Removal Of Myomas Research Articles

Infertility and uterine fibroids

Uterine fibroids are the most common tumors in women and their prevalence is higher in patients with infertility. At present, they are classified according to their anatomical location, as no classification system includes additional parameters such as their size or number. There is a general agreement that submucosal fibroids negatively affect fertility, when compared to women without fibroids. Intramural fibroids above a certain size (>4cm), even without cavity distortion, may also negatively influence fertility. However, the presence of subserosal myomas has little or no effect on fertility. Many possible theories have been proposed to explain how fibroids impair fertility: mechanisms involving alteration of local anatomical location, others involving functional changes of the myometrium and endometrium, and finally endocrine and paracrine molecular mechanisms. Nevertheless, any of the above mentioned mechanisms can cause reduced reproductive potential, thereby leading to impaired gamete transport, reduced ability for embryo implantation, and creation of a hostile environment. The published experience defines the best practice strategy, as not many large, well-designed, and properly powered studies are available. Myomectomy appears to have an effect in fertility improvement in certain cases. Excision of submucosal myomas seems to restore fertility with pregnancy rates after surgery similar to normal controls. Removal of intramural myomas affecting pregnancy outcome seems to be associated with higher pregnancy rates when compared to non-operated controls, although evidence is still nοt sufficient. Treatment of subserosal myomas of reasonable size is not necessary for fertility reasons. The results of endoscopic and open myomectomy are similar; thus, endoscopic treatment is the recommended approach due to its advantages in patient's postoperative course.

A Health Technology Assessment: laparoscopy versus colpoceliotomy.

The objective of this paper is the comparison between two different technologies used for the removal of a uterine myoma, a frequent benign tumor: the standard technology currently used, laparoscopy, and an innovative one, colpoceliotomy. It was considered relevant to evaluate the real and the potential effects of the two technologies implementation and, in addition, the consequences that the introduction or exclusion of the innovative technology would have for both the National Health System (NHS) and the entire community. The comparison between these two different technologies, the standard and the innovative one, was conducted using a Health Technology Assessment (HTA). In particular, in order to analyse their differences, a multi-dimensional approach was considered: effectiveness, costs and budget impact analysis data were collected, applying different instruments, such as the Activity Based Costing methodology (ABC), the Cost-Effectiveness Analysis (CEA) and the Budget Impact Analysis (BIA). Organisational, equity and social impact were also evaluated. The results showed that the introduction of colpoceliotomy would provide significant economic savings to the Regional and National Health Service; in particular, a saving of € 453.27 for each surgical procedure. The introduction of the innovative technology, colpoceliotomy, could be considered a valuable tool; one offering many advantages related to less invasiveness and a shorter surgical procedure than the standard technology currently used (laparoscopy).

How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study

A clinical trial is a prospective study designed to establish the safety and efficacy of investigational devices in humans, in accordance with the strict guidelines of the Food and Drug Administration (FDA; USA) or European Medicines Agency (EMA; Europe). Before a clinical first-in-human study is initiated, preclinical studies of the investigational product are mandatory, and the results should be sufficient to indicate that the investigational device is acceptably safe for the proposed evaluation in human subjects. The present paper describes an experience of clinical trials, highlighting ways of avoiding possible complications in clinical first-in-human studies. For a better approach to our aim, we exemplified a prospective, randomized, single-blind study, ADBEE. The primary objective was to assess the safety of the ADBLOCK system when used as an adjunct to laparoscopic primary removal of myomas in women wishing to improve pregnancy outcomes.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas.

PurposeTo evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure® device.Patients and methodsThis was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized.ResultsA total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events.ConclusionThe MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.

Three-month treatment with triptorelin, letrozole and ulipristal acetate before hysteroscopic resection of uterine myomas: prospective comparative pilot study

ObjectiveTo compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas. Study designSingle center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75mg every 28 days; group T; n=20), letrozole (2.5mg/day; group L; n=11) or ulipristal acetate (5mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas. ResultsAll medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005). ConclusionsPreoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas.

