Transbrachial approach to the treatment of uterine leiomyomas with embolization of the uterine arteries: a preliminary technical experience.

INTRODUCTION: Uterine leiomyomas are benign tumours; recently they have been managed with embolization of the uterine arteries. We analysed the technical feasibility, safety and efficacy of this treatment performed via an innovative transbrachial approach, rather than the traditional transfemoral approach. MATERIALS AND METHODS: Between 2009 and 2013, 115 patients were treated with embolization of the uterine arteries for one or more symptomatic leiomyomas. In 20 of these 115 patients, a transbrachial approach was used. Under ultrasound guidance, the left brachial artery was punctured. After having placed the tip of the angiography catheter at the level of L4 to check the aortic bifurcation, the uterine arteries were catheterised and embolized with calibrated particles. Data concerning exposure to radiation and the duration of the intervention were recorded for comparison between the two groups of subjects. Clinical controls and magnetic resonance imaging were complemented with echo-colour Doppler of the brachial artery to confirm the integrity and function of the vessel. RESULTS: The uterine arteries were catheterised easily in a mean time of 25″, compared to 72″ using the femoral approach. As far as exposure to radiation was concerned, the mean fluoroscopy time for the femoral approach was 21.7' [range 14.4-42.7'] compared to 17.6' [range 7.7-25.5'] for the transbrachial approach. The time of occupation of the angiography suite was 118' (range 95-155') with the femoral approach, compared to 92' (range 65-123') with the transbrachial approach. No immediate complications involving the brachial artery were recorded. DISCUSSION: In the treatment of symptomatic uterine fibromas, embolization of the uterine arteries performed via a transbrachial approach was shown to be safe and technically valid with regard to reducing the overall time of the intervention, ease of selective catheterisation, and shorter times spent in hospital, as well as being better accepted by patients.

Can HE4 predict platinum response during first-line chemotherapy in ovarian cancer?

Actually, in literature there are not valid tools able to predict the chemotherapy response during first-line ovarian cancer treatment. CA125 and human epididymis protein 4 (HE4) levels of consecutive single-institution patients with epithelial ovarian cancer (EOC) were measured during first-line chemotherapy and until 6 months follow-up. First, patients were divided into two groups according to a temporal criterion: patients treated during 2009 (group A: training group) and patients treated during 2010 (group B: verification group). At sixth months follow-up, patients were sub-classified, within both groups, as platinum resistant or platinum sensitive/intermediate, according to Response Evaluation Criteria in Solid Tumors criteria, and the serum marker courses were further analyzed in each subgroup. Moreover, we performed a logistic regression analysis to choose CA125 and HE4 levels that are best fitted to predict chemoresponse. A total of 76 patients were divided into two groups: group A (n = 42) and group B (n = 34). After 6 months of follow-up, 40 patients were classified as platinum sensitive/intermediate and 36 as platinum resistant. At third chemotherapy cycle, in platinum-resistant patients, HE4 levels were >70 pmol/L in 36 of 36 cases, although in platinum-sensitive/intermediate patients, HE4 levels were >70 pmol/L only in six of 40 cases (sensitivity 100 %, specificity 85 %). Moreover, HE4 reduction of almost 47 % at third chemotherapy cycle reached the sensitivity of 83 % with a specificity of 87 % (positive predictive value = 0.86, negative predictive value = 0.85) in predicting chemoresponse. On the contrary, CA125 values during chemotherapy did not result statistically significant in predicting platinum response. Our findings suggest that HE4 values during first-line chemotherapy could predict chemotherapy response in EOC patients.

Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial.

