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1.
Eur J Obstet Gynecol Reprod Biol ; 297: 254-259, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38701545

ABSTRACT

Ectopic pregnancy (EP) is a pregnancy where the growing blastocyst implants outside the endometrial cavity. EP account approximately for 0.5-1% of all pregnancies, and extrauterine implant is the leading cause of woman mortality in the first trimester of gestation. Non-tubal pregnancies (NTP) account for less than 5% of all EP. NTP are accompanied by a 7-8 times higher risk of maternal mortality when compared to tubal pregnancies, and their treatment might sometimes be very challenging. Subserosal pregnancy (SP) has been defined as rare variant of intramural pregnancy, where a portion of the gestational sac was surrounded only by the serosa of the uterus. Whereas the treatment of the ectopic pregnancies is crucial for patients' lives and for adequate fertility sparing and considering the need for surgical treatment in many cases, an early diagnosis is important; thus we believe it g might be useful to define some criteria to guide subserosal pregnancy identification, and to distinguish it from other types of non-tubal ectopic pregnancy. A systematic review on Pubmed, Scopus, Web of Science and Google Scholar was performed. Case reports, randomized controlled trials, prospective controlled studies, prospective cohort studies, retrospective studies, and case series were considered eligible. In all databases mentioned were considered manuscripts published from 1990 up to March 2023. Only four articles were eligible for inclusion in this review. All patients underwent to surgical management in laparoscopy. The main risk factors for this type of ectopic pregnancy were previous uterine surgery with opening of the endometrial cavity and assisted reproductive techniques procedures. Considering our results, we propose new classification and diagnostic criteria for subserosal pregnancy, to distinguish it from other types of non-tubal ectopic pregnancies with the aim to preserve fertility following the most correct management.


Subject(s)
Pregnancy, Ectopic , Humans , Female , Pregnancy , Pregnancy, Ectopic/diagnosis , Pregnancy, Ectopic/classification , Pregnancy, Ectopic/surgery
2.
BMC Womens Health ; 24(1): 12, 2024 01 03.
Article in English | MEDLINE | ID: mdl-38172805

ABSTRACT

BACKGROUND: The primary aim of this study was to compare the quality of life between women with obstetric anal sphincter injury (OASI) and women with intact perineum or minor vaginal tears following their first vaginal birth through a validated urogynaecological questionnaire. As a secondary aim, we wanted to identify the specific symptoms for pelvic floor dysfunction after a vaginal birth. METHODS: One hundred thirty-three cases (III- and IV-degree vaginal tears) and 133 controls (intact perineum or I- and II-degree vaginal tear) were asked to fill the PFDI-20 condition-specific and quality of life survey at three and 12 months after vaginal delivery. The survey evaluates pelvic floor dysfunction symptoms through three subsections: the Pelvic Organ Prolapse Distress Inventory (POPDI), the Colorectal-Anal Distress Inventory (CRADI), and Urinary Distress Inventory, (UDI). The scoring system ranges from 0 (no distress) to 100 (maximum distress) for each subsection, subsequently summed up to obtain the summary score (0 to 300). The patients recruited were asked to complete the survey at 3- and 12-months follow-up visit. Accordingly, data collection started. Categorical variables were subjected to Chi-square test or Fisher's Exact test. Quantitative variables were compared through Student's t-test or Mann-Whitney test. RESULTS: All surveys have shown statistically significant differences when comparing the cases to the control group. Consequently, PFDI-20 has shown a strong correlation between III- and IV-grade lacerations and pelvic floor dysfunction persistence at 12 months after delivery. Intestinal symptoms were the most reported disturbances among women with previous OASI. CONCLUSIONS: Major vaginal tears have demonstrated to have a strong impact on women's quality of life up to a follow-up of 12 months. The use of PFDI-20 questionnaire is a useful and valid tool in the diagnosis and follow-up of genital prolapse, fecal and urinary incontinence in primiparous women with a history of OASI. Thus, its application in clinical practice can help offering the most adequate rehabilitative treatment.