Duration of Sick Leave, Patient's Postoperative Satisfaction and Impairment of Daily Living after Open Abdominal Myoma Enucleation in Dependence on Myoma Size.

Purpose: What is the average duration of sick leave and the postoperative impairment to daily living in dependence on the size of the removed myoma? Does patient satisfaction depend on the size of the removed myoma? Is there a difference in the rate of improvement of symptoms depending on the size of the myoma? Patient Collective: This is a retrospective survey of the data of 377 consecutive female patients treated for symptomatic uterus myomatosus by open abdominal myoma enucleation between 2/2002 and 12/2009; the number of removed myomas, myoma size and localisation, myoma-associated complaints, length of sick leave, postoperative impairments of daily living and scar length were assessed. Results: The response rate amounted to 61 % (230/377 patients). The average sick leave of patients with a myoma diameter ≥ 10 cm was 1.5 days shorter than that for patients with myomas < 10 cm. Depending on the symptoms between 7 and 75 % of the patients reported an improvement of their complaints. For those patients with myomas > 10 cm the proportion with an improvement in symptoms was smaller than that for the patients with smaller myomas - exception "feeling of pressure in the bladder". Conclusions: Even for relatively large myomas, the quality of life is not impaired more strongly or for longer periods than that after removal of smaller myomas. Activities of daily life are impaired for about 4 weeks.

Is Cold Loop Hysteroscopic Myomectomy a Safe and Effective Technique for the Treatment of Submucous Myomas With Intramural Development? A Series of 1434 Surgical Procedures.

To assess the safety and efficacy of cold loop hysteroscopic myomectomy in a large series of cases. Retrospective study (Canadian Task Force Classification III). Arbor Vitae Center for Endoscopic Gynecology, Rome, Italy. A total of 1215 patients with 1 or more G1-G2 submucous myomas. Cold loop hysteroscopic myomectomy. A total of 1690 myomas were removed. A minimum of 1 to a maximum of 5 fibroids for each surgical procedure were totally removed. Out of 1215 patients, 1017 (83.7%) were treated with a single surgical procedure. Twelve intraoperative complications occurred (0.84%). No cases of uterine perforation with the thermal loop or clinical intravasation syndrome were reported. Cold loop hysteroscopic myomectomy seems to represent a safe and effective procedure for the removal of submucous myomas with intramural development, while at the same time respecting the anatomic and functional integrity of the myometrium. The use of a cold loop in resectoscopic myomectomy is associated with a low rate of minor intraoperative complications and an absence of major complications. This could be of primary relevance with a view to fertility and future pregnancies.

Fertility and Pregnancy Outcome after Myoma Enucleation by Minilaparotomy under Microsurgical Conditions in Pronounced Uterus Myomatosus.

Introduction: Besides the typical complaints and symptoms, myomas can cause sterility, infertility and complications during pregnancy. Laparoscopic interventions reach their limits with regard to organ preservation and the simultaneous desire to have children in the removal of multiple and larger intramural myoma nodes. The aim of this study is to examine fertility status and pregnancy outcome after myoma removal by minilaparotomy (skin incision maximal 8 cm) in women with pronounced uterus myomatosus. Materials and Methods: This retrospective study makes use of the data from 160 patients with an average age of 34.6 years. Factors analysed include number, size and localisation of the myomas, complaints due to the myoma, pre- and postoperative gravidity, mode of delivery, and complications of birth. Results: Indications for organ-sparing myoma enucleation were the desire to have children (72.5 %), bleeding disorders (60 %) and pressure discomfort (36.5 %). On average 4.95 (SD ± 0.41), maximally 46 myomas were removed. The largest myoma had a diameter of 6.64 cm (SD ± 2.74). 82.5 % of the patients had transmural myomas, in 17.5 % the uterine cavity was inadvertently opened. On average the operating time was 163 minutes (SD ± 45.47), the blood loss 1.59 g/dL (SD ± 0.955). 60.3 % of the patients with the desire to have children became pregnant postoperatively. 75.3 % of the pregnancies were on average carried through to the 38th week (28.4 % vaginal deliveries, 71.6 % Caesarean sections). In the postoperative period there was one case of uterine rupture in the vicinity of a previous scar. Discussion: By means of the microsurgical "mini-laparotomy" even extensive myomatous uterine changes can, in the majority of cases, be operated in an organ-sparing manner with retention of the ability to conceive and to carry a pregnancy through to maturity of the infant. The risk for a postoperative uterine rupture in a subsequent pregnancy and during delivery is minimal.