STUDY OBJECTIVE: To investigate the effects of music on anxiety and perception of pain during office hysteroscopy. DESIGN: Prospective randomized trial (Canadian Task Force classification I). SETTING: Major university medical center. INTERVENTIONS: Three hundred fifty-six patients were enrolled between July 2012 and January 2013. Hysteroscopy was performed in a dedicated ambulatory room, using vaginoscopy and without any type of anesthesia. A Bettocchi hysteroscope 5 mm in diameter was used. All procedures were performed by the same surgeon, a gynecologist with special interest in hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Data collected included age, body mass index, number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy). For each patient, vital parameters such as blood pressure, heart rate, and respiratory rate were recorded 15 minutes before the procedure and during hysteroscopy after traversing the cervix. Wait time before surgery and the duration of the procedure were also recorded. A completed Italian version of the state anxiety questionnaire (State-Trait Anxiety Inventory) and a visual analog scale (VAS) were administered to each patient before and after the procedure. The t test and Mann-Whitney U test was used when appropriate to compare the 2 groups. Statistical significance was accepted at p = .05. During surgery, systolic blood pressure and heart rate were significantly lower in the music group compared with the no music group. Women in the music group experienced significantly lower anxiety after hysteroscopy and less pain during the procedure, and a significant decrease in both anxiety and pain scores after hysteroscopy. Postoperative State-Trait Anxiety Inventory form Y1 and VAS scores were significantly lower in the music group. CONCLUSION: Music can be useful as a complementary method to control anxiety and reduce perception of pain. The patient is more relaxed and experiences less discomfort.

A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial.

OBJECTIVE: Laparoscopic entry techniques vary and still remain debated. We conducted a randomized control trial to compare three entry techniques. STUDY DESIGN: Women aged 18-70 years, nominated for laparoscopic surgery at University of Rome Campus Bio-Medico, were randomized into three different groups: Veress needle (VER), Direct trocar insertion (DIR) and Open technique (OP). For each group, minor complications (extra-peritoneal insufflation, trocar site bleeding, omental injury and surgical site infection), failed entry and time of entry of the main trocar were evaluated. Major complications were also considered. Between-group comparisons were performed using chi-square test. Significance P value was <0.05. RESULTS: A series of 595 consecutive procedures were included: 193 in the VER group, 187 in the DIR group and 215 in the OP group. Minor complications occurred in 36 cases: extraperitoneal insufflation (n=6) in the VER group only, site bleeding (n=2 in the VER group, n=2 in the DIR group and n=1 in the OP group), site infection (n=5 in the VER and n=6 in OP group), and omental injury (n=6 in the VER group and n=3 in the DIR group). Failed entry occurred in 4 cases of the VER group and 1 case of the DIR group. Mean time of entry was 212.4, 71.4 and 161.7s for the VER, DIR and OP groups respectively. Among major complications, one bowel injury resulted following the Veress technique. CONCLUSIONS: In our series, DIR and OP entry presented a lower risk of minor complications compared with VER. In addition, time of entry was shorter in DIR than with OP entry.

The role of novel biomarker HE4 in endometrial cancer: a case control prospective study.

The aim of the study was to explore the clinical value of serum human epididymis secretory protein E4 (HE4) and CA125 in endometrial carcinoma. From January 2010 to April 2012, serum specimens were collected from consecutive cases of endometrial carcinoma and from cases of uterus benign disease (control group). The CA125 normal value is considered less than 35 U/mL. Two HE4 cutoff are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the Mann-Whitney test for the CA125 and HE4 series. The level of statistical significance is set at p < 0.05. The sensitivity of CA125 in detecting endometrial cancer is 19.8 %, whereas the sensitivity of HE4 is 59.4 and 35.6 % for 70 and 150 pmol/L cutoff, respectively. Thus the specificity of HE4 is 100 % (positive predictive value = 100 %, negative predictive value = 71.52 and 61.31 % considering the two HE4 cutoff, respectively), whereas the CA125 specificity is 62.14 % (positive predictive value = 33.9 %, negative predictive value = 44.14 %) in detection of endometrial cancer. Combining CA125 and HE4, the sensitivity to detect endometrial cancer is 60.4 and 34.6 %, at HE4 cutoff of 70 and 150 pmol/L, respectively, with a specificity of 100 %. HE4 may be a new tool for preoperative evaluation and postoperative surveillance of endometrial cancer patients, with a positive predictive value = 100 %. HE4 at cutoff of 70 pmol/L yields the best sensitivity and specificity.

