Hysteroscopic myomectomy: The guidelines of the International Society for Gynecologic Endoscopy (ISGE).

OBJECTIVE: With this publication, the International Society for Gynecologic Endoscopy (ISGE) aims to provide the clinicians with the recommendations arising from the best evidence currently available on hysteroscopic myomectomy (HM). STUDY DESIGN: The ISGE Task Force for HM defined key clinical questions, which led the search of Medline/PubMed and the Cochrane Database. We selected and analyzed relevant English-language articles, published from January 2005 to June 2021, including original works, reviews and the guidelines previously published by the European Society for Gynecological Endoscopy (ESGE) and the American Association of Gynecologic Laparoscopists (AAGL), in which bibliographies were also checked in order to identify additional references, using the medical subject heading (MeSH) term "Uterine Myomectomy" (MeSH Unique ID: D063186) in combination with ''Myoma" (MeSH Unique ID: D009214) and ''Hysteroscopy" (MeSH Unique ID: D015907). We developed the recommendations through multiple cycles of literature analysis and expert discussion. RESULTS: The ISGE Task Force did develop 10 grade 1A-C and 4 grade 2A-C recommendations. For planning HM, evaluation of the uterus with saline infusion sonohysterography (SIS) or combined assessment by transvaginal ultrasound (TVUS) and diagnostic hysteroscopy is recommended (Grade 1A). The use of STEPW (Size, Topography, Extension of the base, Penetration and lateral Wall position) classification system of submucosal leiomyoma (LM) is recommended to predict the complex surgeries, incomplete removal of the LM, long operative time, fluid overload and other major complications (grade 1B). For type 0 LMs, in addition to resectoscopy (slicing technique), morcellation is recommended, being faster and having a shorter learning curve with respect to resectoscopy (grade 1C). For type 1-2 LMs, slicing technique is currently recommended (grade 1C). A fluid deficit of 1000 mL also in case of bipolar myomectomy with saline solution, in healthy women of reproductive age, contains low risk for major complications. Lower thresholds (750 mL) for fluid deficit should be considered in the elderly and in women with cardiovascular, renal or other co-morbidities (Grade 1B). CONCLUSION: HM is the most effective conservative minimally invasive gynecologic intervention for submucous LM. The set of 14 ISGE recommendations can significantly contribute to the success of HM and the safety of patients for whom the choice of appropriate surgical technique, as well as the surgeon's awareness and measures to prevent complications are of the utmost importance.

Pain Management During Office Hysteroscopy: A Survey of Hysteroscopists.

OBJECTIVE: Outpatient hysteroscopy can be a painful procedure for some patients and there is still no consensus regarding analgesia use. We evaluated which types and modalities of analgesia are most commonly used in a select group of hysteroscopists. STUDY DESIGN: A 15-item questionnaire was created to assess the use of routine analgesia during office hysteroscopy. The SurveyMonkey portal (https://www.surveymonkey.com/) was used to administer the questionnaire. Of the 400 hysteroscopists who were approached, 229 replied. RESULTS: Routine pre-procedural or intra-procedural analgesia was used by 34% of hysteroscopists (67% of these reported using NSAIDs, 12% paracetamol, 7% opioids 13.5% other). Among hysteroscopists who routinely used intra-procedural analgesia, 46.1% reported using a paracervical block, 15.4% used an intracervical blockage, 15.4% had the patient listen to music during the procedure, 3.8% used local anesthetics, as in a spray or gel on the surface of the cervix, and 19.2% used some other method. Regarding misoprostol use, 75% of hysteroscopists reported not using it routinely. CONCLUSION: Our results are consistent with poor evidence from published studies that there is a low prevalence of routine analgesia use during outpatient hysteroscopy.

Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data.