Офисная гистероскопия в диагностике и лечении внутриматочной патологии

The main method of endometrial pathology diagnosis is outpatient ultrasonography (US) of the pelvic organs. Despite its high accuracy and specificity, false-positive or false-negative results, according to different authors, can occur in 20-30% of cases. To clarify the status of the cervix and uterus, as well as provide treatment (see-and-treat principle) in the outpatient setting it becomes possible with using office hysteroscopy. Carrying out such surgical procedures as an endometrial biopsy, separation walls and uterine adhesions, removal of polyps and submucous myomas, sterilization and removal of foreign bodies of the uterus is also possible. Each of these manipulations requires the use of standardized methods, allowing to reduce the operation time and improve the safety of the intervention. To reduce the risk of complications, it is important to observe a number of technical specifications relating to the situation of the patient, the characteristics of dilation of the uterus, and the rules for the use of electrosurgical equipment. Should these conditions be met, about 60% of all patients with endometrial pathology can be treated as outpatients.

Office Hysteroscopic Laser Enucleation of Submucous Myomas without Mass Extraction: A Case Series Study.

Background and Objectives. A new two-step hysteroscopic myomectomy carried out in the office setting and without anesthesia was feasible for the excision of submucous myomas. The objective of this study was to assess whether removal of submucous myomas from the uterine cavity after hysteroscopic laser enucleation is necessary. Methods. Between June 2009 and April 2013, all outpatients with symptomatic myomatosis (bleeding, pelvic pain, and infertility) assessed ultrasonographically were eligible to participate in a prospective study. All patients underwent office hysteroscopic enucleation of submucous myomas. Enucleated myomas were left in the uterine cavity. Neither anesthesia nor antibiotic prophylaxis was used. Results. Sixty-one women (mean age: 47.3 years) were included. Regardless of hysteroscopic localization and grading, all myomas were enucleated. The mean (standard deviation, SD) diameter of the myoma as measured by the ultrasound scan was 22.6 (8.5) mm. In 29 cases (47.5%), the diameter of the resected myoma was >20 mm and in 10 cases (16.4%) >30 mm. After a mean follow-up of 68.2 (16.5) days, none of the patients showed a residual myoma inside the uterine cavity. Conclusions. The present results indicate that leaving laser-enucleated submucous myoma in the uterine cavity is a feasible and safe therapeutic option.

Pros and Cons of Cesarean Myomectomy: A Retrospective Study

Background: Myoma incidence during pregnancy is estimated to be 0.5%–5%, with 1 in 10 of these women having myoma-related complications. In recent years, the percentage of these ocurrences appears to be higher, as more myomas have been noted in older pregnant women. Myomectomy during cesarean section is controversial because of the risks of uncontrollable hemorrhage and obliteration of the fibromyoma cavity. Yet, the medical literature has reported an increasing rate of myomectomies during cesarean sections during the past decade. Objective: The aim of this study was to investigate if removal of myomas during cesarean section aggravates the postoperative period. Materials and Methods: During 2006–2013, the outcomes of myomectomy during cesarean section were evaluated retrospectively. The study included 130 patients undergoing cesarean myomectomy and 346 women with known myomas undergoing only cesarean section. The patients' demographic characteristics, gestational age at delivery, myoma characteristics, mean change in hemoglobin values (g/dL), postoperative complications, surgery duration, and days of hospital stay were all recorded and analyzed. Results: There was no statistically significant difference in the patients' characteristics between the groups. The mean change in hemoglobin values was similar in the groups, and no patients needed blood transfusion. Frequency of postoperative fever and other postoperative complications were the same in the groups. Myomectomy added a mean time of 13 minutes to the operative procedure and increased the length of hospital stay by an average of 0.7 days, which were considered to be statistically significant differences. No cesarean hysterectomy or other repeated surgery was required for the patients in the myomectomy group. The postdischarge period was uncomplicated for all of the patients. Conclusions: Cesarean myomectomy is recommended in selected cases and should be done by experienced surgeons. (J GYNECOL SURG 30:338)