Can the preoperative HE4 level predict optimal cytoreduction in patients with advanced ovarian carcinoma?

OBJECTIVE: Optimal surgical outcome has been proved to be one of the most powerful survival determinants in the management of ovarian cancer patients. Actually, for ovarian cancer patients there is no general consensus on the preoperatively establishment of cytoreducibility. METHODS: Between January 2011 and June 2012 patients affected by suspicious advanced ovarian cancer, referred to the Department of Gynecology of Campus Biomedico of Rome were enrolled in the study. All patients had serum CA125 and HE4 measured preoperatively. After a complete laparoscopy to assess the possibility of optimal debulking surgery defined as no visible residual tumor after cytoreduction (RT=0), patients were submitted to primary cytoreductive surgery (Group A) or addressed to neoadjuvant chemotherapy (Group B). RESULTS: After diagnostic open laparoscopy, 36 patients underwent optimal primary cytoreductive surgery (Group A) and 21 patients were addressed to neoadjuvant chemotherapy (Group B). In our population, based on ROC curve, the HE4 value of 262pmol/L is the best cut-off to identify patients candidates to optimal cytoreduction with a sensitivity of 86.1% and a specificity of 89.5% (PPV=93.9% and NPV=77%). In addition, CA125 has a sensitivity of 58.3% and a specificity of 84% at cut-off of 414 UI/mL (AUC is 0.68, 95% C.I.=0.620 to 0.861). CONCLUSION: Our data indicate that preoperative HE4 is a better predictor for optimal cytoreduction compared to CA125. The best combination in predicting cytoreduction is HE4≤262 pmol/L and ascites <500mL with a sensitivity of 100% and a specificity of 89.5% (PPV=94% and NPV=100%).

Does HE4 have a role as biomarker in the recurrence of ovarian cancer?

Human epididymis protein 4 (HE4) was recently approved by the Food and Drug Administration to monitor recurrence or progressive disease in epithelial ovarian cancer in conjunction with CA125. This is the first prospective controlled study in literature evaluating the sensitivity and specificity of HE4 and CA125 in detecting recurrent ovarian cancer. Serum samples were obtained 24 h before surgery from 34 patients with suspicious recurrent ovarian cancer and from 34 patients with benign adnexal pathology, operated from November 2010 to November 2011 at University Campus Bio-Medico of Rome. The CA125 normal value is considered less than 35 U/mL. Two HE4 cut-off are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the parametric t test to compare the CA125 series and the Mann-Whitney test for the HE4 series. The level of statistical significance is set at p < 0.05. The CA125 sensitivity and specificity in detecting recurrent ovarian cancer is 35.29 and 58.82 %, respectively. The HE4 sensitivity is 73.53 and 26.47 %, for 70 pmol/L and 150 pmol/L cut-off, respectively. The HE4 specificity is 100 %. Combining CA125 and HE4 at cut-off of 70 pmol/L, the sensitivity to detect recurrent ovarian cancer is 76.47 % with a specificity of 100 %. The combination of CA125 and HE4 at cut-off of 70 pmol/L improves the overall sensitivity and specificity of CA125 alone, suggesting a useful application of HE4 in strategies for surveillance of ovarian cancer recurrence.

Real-time infrared thermography for ureter detection during hysterectomy.

BACKGROUND: Recognition of different anatomic structures might be difficult in the presence of diseases such as neoplasm or endometriosis that can subvert the anatomy. This can be a challenge for young surgeons approaching gynecologic surgery. The aim of the present study was to evaluate the effectiveness of infrared thermocamera to identify the anatomic structures in gynecologic surgery. MATERIALS AND METHODS: From February 2010 to May 2011, consecutive patients who required abdominal hysterectomy were considered for eligibility. During a procedure for benign disease, we evaluated the temperature difference between the ureter and infundibulopelvic vessel (experiment A). In patients with gynecologic cancer, the thermal gradient was determined between the iliac vessels and the ureter (experiment B). RESULTS: The data from 21 patients were recorded, 12 for experiment A and 9 for experiment B. We found a statistically significant difference between the ureter and vessels in both experiments (31.675°C ± 0.673°C for the ureter and 33.332°C ± 0.828°C for the infundibulopelvic vessel, P < 0.0001; 31.706°C ± 0.751°C for the ureter, 33.787°C ± 0.63°C for the iliac vein, and 33.784°C ± 0.639°C for the iliac artery, P < 0.0001). CONCLUSIONS: Infrared imaging allowed us to identify the anatomic structures in laparotomy, providing preliminary data for its application in laparoscopy.