Uterine fibroids (UFs) are the most common gynaecological benign disease. Even though often asymptomatic, UFs can worsen women's health and their quality of life, causing heavy bleeding and anaemia, pelvic discomfort and reduced fertility. Surgical treatment of UFs could be limited by its invasiveness and the desire to preserve fertility. Thus, effective medical therapies for the management of this condition are needed. Common drugs used to control bleeding, such us hormonal contraceptive or levonorgestrel-releasing intrauterine system, have no effect on fibroids volume. Among other more efficient treatments, the gonadotropin-releasing hormone (GnRH) agonist or the selective progesterone-receptor modulators have a non-neutral safety profile; thus, they are used for limited periods or for cyclic treatments. Elagolix is a potent, orally bioavailable, non-peptide GnRH antagonist that acts by a competitive block of the GnRH receptor. The biological effect is a dose-dependent inhibition of gonadal axis, without a total suppression of estradiol concentrations. For this reason, even though comparative studies between elagolix and GnRH agonists have not been performed, elagolix has been associated with a better profile of adverse events. Recently, elagolix received US FDA approval for the treatment of moderate to severe pain caused by endometriosis. Several clinical trials assessed the efficacy of elagolix for the treatment of heavy bleeding caused by UFs and the definitive results of Phase III studies are expected. Available data on elagolix and UFs showed that the drug, with or without low-dose hormone add-back therapy, is able to significantly reduce menstrual blood loss, lead to amenorrhea and improve haemoglobin concentrations in the majority of participants in comparison with placebo. The safety and tolerability profile appeared generally acceptable. The concomitant use of add-back therapy can prevent bone loss due to the hypoestrogenic effect and can improve safety during elagolix treatment.

Prophylaxis of peripartum haemorrhage using recombinant factor VIIa (rfVIIa) in pregnant women with congenital factor VII deficiency: A case report and literature review.

Congenital factor VII deficiency is a rare autosomal recessive disorder associated to different haemorrhagic manifestations. Labour and delivery may cause bleeding risk in patients with this coagulation deficit, thus it is appropriate to clarify whether prophylaxis of peripartum haemorrhage is necessary. To date, there are very few cases in scientific literature which report the management of women with congenital factor VII deficiency during labour, and a consensus for prophylaxis does not exist. In this manuscript we present the management of a 35 years old woman with factor VII deficiency, treated with recombinant factor VIIa before delivery, without haemorrhagic complications either for the woman and for the infant. Therefore, we present a review of similar cases managed with a peripartum prophylaxis with recombinant factor VIIa, and discuss its usefulness and effectiveness, in view of the severity of the deficit and the doses used.

Assessing the risk of laparoscopic morcellation of occult uterine sarcomas during hysterectomy and myomectomy: Literature review and the ISGE recommendations.

OBJECTIVE: This project of the International Society for Gynecologic Endoscopy (ISGE) had the objective to review the literature and provide recommendations on the occult sarcoma risk assessment in patients who are candidates for minimally invasive gynecological surgery involving intra-abdominal electromechanical tissue morcellation. STUDY DESIGN: The ISGE Task Force for Estimation of the Risk in Endoscopic Morcellation initially defined key topics and clinical questions which may guide a comprehensive preoperative patient assessment. A literature search within the Medline/PubMed and Cochrane Database was carried out using keywords "morcellation", "uterine fibroids", "uterine sarcoma", "myomectomy" and "hysterectomy". Relevant publications (original studies, meta-analyses and previous reviews), written in English and published until May 30th, 2017, were selected and analyzed. Previously emitted statements of 12 recognized professional societies or government institutions and their supporting literature were also studied. For each topic/clinical question, the available information was graded by the level of evidence. The ISGE recommendations were established in accordance with the evidence quality. RESULTS: In the light of available information, 9 recommendations on preoperative clinical, laboratorial and imaging evaluation of the candidates for intracorporeal uterus/leiomyoma morcellation were formulated, mainly based on consensus and expert opinions. There is a lack of high-quality evidence, which does not allow the establishment of strong recommendations. CONCLUSION: Electromechanical tissue morcellation may be used in gynecological patients who are considered "low risk" upon appropriate preoperative evaluation; however, further studies and prospective data collection are greatly needed to improve sarcoma risk assessment in women with presumed uterine leiomyomas.

Pregnancy Complications After Hysteroscopic Metroplasty: A Ten-Year Case-Control Study.