Twelve-Month Outcomes for Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas in an Office or Ambulatory Surgical Center

Study ObjectiveTo examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. DesignRandomized, prospective, comparative setting clinical trial (Canadian Task Force classification II-2). SettingNine outpatient obstetrics and gynecology practices and hospitals in the United States. PatientsWomen 18 to 55 years of age with polyps and/or type 0 or I myomas ≥1.5 and ≤3.0 cm. InterventionsTreatment of polyps and fibroids with the MyoSure device. Measurements and Main ResultsA total of 118 lesions (76 polyps, 42 myomas) were removed. Among the 118 pathologies removed, 53 were removed in an office setting (28 myomas, 25 polyps), and 55 were removed in an ambulatory surgical center (ASC) setting (14 myomas, 41 polyps). The mean percentage of pathology removed was 95.9 ± 6.8% for fibroids and 99.9 ± 0.7% for polyps. Symptom severity as measured by the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scale improved significantly (p < .01) between baseline (mean score of 67.5 ± 15.4) and 12 months postprocedure (mean score of 22.3 ± 22.6). The Health-Related Quality of Life (HRQOL) scale also improved significantly (p < .01) between baseline (mean score 38.7 ± 23.3) and 12 months postprocedure (mean score of 83.9 ± 24.4). Both the office and ASC groups demonstrated a statistically significant (p < .01) improvement in UFS-QOL and HRQOL. ConclusionFor women with intrauterine polyps and/or myomas who experienced abnormal uterine bleeding, hysteroscopic morcellation with the MyoSure device provided significant, durable health-related, quality-of-life improvements up to 12 months postprocedure. These findings were the same for patients treated in both an office-based setting and ASCs.

Single Port Repair of Defect at Isthmic Area during Single Port Laparoscopic Huge Myomectomy

This video presents a case of 33 year old single woman who underwent a single port repair of defect at cervical isthmic area during single port laparoscopic huge myomectomy. Pelvis MRI shows huge subserosal myoma which located at posterior part of isthmus, and boundary between myoma and isthmic area is unclear. 3cm incision was made at umbilicus, and we found the huge retroperitoneal myoma. Because there was no definite demarcation from myoma, a part of posterior isthmic area was removed. After removal of myoma, we found segmental defect of isthmic area.

Hystéroscopie opératoire pour fibrome : morcellement versus résection à l’anse bipolaire

To evaluate the results associated with hysteroscopic morcellation for submucous myomas removal, and to compare with those observed associated with bipolar loop resection. A retrospective comparative study was conducted in two universitary centers from January 2012 to December 2013. A total of 83 patients, who presented with submucous myomas type 0,1 and 2, were included. The number of myomas type 0,1 was 36 (71 %) and 15 (29 %) myomas type 2 in morcellation group versus 44 (59 %) myomas type 0,1 and 31 (41 %) type 2 in electrosurgical resection group (P=0.17). Hysteroscopic morcellation or electrosurgical resection with bipolar loop for removal submucous myomas were performed. Thirty-four patients underwent hysteroscopic morcellation using MyoSure(®), and 49 had hysteroscopic resection using Versapoint-24F(®) bipolar loop. The mean operative duration was 30minutes in morcellation group, compared to 31minutes in bipolar resection group (P=0.98). Complete myoma removal was achieved in 22 (64 %) patients in morcellation group, and in 34 (69 %) in bipolar resection group (P=0.65). There were no difference in the occuring of adverse events between the two. The prevalence of postoperative intra-uterine adherence was 10 % in morcellation group and 13.8 % in bipolar resection group (P=0.69). In the current short comparative series, hysteroscopic morcellation and bipolar loop resection were associated with comparable results for removal of submucous myomas.

Interventions to reduce haemorrhage during myomectomy for fibroids.