Subject(s)
Fecal Incontinence , Lacerations , Pelvic Floor , Vaginal Diseases , Female , Humans , Pregnancy , Case-Control Studies , Fecal Incontinence/etiology , Pelvic Floor/pathology , Quality of Life , Surveys and Questionnaires
3.
Cancers (Basel) ; 15(14)2023 Jul 19.
Article in English | MEDLINE | ID: mdl-37509340

ABSTRACT

The female genital tract can be involved as a secondary manifestation of disseminated lymphomas or leukaemia but can rarely be the primary site of so-called extranodal lymphomas. Primary lymphomas of the female genital tract can affect the uterine corpus, uterine cervix, vulva, vagina, or adnexa. Only about 0.008% of all cervical tumours are primary malignant lymphomas. The most common clinical presentation of primary cervical lymphomas is a history of prolonged minor abnormal uterine bleeding, while unstoppable bleeding at presentation is rarely reported in the literature. "B" symptoms related to nodal lymphomas are usually absent. Since vaginal bleeding is a nonspecific symptom, the first diagnostic hypothesis is usually of one of the more common female genital conditions such as cervical or endometrial carcinoma or sarcoma, fibroids, adenomyosis, or endometriosis. Cervical cytology is usually negative. Preoperative diagnosis requires deep cervical biopsy. No guidelines regarding optimal treatment exists; radiotherapy, chemotherapy, and surgery are used in different combinations. Conservative treatment with the combination of surgery and chemotherapy or surgery and radiotherapy has been reported in a few cases with apparent success. With this review, we aim to understand what the best therapeutic approaches for this rare pathology in young and elderly women are. Moreover, we find favorable pregnancy outcome in patients treated with a fertility sparing approach.

5.
BMC Womens Health ; 22(1): 425, 2022 10 27.
Article in English | MEDLINE | ID: mdl-36303205

ABSTRACT

BACKGROUND: Intrauterine devices (IUDs) are commonly used as contraceptives worldwide. However, pregnancies in patients carrying this kind of device may occur. IUD removal when the woman wishes to continue their pregnancy may be very challenging. Only 9 manuscripts in literature reported such similar procedure. CASE PRESENTATION: We report the case of an hysteroscopic removal of IUD in a young woman at 6 weeks of gestation. DISCUSSION: The case reported highlights safety and efficacy of operative hysteroscopy as a method of IUD removal in early pregnancy, although other different methods have been reported in literature. In our opinion, maintaining a low infusion pressure during the procedure may help avoiding potential gestational sac damage and IUD displacement for better grasping.


Subject(s)
Intrauterine Devices , Pregnancy , Female , Humans , Hysteroscopy/methods
6.
J Clin Med ; 11(11)2022 Jun 06.
Article in English | MEDLINE | ID: mdl-35683613

ABSTRACT

The etonogestrel (ENG) implant is among the most effective reversible contraceptives. It can be a good option for patients with different chronic diseases due to no clinically significant effects on lipid metabolism or liver function. Some limitations in the use of this type of device are represented by social and psychiatric disorders, where the easy accessibility of the device becomes a negative feature. In these patients several cases of self-removal or damage to the device have been reported. We report the successful insertion of the Nexplanon® device into the scapular region in a young woman with a chronic psychiatric disorder. To verify the presence in the literature of other possible implantation sites, we performed a systematic review of the literature on Pubmed, Google scholar and Scopus from 2000 to 2021 using different combinations of the following terms: (Nexplanon), (contraceptive implant), (insertion). Two manuscripts with three cases were detected. Nexplanon® was implanted in the upper back. In all cases, there were no complications during the insertions and the follow up demonstrated no side effects with contraceptive efficacy. Our report and review is a further confirmation that the scapular region can become a valid insertion site, maintaining good efficacy and safety of the subcutaneous device.

