Franco Alessandri

Unidirectional Barbed Suture versus Continuous Suture with Intracorporeal Knots in Laparoscopic Myomectomy: A Randomized Study

STUDY OBJECTIVE To estimate the effectiveness of unidirectional knotless barbed suture and continuous suture with intracorporeal knots in the repair of uterine wall defects during laparoscopic myomectomy. DESIGN Randomized clinical study (Canadian Task Force Classification I). SETTING Single-center study in a university hospital. PATIENTS This study enrolled 44 women who underwent laparoscopic myomectomy. INTERVENTIONS In accord with to the randomization, the uterine wall defects were closed either with a continuous suture with intracorporeal knots (group V) or a unidirectional knotless barbed suture (group L). MEASUREMENTS AND MAIN RESULTS The time required to suture the uterine wall defect was significantly lower in group L (11.5 ± 4.1 minutes) than in group V (17.4 ± 3.8 minutes; p <.001). However, no significant difference was observed in the operative time between the 2 study groups. The intraoperative blood loss was significantly lower in group L than in group V (p =.004). The degree of surgical difficulty was significantly lower in group L (3.7 ± 1.1) than in group V (6.1 ± 2.1; p <.001). CONCLUSION The unidirectional knotless barbed suture may facilitate the suture of uterine wall defects during laparoscopic myomectomy. When compared with continuous suture and intracorporeal knots, the barbed suture reduces the time required to suture the uterine wall defect and the intraoperative blood loss.

Treatment of pain associated with deep endometriosis: alternatives and evidence.

Pain is the most evident clinical manifestation of deep infiltrating endometriosis (DIE). Several hormonal and immunologic mechanisms are markedly altered in DIE compared with superficial peritoneal and ovarian endometriosis, and may explain its most aggressive behavior and the presence of severe pain symptoms. Hormonal therapies, such as combined hormonal contraceptives and progestogens, should be regarded as first-line treatment, as they are efficacious, safe, and well tolerated. Gonadotropin-releasing hormone agonists may be used in patients with symptoms persisting after the administration of first-line therapies. Scanty literature is available for danazol treatment in patients with DIE and, however, it has become less popular due to the high rates of androgenic adverse events (AEs). The partial relief of pain that often is achieved with available therapies and its recurrence after the suspension of the treatment have brought to the development of new therapies (such as aromatase inhibitors, oral GnRH antagonists) that are currently under investigation. Surgical excision of DIE should be considered in patients with pain symptoms persisting after first-line hormonal therapies. The benefits of surgery in terms of pain improvement should be always balanced with the risk of intraoperative complications and for this reason surgical cases should be referred to tertiary centers for the treatment of DIE. A multidisciplinary approach is mandatory in patients with DIE involving the bowel and/or the urinary tract.

Pharmacokinetics and toxicity of antimuscarinic drugs for overactive bladder treatment in females.

Introduction: Antimuscarinics (AMs) are the mainstay of pharmacological treatment of overactive bladder (OAB), a symptom complex defined by the presence of urinary urgency, usually associated with frequency and nocturia, with or without urgency urinary incontinence. The AMs used to treat OAB differ in their pharmacological profiles, which may affect their potential for causing adverse effects (AEs). Areas covered: The present article aims to review the literature about pharmacokinetics (PK) of the different AMs used in the treatment of OAB. Furthermore, the AEs related to the use of these drugs and their incidence are presented. This systematic review is based on material searched and obtained via Medline, Pubmed and EMBASE up to March 2012 using the search terms “adverse events, pharmacokinetics, tolerability” in combination with “darifenacin, fesoterodine, imidafenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium.” Expert opinion: Antimuscarinics are the first-line pharmacological treatment for OAB. Despite the development of new molecules that improve their efficacy/safety profile, there are some drugs that are pharmacokinetically more appropriate to be prescribed in specific populations such as patients with neurological disease or the elderly. Moreover, research should be encouraged in evaluating antimuscarinics in conjunction with other drugs such as estrogens or beta-agonists. The identification of prognostic criteria for pharmacological therapy would be helpful.

Monoclonal antibodies therapies for ovarian cancer

Introduction: Despite aggressive debulking surgery, intraperitoneal therapies and the use of new drugs for chemotherapy, patients with ovarian cancer (OC) still have poor prognosis and, therefore, new strategies for its management are needed. Molecular-targeted agents can be considered a new option in drug research. Several antigens related to OC have been isolated and they could be potential target of monoclonal antibodies (mAbs); therefore, different mAbs have been developed and are emerging as new potential OC treatments. Areas covered: This article aims to review the literature on the use of mAbs in the treatment of OC. The purposes of this manuscript are to offer a brief explanation of the mechanisms of action of mAbs and to help readers in understanding the current role of mAbs in the treatment of OC. Expert opinion: A deeper knowledge of the molecular biology of OC has brought new developments in targeted therapies. Among these therapies, bevacizumab demonstrated the higher clinical efficacy. Further larger trials are needed to better define the role of the other mAbs in OC treatment. There is a strong need to identify and validate robust biomarkers for a more focused patient selection and for tailoring therapies, optimizing dose and assessing response.