Benign smooth muscle tumours of the uterus, known as fibroids or myomas, are often symptomless. However, about one-third of women with fibroids will present with symptoms that are severe enough to warrant treatment. The standard treatment of symptomatic fibroids is hysterectomy (that is surgical removal of the uterus) for women who have completed childbearing, and myomectomy for women who desire future childbearing or simply want to preserve their uterus. Myomectomy, the surgical removal of myomas, can be associated with life-threatening bleeding. Excessive bleeding can necessitate emergency blood transfusion. Knowledge of the effectiveness of the interventions to reduce bleeding during myomectomy is essential to enable evidence-based clinical decisions. This is an update of the review published in The Cochrane Library (2011, Issue 11). To assess the effectiveness, safety, tolerability and costs of interventions to reduce blood loss during myomectomy. In June 2014, we conducted electronic searches in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO, and trial registers for ongoing and registered trials. We selected randomised controlled trials (RCTs) that compared potential interventions to reduce blood loss during myomectomy to placebo or no treatment. The two authors independently selected RCTs for inclusion, assessed the risk of bias and extracted data from the included RCTs. The primary review outcomes were blood loss and need for blood transfusion. We expressed study results as mean differences (MD) for continuous data and odds ratios for dichotomous data, with 95% confidence intervals (CI). We assessed the quality of evidence using GRADE methods. Eighteen RCTs with 1250 participants met our inclusion criteria. The studies were conducted in hospital settings in low, middle and high income countries.Blood lossWe found significant reductions in blood loss with the following interventions: vaginal misoprostol (2 RCTs, 89 women: MD -97.88 ml, 95% CI -125.52 to -70.24; I(2) = 43%; moderate-quality evidence); intramyometrial vasopressin (3 RCTs, 128 women: MD -245.87 ml, 95% CI -434.58 to -57.16; I(2) = 98%; moderate-quality evidence); intramyometrial bupivacaine plus epinephrine (1 RCT, 60 women: MD -68.60 ml, 95% CI -93.69 to -43.51; low-quality evidence); intravenous tranexamic acid (1 RCT, 100 women: MD -243 ml, 95% CI -460.02 to -25.98; low-quality evidence); gelatin-thrombin matrix (1 RCT, 50 women: MD -545.00 ml, 95% CI -593.26 to -496.74; low-quality evidence); intravenous ascorbic acid (1 RCT, 102 women: MD -411.46 ml, 95% CI -502.58 to -320.34; low-quality evidence); vaginal dinoprostone (1 RCT, 108 women: MD -131.60 ml, 95% CI -253.42 to -9.78; low-quality evidence); loop ligation of the myoma pseudocapsule (1 RCT, 70 women: MD -305.01 ml, 95% CI -354.83 to -255.19; low-quality evidence); and a fibrin sealant patch (1 RCT, 70 women: MD -26.50 ml, 95% CI -44.47 to -8.53; low-quality evidence). We found evidence of significant reductions in blood loss with a polyglactin suture (1 RCT, 28 women: MD -1870.0 ml, 95% CI -2547.16 to 1192.84) or a Foley catheter (1 RCT, 93 women: MD -240.70 ml, 95% CI -359.61 to -121.79) tied around the cervix. However, pooling data from these peri-cervical tourniquet RCTs revealed significant heterogeneity of the effects (2 RCTs, 121 women: MD (random) -1019.85 ml, 95% CI -2615.02 to 575.32; I(2) = 95%; low-quality evidence). There was no good evidence of an effect on blood loss with oxytocin, morcellation or clipping of the uterine artery.Need for blood transfusion We found significant reductions in the need for blood transfusion with vasopressin (2 RCTs, 90 women: OR 0.15, 95% CI 0.03 to 0.74; I(2) = 0%; moderate-quality evidence); peri-cervical tourniquet (2 RCTs, 121 women: OR 0.09, 95% CI 0.01 to 0.84; I(2) = 69%; low-quality evidence); gelatin-thrombin matrix (1 RCT, 100 women: OR 0.01, 95% CI 0.00 to 0.10; low-quality evidence) and dinoprostone (1 RCT, 108 women: OR 0.17, 95% CI 0.04 to 0.81; low-quality evidence), but no evidence of effect on the need for blood transfusion with misoprostol, oxytocin, tranexamic acid, ascorbic acid, loop ligation of the myoma pseudocapsule and a fibrin sealant patch.There were insufficient data on the adverse effects and costs of the different interventions. At present there is moderate-quality evidence that misoprostol may reduce bleeding during myomectomy, and low-quality evidence that bupivacaine plus epinephrine, tranexamic acid, gelatin-thrombin matrix, a peri-cervical tourniquet, ascorbic acid, dinoprostone, loop ligation and a fibrin sealant patch may reduce bleeding during myomectomy. There is no evidence that oxytocin, morcellation and temporary clipping of the uterine artery reduce blood loss. Further well designed studies are required to establish the effectiveness, safety and costs of different interventions for reducing blood loss during myomectomy.