7.
J Minim Invasive Gynecol ; 29(3): 345-354.e1, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34600146

ABSTRACT

OBJECTIVE: Many therapies have been proposed for cervical pregnancy (CP) treatment; however, there is no consensus on the best practice to adopt, mainly owing to the rarity of this condition and the lack of randomized controlled trials. Therefore, there are no clinical practice guidelines for the management of this patient set. We presented an English literature review about the hysteroscopic management of CP. DATA SOURCES: The literature review was performed according to the Preferred Reporting Items for Scoping Reviews. The search strategy aimed at identifying cases from the first patients tracked down to those diagnosed in May of 2021. We searched in PubMed, Scopus, Google Scholar, and MEDLINE databases. Mesh terms used included "Cervical Pregnancy," "Hysteroscopy," "Ectopic pregnancy," and "Resectoscopy." METHOD OF STUDY SELECTION: Case reports of randomized controlled trials, prospective controlled studies, prospective cohort studies, retrospective studies, case series, and case reports were considered eligible. Review, Letters to the Editor, and abstracts accepted at conferences were ruled out. TABULATION, INTEGRATION, AND RESULTS: We found a total of 3572 articles in all analyzed databases. A total of 2480 articles viewed were duplicated and therefore ruled out. After screening and excluding nonpertinent articles, 109 were assessed for eligibility, and 19 were included in the analysis. All articles were single case reports, small case series with no criteria selection, randomization, or study planning. We classified them as follows: cases treated with 10 mm resectoscope, with or without pretreatments of previous CP hysteroscopic approach, and cases resolved with 5 mm hysteroscopy, with or without pretreatments of previous CP hysteroscopic approach. CONCLUSION: The hysteroscopic method represents a feasible and safe approach to the CP treatment, although there are still some aspects to be clarified, such as the pretreatment need and the instruments' type and sizes based on the beta-subunit of human chorionic gonadotropin, pregnancy age, and dimension.


Subject(s)
Pregnancy, Ectopic , Female , Humans , Hysteroscopy/methods , Pregnancy , Pregnancy, Ectopic/therapy , Prospective Studies , Retrospective Studies
8.
Front Surg ; 8: 741311, 2021.
Article in English | MEDLINE | ID: mdl-34778360

ABSTRACT

Background: Spondylodiscitis can be a rare complication of gynecological surgery, typically of procedures involving the sacrum and the sacrospinous ligament. This report presents a case of spondylodiscitis arising after a laparoscopic sacrocolpopexy with a mesh. We also review the literature finding 52 cases of spondylodiscitis following sacrocolpopexy and (or) rectopexy with or without a mesh. Methods: We performed a comprehensive search from the electronic databases MEDLINE (Pubmed), Scopus, Web of Science, Embase, CINAHL, and Google Scholar from 1990 to February 2021 in order to identify case reports or case series reporting on spondylodiscitis after rectopexy or sacrocolpopexy. Results: We identified 52 total postoperative spondylodiscitis. We examined the mean age of patients, the surgical history, the time from initial surgery to spondylodiscitis, the presenting symptoms, the diagnostic tools, the medical and surgical treatment, the type of mesh used, the surgical access, and the possible causes of spondylodiscitis. Conclusions: Diagnosis of spondylodiscitis may be challenging. From our review emerges that recurrent pelvic pain and lumbosciatalgia may be signals of lumbar spondylodiscitis. Magnetic resonance is the gold standard examination for spondylodiscitis. Surgical practice needs to be improved further in order to establish the best procedure to minimize the incidence of this complication. Awareness of symptoms, timely diagnosis, and treatment are fundamental to prevent irreversible complications.