Three-month treatment with ulipristal acetate prior to laparoscopic myomectomy of large uterine myomas: a retrospective study.

OBJECTIVE To assess the usefulness of 3-month treatment with ulipristal acetate (UPA) before laparoscopic myomectomy of large uterine myomas. STUDY DESIGN This retrospective analysis of a prospectively collected database included women of reproductive age requiring laparoscopic myomectomy with the following characteristics: FIGO type 3, 4 or 5 myomas; largest diameter of the main myoma ≥10cm; number of myomas ≤3; largest diameters of the other myomas ≤5cm (second myoma) and ≤3cm (third myoma). Patients either underwent direct surgery (group S) or were treated before surgery with UPA for 3 months (group UPA). RESULTS The mean (±SD) intraoperative blood loss was lower in group UPA (507.1±214.9ml) than in group S (684.2±316.8; p=0.012). The total operative time was lower in group UPA (137.6±26.8min) than in group S (159.7±26.8min; p<0.001); there was no significant difference in the suturing time between the two study groups (p=0.076). Hemoglobin drop was lower in group UPA (1.1±0.5g/dl) than in group S (1.3±0.7g/dl; p=0.034). Six patients in group S and no patient in group UPA required postoperative blood transfusions (p=0.031). Complications were not different between the two groups (p=0.726). Moreover, preoperative treatment with UPA caused a significant increase in hemoglobin levels (11.9±1.6g/dl) compared with baseline (9.1±1.1g/dl; p<0.001). CONCLUSION A 3-month treatment with UPA before laparoscopy for large uterine myomas decreases intraoperative blood loss, hemoglobin drop, postoperative blood transfusion and length of surgery.

Ulipristal Acetate Before High Complexity Hysteroscopic Myomectomy: A Retrospective Comparative Study

STUDY OBJECTIVE To evaluate the efficacy of preoperative treatment with ulipristal acetate (UPA) in patients undergoing high complexity hysteroscopic myomectomy. DESIGN Retrospective analysis of a prospectively collected database (Canadian Task Force classification II-2). SETTING University teaching hospital. PATIENTS Patients of reproductive age requiring hysteroscopic myomectomy with STEPW (size, topography, extension, penetration, and wall) score 5 or 6. INTERVENTIONS Patients included in the study either underwent direct surgery (group S) or received a 3-month preoperative treatment with UPA (group UPA). Based on a power calculation, 25 patients were required in each study group. MEASUREMENTS AND MAIN RESULTS Myoma characteristics were similar in the 2 study groups. The 3-month UPA treatment caused a 21.9% (±10.3%) mean (±SD) percentage decrease in myoma volume. The number of complete resections (primary outcome of the study) was higher in group UPA (92.0%) than in group S (68.0%; p = .034). The operative time was lower in group UPA than in group S (p = .048), whereas there was no significant difference in fluid balance between the 2 study groups (p = .256). The incidence of complications was similar in the 2 groups (p = .609). Patient satisfaction at 3 months from surgery was higher in group UPA than in group S (p = .041). CONCLUSION A 3-month preoperative treatment with UPA increases the possibility of complete resection in high complexity hysteroscopic myomectomy. It decreases the operative time and improves patient satisfaction at 3 months from surgery.

Periurethral Injection of Polyacrylamide Hydrogel for the Treatment of Stress Urinary Incontinence: The Impact on Female Sexual Function

INTRODUCTION Urinary incontinence can negatively affect sexual function. AIM To investigate sexual function in female patients treated for urodynamic stress incontinence (USI) by periurethral injections. METHODS This double-center prospective study included 29 female patients who were treated for USI by periurethral injections of polyacrylamide hydrogel (Bulkamid(®); Ethicon Womens Health and Urology, Contura, Denmark). MAIN OUTCOME MEASURES Patients answered the International Consultation on Incontinence Questionnaire short form, the Incontinence Impact Questionnaire, and the Patient Global Improvement Impression. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) was used to evaluate sexual function at baseline and at 1-year follow-up. Patients were also asked to rate their sexual activity by using a 10-mm visual analog scale at baseline and at 12-month follow-up. Subjective and objective success was examined. RESULTS All patients were discharged on the same day of treatment and there was no intraoperative complication. At 1-year follow-up, the subjective success rate was 89.7% and the objective success rate was 79.3%. At 1 year from the first treatment, all the 23 sexually active patients continued to have regular sexual life. Six women reestablished sexual activity after the treatment. The total PISQ-12 scores showed a significant improvement in quality of sexual life of patients who were sexually active before surgery. CONCLUSIONS Periurethral injections of polyacrylamide hydrogel to treat USI are clinically effective and safe. These surgical procedures cause significant improvements in sexual function and sexual satisfaction of patients.