Hysteroscopic Morcellation: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database

Study ObjectiveTo investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DesignSystematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SettingN/A. PatientsWomen undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. InterventionsThe MAUDE database was searched for the key words “Hysteroscope,” “Hysteroscopic reciprocating morcellator,” “Interlace,” “MyoSure,” “Smith & Nephew,” and “TRUCLEAR,” to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. Measurements and Main ResultsFrom 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. ConclusionsThe suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.

Limits and complications of laparoscopic myomectomy: which are the best predictors? A large cohort single-center experience.

To determine whether a correlation exists between size, location, type of myomas and perioperative outcomes. This is a observational study in women undergone to laparoscopic myomectomy (LM) because of single symptomatic myoma >4 cm in diameter. We collected data about general features, surgical outcomes, intraoperative/postoperative complications and time to return to normal activity. A total of 444 patients (mean age 36.7 ± 6.4 years) resulted eligible for the study. Myomas sized between 8 and 12 cm were linked to an increased amount of blood loss (significantly higher in intramural than subserosal myoma). The removal of intramural myomas >8 cm and the subserosal ones >12 cm required a significant longer surgical time. Patients returned 17.9 ± 9.5 days after surgery to their personal activities. Six cases (1.35 %) required conversion to laparotomy, and only in two cases blood transfusion was necessary. Myomas size and type represent the best predictors of surgical difficulties and possible intrapostoperative complications. Intramural myomas >8 cm and subserosal ones >12 cm should be considered as a challenging procedure. LM remains the gold standard approach because of very low perioperative complication rate and faster return to normal activity.

Color Doppler Misoprostol Response Study (CDMRS): An Evaluation Tool for Patients Awaiting Myomectomy

Background Uterine myomas (fibroids) are benign tumors of the uterus. Myomectomy, the surgical removal of myoma, is an important treatment option. The major complication associated with myomectomy is excessive bleeding. Many interventions have been used to reduce bleeding during myomectomy. Misoprostol produces uterine contraction, thereby reducing blood supply to the myometrium and in the myoma; it can be used as an alternative to uterine artery occlusion or paracervical tourniquet to reduce blood flow during myomectomy. The Color Doppler Misoprostol Response Study (CDMRS) is a study planned to assess the vascularity of the myoma in patients with fibroid uterus and note the changes after misoprostol administration. Materials and methods A baseline study of all the patients was done prior to insertion of misoprostol or placebo, and the largest selected fibroid in the patients with uterine fibroids was evaluated for its volume and perfusion by Doppler ultrasound. The resistive index (RI) was measured prior to and after administration of 800 μg misoprostol (4 tablets) per rectal insertion, after 20 minutes, and reevaluated 40 minutes postinsertion. Results Results from a t -test shows that the use of misoprostol significantly reduces the volume of fibroid from 0–20 minutes by t 0–20 [mean difference = 40.3 cm 3 , confidence interval (CI) 30.6–49.9, p = 0.000) and t 20–40 (mean difference = 36.2 cm 3 , 95% CI 30.7−41.6 cm 3 , p = 0.000). In the control group receiving four tablets of placebo no significant difference was noted in volume of the fibroid. Likewise, when we compared the RIs at different timings, the results were again in favor of misoprostol because the blood flow of myomas was substantially reduced. The RI increased from t 0–20 (mean difference = 0.26, 95% CI 0.16 cm 3 –0.38 cm 3 , p = 0.000) and t 20-40 (mean difference = 0.08, 95% CI 0.33−0.04 cm 3 , p = 0.000). In the control group receiving four tablets of placebo, no significant difference was noted in perfusion of the fibroid. Conclusion In conclusion, we suggest that all patients scheduled for myomectomy have prior CDMRS to evaluate the degree of vascularity and to assess if they have an appropriate response to misoprostol administered rectally, so that there is minimal or no blood loss during surgery. This preoperative assessment will decrease physician apprehension, with less intraoperative blood loss and morbidity.