A new type of absorbable barbed suture for use in laparoscopic myomectomy.

OBJECTIVE: To compare effectiveness, feasibility, and suturing time required between an absorbable barbed wire (V-Loc) uterine suture and a classic continuous suture with intracorporeal knots among women undergoing laparoscopic myomectomy. METHODS: From January 2010 to February 2011, women with single symptomatic intramural myoma were prospectively enrolled in a single-center study at a university hospital in Rome, Italy. A control group with characteristics meeting the criteria for study inclusion was retrospectively identified from the hospital databases. In the prospective group uterine wall defects were closed with V-Loc suture, whereas in the control group they were closed by classical continuous suture with intracorporeal knots. Data were analyzed via Student t test, Mann-Whitney U test, and Fisher exact test. RESULTS: The mean operative time was shorter in the V-Loc (51±18.1 min) than in the control (58±17.8 min) group. Suturing time was significantly lower in the V-Loc than in the control (9.9±4.3 versus 15.8±4.7 min; P=0.0004) group. Both intraoperative bleeding and drop in hemoglobin were significantly lower in the V-Loc group (P=0.0076 and P=0.0176, respectively). CONCLUSION: Use of a barbed suture may aid surgeons during laparoscopic suturing by reducing operative time, suturing time, and blood loss.

The use of novel hemostatic sealant (Tisseel) in laparoscopic myomectomy: a case-control study.

BACKGROUND: This is the first case-control study on the use of a fibrin sealant (Tisseel) on uterine suture during laparoscopic myomectomy (LM), with the primary endpoint to evaluate the intraoperative bleeding and postoperative blood loss. In addition, we evaluated the time required to achieve hemostasis using Tisseel and how much it can influence operative time. METHODS: From December 2009 to January 2011, consecutive patients older than 18 years with symptomatic isolate intramural myoma with maximal diameter B6 cm and ≥ 4 cm and with a sonographically diagnosed free myometrium margin ≥ 0.5 cm were included in the study. We selected from our institute's database a group of consecutive patients with homogeneous features of the study group, who underwent laparoscopic myomectomy without Tisseel application. RESULTS: Fifteen women with symptomatic myoma were enrolled in the study (group A). Regarding the control group (group B), we selected a homogenous group of 15 patients with the same preoperative characteristics of the study group. Mean operative time was 47.7 min and 62.1 min, for groups A and B respectively (p < 0.05). Mean time required to achieve complete haemostasis was 195.5 s in group A and 361.8 in control group B (p < 0.0001). Mean estimated blood loss was 111.3 mL and 230 mL in groups A and B, respectively (p < 0.05). Mean hemoglobin decrease was 1.36 g/dL and 2.04 g/dL in groups A and B, respectively (p < 0.05). CONCLUSIONS: The use of Tisseel during LM may represent a valid alternative solution for obtaining hemostasis, reducing intra- and postoperative bleeding. Furthermore, it may help the surgeon to obtain a rapid healing of the injured surfaces, probably reducing the use of electrocoagulationand traumatisms.

Update on urodynamic bladder dysfunctions after radical hysterectomy for cervical cancer.

