The Use of Recombinant Activated FVII in Postpartum Hemorrhage

Severe bleeding remains a leading cause of morbidity and mortality in obstetrics. The first-line standard treatment of massive postpartum hemorrhage (PPH) includes medical measures directed at improving uterine tone, replacement of lost intravascular volume, blood and coagulation factors, and surgical or invasive procedures. Recently, a number of case reports or case series have reported the successful “off-label” use of recombinant activated factor VII (rFVIIa) in PPH unresponsive to conventional treatments. In this review, a critical analysis of the published literature on the use of rFVIIa in severe PPH was performed. Overall, a total of 272 PPH women were collected among the largest case series and/or international registries. No randomized controlled trials have been conducted in this area. Currently, the literature data suggest that, at a median dose of 81.5 μg/kg, rFVIIa is effective in stopping or reducing bleeding in 85% of the cases. Finally, on the basis of the evidence from the literature and on own experience, we included some recommendations and an algorithm on the therapeutic role of rFVIIa in the management of PPH.

Ultrasonographic measurement of thymus size in IUGR fetuses: a marker of the fetal immunoendocrine response to malnutrition

To test the hypothesis that intrauterine growth restriction (IUGR) is associated with decreased thymus size in the human fetus.

Bipolar Electrocoagulation versus Suture of Solitary Ovary after Laparoscopic Excision of Ovarian Endometriomas

STUDY OBJECTIVE To compare the functional ovarian damage associated with the use of bipolar coagulation versus ovarian suture after laparoscopic excision of ovarian endometriomas in patients with a solitary ovary. DESIGN Retrospective study (Canadian Task Force classification II-3). SETTING Tertiary care center. PATIENTS Forty-seven consecutive women with a single ovary and regular menses who underwent laparoscopic stripping of one or more ovarian endometriomas between June 1996 and June 2001. Intervention. Twenty-one patients had bipolar electrocoagulation (group A), while 26 had suturing of the ovary (group B). Plasma follicle-stimulating hormone (FSH) and estradiol levels were determined before surgery and re-evaluated at 3-, 6-, and 12-month follow-up. MEASUREMENTS AND MAIN RESULTS At 12-month follow-up, six patients (29%) in group A had oligo-amenorrhea versus three patients (12%) in group B (p = .14). Follicle-stimulating hormone levels between 10 and 20 mlU/mL were found in five patients (24%) in group A and in three patients (12%) in group B, whereas FSH levels above 20 mlU/mL were found in three patients (14%) in group A and in no patient in group B. Eight patients (38%) in group A had FSH levels greater than 10 mlU/mL versus three patients (12%) in group B (p = .042). Overall, repeated analysis of variance showed a marginally significant difference (p = .06) in FSH values between the two groups. CONCLUSION Our results suggest that bipolar electrocoagulation of the ovarian parenchyma after laparoscopic stripping of an endometriotic ovarian cyst adversely affects ovarian function.

Management of ureteral endometriosis: areas of controversy.

Purpose of review In this review we critically evaluate what we know and what we still do not know about pathogenesis, diagnosis and treatment of ureteral endometriosis, highlighting areas of controversy. Recent findings Recent studies have produced new insights into diagnostic and management options for ureteral endometriosis. Summary The diagnosis of ureteral endometriosis entails a high index of suspicion for the disorder. Imaging techniques are of limited value in providing an accurate depiction of extension of ureteral lesions. Preliminary results suggest that magnetic resonance urography is accurate in differentiating between intrinsic and extrinsic forms of ureteral involvement, but further studies are required to define its role in directing better treatment. Current controversies in the treatment of ureteral endometriosis are over whether segmental resection and anastomosis or ureterolysis are indicated, and whether minimal-access procedures are equally effective than their traditional open counterparts. Recent studies suggest that laparoscopic ureterolysis can be an effective treatment option in most patients with ureteral endometriosis but that recurrence rates are not negligible, as suggested in pioneering works. Successful application of laparoscopic surgery, even for procedures that have traditionally necessitated laparotomy, has been reported. Extensive experience with endourological techniques is prerequisite for success. Abbreviations IVP: intravenous pyelography; MRI: magnetic resonance imaging.

Midterm outcome of radiofrequency thermal ablation for symptomatic uterine myomas