9.
Article in English | MEDLINE | ID: mdl-34574671

ABSTRACT

OBJECTIVE: to evaluate risk factors, causes, management and surgical therapy of postcoital vaginal perforation and evisceration in women with no prior pelvic surgery. DATA SOURCES: We used MEDLINE (PubMed), Scopus, Embase and Web of Science for our research. Our review includes all reports from 1980 to November 2020. The research strategy adopted included different combinations of the following terms: (intercourse) AND (coitus) AND (vaginal perforation). METHODS OF STUDY SELECTION: we report a case of vaginal evisceration after consensual intercourse in a young and healthy woman. In addition, we performed a systematic review of vaginal perforations with or without evisceration in women without prior surgery or any other predisposing disease. All studies identified were listed by citation, title, authors and abstract. Duplicates were identified by an independent manual screening, performed by one researcher and then removed. For the eligibility process, two authors independently screened the title and abstracts of all non-duplicated papers and excluded those not pertinent to the topic. TABULATION, INTEGRATION AND RESULTS: We have followed the PRISMA guidelines. Five manuscripts were detected through the references of the works that had been identified with the research on MEDLINE (PubMed), Scopus, Embase and Web of Science. We found 16 cases between 1980 and 2020. The young age and the virginal status represent the principal risk factors and all the lacerations occurred in the posterior vaginal fornix. The most common surgical technique was the laparotomic approach and, in the remaining cases, the laparoscopic and vaginal route was performed. CONCLUSIONS: Post-coital vaginal perforation and evisceration in women with no prior pelvic surgery is a rare condition in the clinical practice and, when it is associated with evisceration it is a surgical emergency. Usually, these injuries are not life-threatening conditions but, a delay in diagnosis, can lead to severe complications. In consideration of the high heterogeneity of the data in the literature, it is essential to define a diagnostic-therapeutic management for the patients with vaginal perforation. With our review, we try to identify the associated risk factors, the best and fastest diagnosis, and the best surgical approach. We believe that a combined vaginal and laparoscopic approach can be the best surgical treatment, useful to diagnose injuries of the abdominal organs and to improve postoperative outcome.


Subject(s)
Laparoscopy , Vaginal Diseases , Coitus , Female , Humans , Rupture/surgery , Vaginal Diseases/surgery
10.
Article in English | MEDLINE | ID: mdl-34574706

ABSTRACT

Interstitial pregnancy is defined as the presence of a gestational sac in the most proximal section of the fallopian tube. Management of interstitial pregnancy remains a debated topic. Depending on hemodynamic stability, size of pregnancy, depth of surrounding myometrium, and desires for future fertility, interstitial pregnancy can be managed medically or surgically. We reviewed the literature in December 2020 using keywords "interstitial pregnancy", "medical treatment", "methotrexate", and "mifepristone". Articles published from January 1991 until 2020 were obtained from databases EMBASE, SCOPUS, and PUBMED. We describe the case of a patient with an interstitial pregnancy that was managed with a total medical approach in August 2020 at Burlo Garofolo Hospital. The patient was asymptomatic and hemodynamically stable, with a high level of serum ß-hCG (22,272 mUi/mL). We used the combination of methotrexate (MTX) and mifepristone. Medical therapy was effective leading to interstitial pregnancy resolution in 51 days without collateral effects for the patient. We found seven previous cases reported in the literature. Our purpose is to underline the efficacy of medical therapy with systemic multidose MTX associated with a single oral dose of mifepristone and also folinic acid when is present a viable fetus and a high serum ß-hCG level.


Subject(s)
Mifepristone , Pregnancy, Interstitial , Female , Fertility , Humans , Methotrexate/therapeutic use , Mifepristone/therapeutic use , Myometrium , Pregnancy
11.
Article in English | MEDLINE | ID: mdl-34072739

ABSTRACT

Uterine leiomyomas are a common finding in medical practice, but their frequency changes drastically when contextualized in a syndrome, as in the following case. A 50-year-old woman with a known Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome presented at our clinic with abdominal pain located in the lower quadrants and scarcely responsive to analgesic therapy. A twisted gynecological pelvic mass was diagnosed, and management for prompt resolution was adopted. Histologically the mass was described as a leiomyoma. The aim of the present study is to share our experience and to review the literature to compare different manifestation of the disease and different approach used in the various centers. The additional novelty of the paper is the immunohistochemical study we carried out on the leiomyoma that is contrasted with the current etiopathogenetic theories.