Bevacizumab for the treatment of cervical cancer

ABSTRACT Introduction: Cervical cancer is still a major cause of morbidity and mortality in women. Early stages and locally advanced cervical cancer are currently treated respectively with surgery and chemoradiation with good prognosis. Persistent, recurrent and metastatic cervical cancers have a poor prognosis. Angiogenesis has been identified as a crucial factor for cervical cancer growth. Recently, research has increasingly focused on the development of targeted therapies, such as anti-angiogenic drugs. Amongst such drugs, bevacizumab, a recombinant humanized monoclonal antibody has been the subject of extensive investigation, including its use in cervical cancer. This was recently approved for the treatment of patients with metastatic, recurrent, or persistent cervical cancer. Areas covered: The aim of this review is to discuss the role of bevacizumab in both locally advanced and metastatic or recurrent cervical cancer and to analyze the studies that have led to the approval of bevacizumab in cervical cancer. Expert opinion: The use of bevacizumab in combination with other chemotherapies in cervical cancer has been proven safe and effective, with a significant improvement in overall survival of patients with advanced cervical cancer. Combination therapy using bevacizumab has been demonstrated to increase toxicity rates but it does not impair patient’s quality of life.

Symptomatic endometriosis of the posterior cul-de-sac is associated with impaired sleep quality, excessive daytime sleepiness and insomnia: a case–control study

OBJECTIVE To assess the impact of endometriosis of the posterior cul-de-sac on quality of sleep, average daytime sleepiness and insomnia. STUDY DESIGN This age-matched case-control study was conducted in a tertiary referral centre for the diagnosis and treatment of endometriosis between May 2012 and December 2013. It included 145 women with endometriosis of the posterior cul-de-sac (cases; group E) and 145 patients referred to our Institution because of routine gynaecologic consultations (controls; group C). This study investigated whether sleep is impaired in patients with endometriosis of the posterior cul-de-sac. Sleep quality, daytime sleepiness and insomnia were assessed using the following self-administered questionnaires: the Pittsburgh Sleep Quality Index, the Epworth sleepiness scale and the Insomnia Severity Index, respectively. The primary objective of the study was to evaluate sleep quality in the two study groups. Secondary outcomes of the study were to assess average daytime sleepiness and insomnia in the two study groups. RESULTS The prevalence of poor sleep quality was significantly higher in group E (64.8%) than in group C (15.1%; p<0.001). The prevalence of excessive daytime sleepiness was significantly higher in group E (23.4%) than in group C (12.9%; p=0.033). Patients of group E experienced subthreshold insomnia (29.0%) and moderate clinical insomnia (16.6%) significantly more frequently than patients in group C (24.4% and 5.0%; p=0.002). CONCLUSION A substantial proportion of women with endometriosis of the posterior cul-de-sac experiences poor sleep quality, excessive daytime sleepiness and insomnia.

Effect of presurgical local infiltration of levobupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecological surgery

Patients undergoing laparoscopic surgery require close attention to providing adequate pain management. This randomized, double-blind, controlled study was designed to determine whether infiltrating the surgical field preoperatively with levobupivacaine, which is as effective as bupivacaine but causes fewer cardiovascular and central nervous system problems, would reduce the frequency, intensity, and duration of postsurgical wound pain in women treated for benign gynecologic disorders. Thirty-seven women undergoing laparoscopic surgery for benign conditions received an injection of 7 mL of a solution containing 5 mg/mL levobupivacaine 15 minutes before skin incision, whereas 37 others received the same volume of physiological saline. All incisional sites were infiltrated. An open laparoscopy technique with open step-by-step access was used for laparoscopy. Pain intensity was estimated using a 10-point visual analog scale 6, 12, and 24 hours postoperatively. The 2 groups were similar with regard to demographic and intraoperative characteristics. Mean pain intensity was significantly lower in the levobupivacaine group than in control patients 6 and 12 hours after surgery. Actively treated patients required less analgesia postoperatively, and the mean time to ambulation was significantly less than in control subjects. Women treated with levobupivacaine also had a shorter mean postoperative stay, but this difference was not statistically significant. Postoperative pain after laparoscopic gynecologic surgery, performed under general anesthesia, is substantially less-especially in the first 12 hours-if the surgical field is exposed preoperatively to levobupivacaine solution. Patients managed in this way require less postoperative analgesia.