BackgroundOver the past decade an increasing demand for uterine-sparing treatment to manage symptomatic uterine myomas has become apparent in women’s health care. A preliminary report showed that radiofrequency ablation (RFA) of uterine fibroids under laparoscopic guidance was a safe and effective minimally invasive approach with encouraging short-term results. The purpose of this study was to evaluate the midterm outcomes of radiofrequency ablation (RFA) of uterine myomas in terms of durability of symptom control and level of health-related quality of life.MethodsConsecutive women with symptomatic uterine myomas, no plans for future pregnancy, and who declined hysterectomy were offered RFA ablation of uterine fibroids under laparoscopic guidance. Only 25 patients who completed at least the one-year follow-up assessment were included in the study group. Follow-up evaluations were scheduled at 1, 3, 6, 9, and 12 months and thereafter annually following the procedure. Improvement in myoma-related symptoms and impact on quality of life were assessed using a validated questionnaire (UFS-QOL).ResultsThe median number of myomas treated per patient was 1 (range = 1–3). The median baseline volume of the dominant myoma was 76.8 cm3 (range = 14.8–332.8). No intraoperative or postoperative complications occurred. The median follow-up time was 24 months, with nine women completing three years of follow-up. The median reduction in myoma volume was 68.8% and 77.9% at six months and one year, respectively. No further change in fibroid size was observed at two years and three years. One year after the procedure, one woman (4%) underwent hysterectomy for recurrence of fibroid-related symptoms. Quality-of-life measures showed significant and durable improvement compared with baseline.ConclusionsRFA of symptomatic fibroids seems a valuable alternative to major surgery, with durable symptom relief for most patients and a low chance of recurrence at midterm.

Should adnexal mass size influence surgical approach? A series of 186 laparoscopically managed large adnexal masses

Objective  To evaluate the feasibility and safety of laparoscopic management of adnexal masses ≥10 cm in size.

Preoperative assessment of intestinal endometriosis: a comparison of Transvaginal Sonography with Water-Contrast in the Rectum, Transrectal Sonography, and Barium Enema

To evaluate the accuracy of Transrectal Sonography (TRS) and a new technique, Transvaginal Sonography with Water-Contrast in the Rectum (RWC-TVS), in the diagnosis of rectosigmoid endometriosis, and the accuracy of Barium Enema (BE) and RWC-TVS in the detection of intestinal stenosis due to endometriosis. In a prospective study, we compared the findings of TRS and RWC-TVS performed before surgery with the operative and pathologic findings in 61 consecutive patients who underwent laparoscopy or laparotomy for suspected rectosigmoid endometriosis. The accuracy of BE and RWC-TVS in the detection of intestinal stenosis was evaluated comparing the radiologic and ultrasonographic results with the macroscopic findings at surgery and pathology. RWC-TVS diagnosed rectosigmoid endometriosis with the same accuracy of TRS and was equally efficient as BE in the detection of a significant intestinal lumen stenosis. For the diagnosis of rectosigmoid endometriosis the sensitivity, specificity, positive and negative predictive values of TRS and RWC-TVS were 88.2% and 96%, 80%, and 90%, 95.7%, and 98%, and 57.1% and 81.8%, respectively. For the detection of intestinal stenosis the sensitivity, specificity, positive and negative predictive values of BE and RWC-TVS were 93.7% and 87.5%, 94.2% and 91.4%, 88.2% and 82.3%, and 97% and 94.1%, respectively. RWC-TVS is a new, simple technique for a single-step and accurate preoperative assessment of rectosigmoid endometriosis.

Infectious morbidity after total laparoscopic hysterectomy: does concomitant salpingectomy make a difference?

The study was aimed to test the hypothesis that preservation of the fallopian tubes at the time of total laparoscopic hysterectomy (TLH) increases the risk for postoperative infection. The study group consisted of 137 consecutive women undergoing TLH with conservation of the ovaries, who had concomitant bilateral total salpingectomy at the time of TLH. The control group included 145 women who had had TLH without salpingo‐oophorectomy before the study period. Women undergoing bilateral total salpingectomy at the time of TLH had a lower rate of infectious morbidity compared with those who had TLH alone (3/137 versus 14/145, P = 0.01). Multivariable analysis showed that bilateral total salpingectomy at the time of TLH and blood loss are independent predictors of infectious morbidity.

Assessment of pelvic endometriosis: correlation of US and MRI with laparoscopic findings.

Purpose.The purpose of this study was to evaluate the contribution of ultrasound (US) and magnetic resonance (MR) imaging in the diagnosis and local staging of endometriosis by comparing results with laparoscopic findings.Materials and methods.We evaluated 36 consecutive women with suspected or clinically diagnosed endometriosis. Thirty–two out of 36 patients met the following inclusion criteria: transabdominal and endocavitary (US) examination and MR imaging, followed by laparoscopy performed within 2 weeks. US and MR findings were classified based on location, number and morphology (small nodules, large nodules, laminar lesions, cystic lesions, complex lesions, adhesions, cul–de–sac obliteration).Results.Laparoscopy, considered the gold standard, identified 143 lesions in 32 patients. US detected 101 lesions, and MR detected 92 lesions, which were subsequently divided by morphologic appearance. Sensitivity and specificity of the two imaging techniques in the recognition of the different locations were 58% and 25%, respectively, for US and 56% and 50%, respectively, for MR imaging. Results of the two techniques in the different locations examined were similar, with the exception of lesions in the rectovaginal septum, which were better detected by US, and for adhesions and cul–de–sac obliteration, which were more easily detected by MR.Conclusions.Both US and MR are accurate in the diagnosis of endometriosis. There are no significant differences in staging of pelvic endometriosis between US and MR. US examination is the primary evaluation in cases of suspected disease and for the rectovaginal septum. MR examination is recommended for correct classification in doubtful cases and in cases of suspected extrapelvic lesions and adhesions.