Subject(s)
46, XX Disorders of Sex Development , Congenital Abnormalities , Leiomyoma , 46, XX Disorders of Sex Development/diagnosis , Abdominal Pain , Female , Humans , Leiomyoma/diagnosis , Middle Aged , Mullerian Ducts , Rare Diseases
12.
Diagnostics (Basel) ; 10(9)2020 Aug 31.
Article in English | MEDLINE | ID: mdl-32878097

ABSTRACT

Non-tubal ectopic pregnancies (NT-EPs) are rare but potentially life-threatening conditions. The incidence ranges are between 5-8.3% of all ectopic pregnancies. For this retrospective observational study, 16 patients with NT-EP and treated from January 2014 to May 2020 were recruited. Demographic details, symptoms, Beta human chorionic gonadotrophin (ß-hCG) levels, ultrasound findings, management and treatment outcomes were presented. In hemodynamically stable patients, diagnosis was made using ultrasounds and ß-hCG levels. Laparoscopy was essential to identify and remove the ectopic pregnancy in clinical unstable patients. A radical laparoscopic approach was chosen in one case of cervical pregnancy diagnosed late in the first trimester. Medical treatment and minimally invasive procedure, alone or combined, resulted in effective strategies in asymptomatic women with an early diagnosis of NT-EP. We report cases of cervical pregnancies successfully treated by hysteroscopy alone or combined with medical treatment, the first case of scar pregnancy treated by mini-reseptoscope and curettage and the fifth case of interstitial pregnancy treated with Methotrexate and Mifepristone. In this manuscript we report a single center experience in the management of NT-EPs with the aim of outlining the importance of the early diagnosis for a minimally invasive treatment in order to reduce maternal morbidity and mortality and preserve future fertility.

13.
Medicine (Baltimore) ; 99(26): e20491, 2020 Jun 26.
Article in English | MEDLINE | ID: mdl-32590732

ABSTRACT

BACKGROUND: Atypical polypoid adenomyoma (APA) is a rare uterine tumor typically found in fertile age and associated with infertility. Among young nullipara women, conservative treatment is proposed despite the high recurrence rate and the association with endometrial cancer.Our aim was to assess the risk of recurrence with different conservative treatments in fertile ages and the prevalence of malignant or pre-malignant associated lesions to better address an adequate patient counselling when treatment modalities are discussed. METHODS: This study is a systematic review and meta-analysis of case reports and case series about APA management and follow-up. A literature search was carried from Medline and Scopus for studies published from January 1, 1980 to December 31, 2018. RESULTS: We included 46 observational studies and 296 cases in fertile women. The prevalence of APA relapse was 44% (CI.95 33-57%) and was lower in cases treated with operative hysteroscopy (22%; CI.95 11-39%) than in cases treated with blind curettage and polypectomy (38%; CI.95 15-67%). The prevalence of the concomitant or during the follow-up diagnosis of endometrial carcinoma was 16% (CI.95 9-29%). The risk of cancer development during follow-up was significantly less in cases treated with histeroscopy (10.56% new cumulative diagnosis at 5 years follow up; CI.95 0-23.7%) than blind curettage and polypectomy (35.5% new cumulative diagnosis at 5 years; CI.95 11.65-52.92%; P < .05). Medical treatment with medroxyprogesterone acetate after surgery does not reduce APA recurrence. Pregnancy was observed in 79% cases in which the desire was expressed. CONCLUSION: This review suggests that conservative treatment performed by operative hysteroscopy is the optimal choice because it lowers the risk of recurrence, improves the accuracy of concomitant carcinoma or hyperplasia diagnosis, and leaves the possibility of future pregnancies.