INTRODUCTION: Bladder dysfunctions are a common sequela after radical hysterectomy (RH, former type III sec Piver) ranging from 8 to 80%. This discrepancy, probably, reflects the different bladder function evaluation methods utilized in literature. MATERIAL AND METHODS: We searched English-language medical reports published from 1952 to 2010, on MEDLINE. Inclusion criteria were: (1) studies of urological dysfunctions in patients with cervical cancer, treated with type III sec Piver (C2 sec Querleu) radical hysterectomy; (2) use of urodynamic measurement. RESULTS: The overall incidence of urodynamic bladder dysfunctions is 72%. Follow-up >12 months studies report a high incidence of overactive detrusor low compliance (34%). Eight out of 19 studies show a decrease of the maximal urethral closure pressure (MUCP). DISCUSSION AND CONCLUSIONS: Follow-up timing seems to be the major factor influencing the wide range of incidence of bladder dysfunction. Urodynamic data could help physicians to formulate appropriate evaluation and treatment for patients having urge incontinence (UI) after RH.

Feasibility of the use of novel matrix hemostatic sealant (FloSeal) to achieve hemostasis during laparoscopic excision of endometrioma.

STUDY OBJECTIVE: To evaluate the use of FloSeal, a 2-component (collagen granules and thrombin) topical hemostatic agent for the control of minor bleeding of the ovarian wall at the end of the laparoscopic stripping procedure for endometriomas. DESIGN: Pilot study. SETTING: Tertiary care university hospital. PATIENTS: Twenty consecutive patients who underwent laparoscopic excision of endometriomas were included in the study. INTERVENTIONS: Eight patients was allocated to FloSeal group, whereas the remaining 12 patients were allocated to the control group. MEASUREMENTS AND MAIN RESULTS: At the end of the laparoscopic stripping procedure for ovarian cyst (diameter between 3 and 6 cm), the ovarian cortex was carefully everted and thoroughly rinsed to identify the precise localization of bleeding spots. In the FloSeal group the sites of bleeding were covered with FloSeal under direct vision with a laparoscopic applicator. Gentle pressure on the ovary was applied for 5 minutes and subsequently bleeding sites were reexamined. In the control group hemostasis was obtained with conventional methods. Hemostasis was obtained in all cases by 3 minutes from FloSeal application in both study arms. The time of hemostasis was similar in control and FloSeal groups with a median time of 172 and 182 seconds, respectively. CONCLUSION: This preliminary series suggests that FloSeal may be used instead of bipolar electric coagulation after excision of ovarian endometriomas. Because the latter was identified by some authors as a possible cause of follicular damage, the use of FloSeal for bleeding control should be investigated in patients undergoing laparoscopic stripping of endometriomas.

Urologic function and urodynamic evaluation of urinary diversion (Rome pouch) over time in gynecologic cancers patients.

OBJECTIVE: To describe the urologic late complications and urodynamics outcome adopting teniamyotomies technique to create a low-pressure reservoir using the cecum, ascending colon and proximal part of the transverse colon without detubularization (Rome pouch). METHODS: Twenty-eight consecutive patients affected by gynecological cancer and submitted urinary diversion with "Rome pouch" technique were included. After 3 and 12 months from the surgical procedure patients were submitted to urodynamic evaluation of the neobladders. Excretory urography was performed in all patient. Abdominal X-ray, serum electrolytes, creatinine and cultures of the reservoir are obtained during every visit. Long-term urologic complications were recorded. Patient quality of life was assessed using a 10 cm grade visual analog scale (VAS). RESULTS: Urodynamics performed 12 months postoperatively showed that the mean maximum reservoir capacity was 439.9+/-58.9 cm H(2)O. The mean reservoir pressure at maximum capacity was 19.2+/-8.4 cm H(2)O (no contractive wave during the filling in any patient). The mean maximum closure pressure in the efferent tube, at maximum capacity, was 88.8+/-32.3 cm H(2)O. Continence was excellent for 26 (93%) and 23 (92%) patients at 3 and 12 months respectively. A total of 9 (32%) and 6 (24%) patients suffered late complications at 3 and 12 months follow-up respectively. However only one patient with pouch leakage underwent surgical pouch revision. CONCLUSION: Our experience demonstrated that Rome pouch creation with multiple teniamyotomies has good capacity with low internal pressure and good continence with a low rate of late urologic complications. Thus, comparing results to those of other continent pouch models, the Rome pouch technique represents a valid alternative.