Re-intervention after uterine leiomyoma embolisation is related to incomplete infarction and presence of submucous leiomyomas

ObjectiveTo evaluate outcome of invasive gynecological re-interventions after uterine artery embolisation (UAE) in relation to leiomyoma characteristics. DesignA cohort of 114 women with symptomatic myomas underwent UAE. Myoma characteristics were determined by contrast-enhanced magnetic resonance imaging (MRI) before and 6 months after treatment. The median follow-up time after UAE was 55.9 months; (range 20–116). Data on gynecological re-interventions were obtained for all patients and were analysed using the Kaplan–Meier method. Data were obtained on frequency of invasive re-interventions: major myoma procedures (hysterectomy, re-embolisation, laparoscopic or abdominal myomectomy) and outpatient hysteroscopic myoma procedures. Myoma characteristics with impact on outcome of re-interventions were determined by statistical analysis. ResultsTotal re-intervention rate was 35.1%. Hysterectomy was performed due to myoma related symptoms in 6.1% of patients, but 23.7% of patients underwent additional uterine procedures, mainly outpatient hysteroscopy (15%). Major myoma re-intervention correlated with the extent of the infarct at follow-up MRI (n=107). Patients had undergone major re-intervention (3 years) as follows: infarct group C (<80%, n=16) 44%, infarct group B (80–99%, n=16) 19%, and infarct group A (100%, n=75) 10.1% ((p<0.01) for both A vs B+C and A+B vs C). Major re-interventions were not associated with the presence of submucous myomas; but the hazard ratio (CI 95%) for undergoing hysteroscopic re-intervention was 8.4 (2–29) (p=0.001) in patients with submucous myomas, but 12.7 (5–35) (p<0.0001) in patients with more than one submucous myomas. ConclusionsComplete infarction after UAE reduces the need for major re-interventions. Assessment of complete infarction may be considered to improve quality in UAE procedures. Patients with more than one submucous myoma at UAE may often have hysteroscopic removal of residual myomas.

Caesarean Myomectomy is No Longer a Dreaded Job: a Case Control Study in Multiple Specialized Centre

Removal of uterine myoma during caesarean section (CS) is not commonly done due to fear of severe haemorrhage which may lead to hysterectomy. Contradicting the previous belief many studies have been showing that myomectomy during caesarean section is a safe procedure without significant increase of risk. The objective of this study is to analyze the safety and clinical outcome of caesarean myomectomy. This is a prospective study carried out in different hospitals of Faridpur district, Bangladesh from 01.01.10 up to 31.12.12. Total 16 (study group) patients had undergone caesarean myomectomy. Operation time, peroperative blood loss, post operative complications and length of hospital staying was compared with that of 32 women (control group) with caesarean section alone. The result shows that peroperative blood loss was average 350±100 ml in study group which is 50 ml more than control group. Operation time was 20 minutes more and length of hospital staying was 1 day more than control group. There was no post partum haemorrhage, no hysterectomy was done at the time of CS and there was no maternal or perinatal mortality. So, caesarean myomectomy is safe and convenient to patient and cost effective without increasing any extra risk. DOI: http://dx.doi.org/10.3329/fmcj.v8i1.16889 Faridpur Med. Coll. J. 2013;8(1): 07-10