Subject(s)
Adenomyoma/therapy , Neoplasm Recurrence, Local/pathology , Uterine Neoplasms/therapy , Adenomyoma/pathology , Antineoplastic Agents, Hormonal/therapeutic use , Chemotherapy, Adjuvant , Conservative Treatment , Curettage , Endometrial Hyperplasia/pathology , Endometrial Neoplasms/pathology , Female , Humans , Hysteroscopy , Medroxyprogesterone Acetate/therapeutic use , Neoplasms, Multiple Primary , Pregnancy , Pregnancy Rate , Uterine Neoplasms/pathology
14.
Medicina (Kaunas) ; 56(6)2020 Jun 12.
Article in English | MEDLINE | ID: mdl-32545627

ABSTRACT

Background and objectives: Cervical pregnancy (CP) is a rare form of ectopic pregnancy (EP) in which the embryo implants and grows inside the endocervical canal. Early diagnosis is essential in order to allow conservative medical and surgical treatments. Although many treatment approaches are disponible, the most effective is still unclear. The aim of this study is to evaluate the efficacy of hysteroscopic management in early CP in order to preserve future fertility. Materials and Methods: This is a retrospective observational case series. Five patients with a diagnosis of CP, hemodynamically stables and managed conservatively between 2014 and 2019 at the Institute of Child and Maternal Health Burlo Garofolo in Trieste, Italy, were included. Four patients, with ßhCG levels >5000 mUi/mL were managed by hysteroscopy, with or without a previous systemic Methotrexate (MTX). One case with ßhCG levels <5000 mUi/mL was treated using MTX combined to Mifepristone and Misoprostol. Results: In one patient treated by hysteroscopy alone it occurred a profuse vaginal bleeding with necessity for blood transfusion. Haemorrhage was controlled by a second hysteroscopic procedure. No complications, such as vaginal bleeding, were recorded in the other cases. Serum ß-hCG levels become undetectable in a range of 15-40 days after hysteroscopic management; after medical treatment it become undetectable after 35 days. Serum ßhCG levels had a faster drop the day after hysteroscopy than post medical management. The onset of a spontaneous pregnancy at the normal implantation site occurred after five months in one case treated by hysteroscopy. Conclusions: Many therapeutic approaches are effective for CP treatment. Hysteroscopy, alone or in combination with MTX, may provide a greater effect on the descent of ßhCG, leading to a reduction of the hospitalization stay, decreasing costs and period for attempt pregnancy. Further prospective studies on larger samples are needed to define therapeutic protocols for CP management.


Subject(s)
Pregnancy, Ectopic/therapy , Abortifacient Agents, Nonsteroidal/standards , Abortifacient Agents, Nonsteroidal/therapeutic use , Adult , Female , Fertility/drug effects , Humans , Hysteroscopy/methods , Italy/epidemiology , Methotrexate/standards , Methotrexate/therapeutic use , Pregnancy , Pregnancy, Ectopic/epidemiology , Prospective Studies , Retrospective Studies , Treatment Outcome
15.
J Minim Invasive Gynecol ; 26(6): 1011-1012, 2019.
Article in English | MEDLINE | ID: mdl-30690170