INTRODUCTION: Septate uterus is one of the most common congenital uterine anomalies and it may effect female reproductive health causing different obstetric complications, in particular miscarriages and reduction of fertility. MATERIALS AND METHODS: We conducted a retrospective case-control (1:4) comparative study (Canadian Task Force Classification II-2) with the purpose to evaluate pregnancy complications (abnormal fetal presentations, preterm deliveries, and caesarean sections) and reproductive outcome after hysteroscopic metroplasty. We studied retrospectively two groups: 62 women that delivered after metroplasty (group A); and a control group of 248 women with no history of hysteroscopic metroplasty that delivered in the same period in our hospital (group B). RESULTS: The rate of abnormal fetal presentations was significantly higher in study group A versus control group B (22.58% [14/62] vs. 4.03% [10/248], p<0.0001). Caesarean section rate was significantly higher in group A versus group B (66.12% [41/62] vs. 35.08% [87/248], p<0.0001), and preterm deliveries rate was significantly higher in group A versus group B (14.51% [9/62] vs. 6.45% [16/248], p= 0.037). Furthermore, in group A, we observed a significant reduction of the abortion rate and an increase in the total number of live births after metroplasty. CONCLUSIONS: In our series of cases, we have observed a high rate of some pregnancy complications after metroplasty compared to the general population, such as preterm deliveries and fetal malpresentations with a higher rate of caesarean sections. Hysteroscopic metroplasty has been proven to improve the overall reproductive outcome by reducing miscarriage rate and increasing live birth rate. In our opinion, benefits obtained after metroplasty must be considered greater than the adverse pregnancy outcomes observed with our series.

Detection of benign intracavitary lesions in postmenopausal women with abnormal uterine bleeding: a prospective comparative study on outpatient hysteroscopy and blind biopsy.

STUDY OBJECTIVE: To evaluate the specificity of blind biopsy in detecting benign intracavitary lesions as causes of postmenopausal bleeding in comparison with directed biopsy via hysteroscopy. DESIGN: Prospective trial without randomization (Canadian Task Force classification II-1). SETTING: University hospital. PATIENTS: Three hundred nineteen postmenopausal women with abnormal uterine bleeding. INTERVENTIONS: All patients underwent both blind biopsy (Novak's curette) and directed biopsy via hysteroscopy (after at least a week). All patients with benign intracavitary lesions underwent operative hysteroscopy to enable the removal of polyps and intracavitary myomas or endometrial resection if required. All patients with pathologic reports of complex hyperplasia and atypical hyperplasia (20 patients) underwent vaginal hysterectomy with bilateral adnexectomy. All patients with histology reports of endometrial carcinoma (15 patients) underwent abdominal hysterectomy, bilateral adnexectomy, and pelvic lymphadenectomy. Histopathologic findings from endometrial specimens obtained after operative hysteroscopy or uterine specimens obtained after hysterectomy were used as a reference test to establish the prevalence of disease. MEASUREMENTS AND MAIN RESULTS: The sensitivity, specificity, accuracy, and positive and negative predictive values of blind biopsy and hysteroscopy were assessed to distinguish benign intracavitary formations such as polyps, submucous myomas, and endometrial hyperplasia in postmenopausal patients with abnormal uterine bleeding. The level of agreement was evaluated by use of the coefficient of concordance kappa. Blind biopsy showed a sensitivity of 11% and a specificity of 93%, with an accuracy of 59% in detecting endometrial polyps, a sensitivity and specificity of 13% and 100%, respectively, with an accuracy of 98% for submucous myomas, and values of 25%, 92%, and 80%, respectively, in diagnosing hyperplasia. On the other hand, hysteroscopy demonstrated a sensitivity of 100% and a specificity of 97%, with an accuracy of 91% in diagnosing endometrial polyps, a sensitivity and specificity of 100% and 98%, respectively, with an accuracy of 99% for submucous myomas. The coefficient of concordance kappa (95% CI) was 0.12 for blind biopsy and 0.82 for hysteroscopy, corresponding, respectively, to slight concordance and almost perfect agreement with final pathologic diagnosis. CONCLUSIONS: Blind biopsy (Novak's curette) demonstrates very low sensitivity and accuracy in the diagnosis of benign focal intracavitary lesions. Hysteroscopy is confirmed as the gold standard in the assessment of abnormal uterine bleeding in menopause, permitting the elimination of the false-negative results of blind biopsy through direct visualization of the uterine cavity and the performance of targeted biopsy in case of doubt.