ABSTRACT

STUDY OBJECTIVE: To evaluate the efficacy of total surgical treatment of ectopic cervical pregnancy [1] with a minimally invasive approach performed by hysteroscopy [2]. DESIGN: Step-by-step video demonstration of the surgical technique using 5 mm hysteroscopy followed by 10 mm resectoscopy. SETTING: A research and university hospital (IRCCS Burlo Garofolo, Trieste, Italy). PATIENTS: A 41-year-old woman with an ultrasound diagnosis of ectopic cervical pregnancy at 6 + 6 weeks of gestation with a beta human chorionic gonadotropin serum level of 55.951 mUI/mL. INTERVENTIONS: We performed a 2-step technique using 5- and 10-mm hysteroscopy (Video 1). During the first step, a 5-mm Bettocchi hysteroscope (Karl Storz, Tuttlingen, Germany) with a 5F bipolar electrode Versapoint Twizzle (Gynecare, Menlo Park, CA) was used. In this phase, the gestational sac was identified in order to confirm the diagnosis and its site of implantation. Later, the gestational sac was opened, and the pregnancy was terminated by cord section under an embryoscopic view (Fig. 1). Finally, a partial vessel coagulation was performed. Afterward, the cervix was dilated, and a resectoscopy was performed. During the second step, a 10-mm Gynecare resectoscope with the bipolar Gynecare Versapoint was used and the gestational sac with the embryo was removed; subsequently, a complete chorial villi resection was achieved. At last, a coagulation of bleeding vessels on the implantation site in order to control the hemostasis was performed (Fig. 2). MEASUREMENTS AND MAIN RESULTS: The study was approved by the institutional review board. The patient was discharged 24 hours after the procedure with an uneventful postoperative course, and the beta human chorionic gonadotropin serum level became negative in 20 days. After 40 days, the ultrasound cervical findings were regular, whereas office hysteroscopy showed the implantation site scar. After 5 months, the patient was pregnant with regular intrauterine implantation (Fig. 3). CONCLUSION: The total hysteroscopic approach with a 2-step technique offers an effective, safe, and minimally invasive surgical treatment to ectopic cervical pregnancy. Considering that our method, in contrast with the recent literature [3-5], is performed without any medical treatment, we reported for the first time an approach, that deserve more clinical data to confirm its effectiveness.


Subject(s)
Cervix Uteri/surgery , Hysteroscopy/methods , Pregnancy, Ectopic/surgery , Adult , Cervix Uteri/pathology , Cesarean Section/adverse effects , Cicatrix/pathology , Cicatrix/surgery , Female , Humans , Hysteroscopes , Hysteroscopy/instrumentation , Italy , Minimally Invasive Surgical Procedures/instrumentation , Minimally Invasive Surgical Procedures/methods , Pregnancy , Ultrasonography
16.
J Minim Invasive Gynecol ; 24(4): 640-645, 2017.
Article in English | MEDLINE | ID: mdl-28232037

ABSTRACT

STUDY OBJECTIVE: To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. DESIGN: A retrospective multicenter study (Canadian Task Force classification II2). SETTING: Seven general hospitals and 4 clinical teaching centers in Italy. PATIENTS: A total of 1968 women, mean age 39.5 years (range, 23-48 years) who underwent office hysteroscopic sterilization using the Essure insert between April 1, 2003, and December 30, 2014. INTERVENTION: The women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy). MEASUREMENTS AND MAIN RESULTS: Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up), and late complications were evaluated. Satisfactory insertion was accomplished in 97.2% of women and, in 4, perforation and 1 expulsion were detected during hysterosalpingography. Three unintended pregnancies occurred before the 3-month confirmation test. Two pregnancies were reported among women relying on the Essure inserts. Postprocedure pain was minimal and brief; in 9 women, pelvic pain became intractable, necessitating removal of the devices via laparoscopy. On telephone interviews, overall satisfaction was rated as "very satisfied" by the majority of women (97.6%), and no long-term adverse events were reported. CONCLUSION: The findings from this extended Italian survey further support the effectiveness, tolerability, and satisfaction of Essure hysteroscopic sterilization when motivated women are selected and well informed of the potential risks of the device. Moreover, the results do not demonstrate an increased incidence of complications and pregnancies associated with long-term Essure use. Patients with a known hypersensitivity to nickel may be less suitable candidates for the Essure insert.


Subject(s)
Sterilization, Reproductive , Sterilization, Tubal/methods , Adult , Fallopian Tubes/diagnostic imaging , Female , Follow-Up Studies , Humans , Hypersensitivity , Hysterosalpingography , Hysteroscopy , Italy , Laparoscopy , Middle Aged , Nickel/adverse effects , Pain/etiology , Pregnancy , Pregnancy, Unplanned , Retrospective Studies , Sterilization, Reproductive/adverse effects , Sterilization, Reproductive/instrumentation , Sterilization, Reproductive/methods , Sterilization, Tubal/adverse effects , Surveys and Questionnaires , Young Adult
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