Mark Hans Emanuel

Long-term results of hysteroscopic myomectomy for abnormal uterine bleeding

OBJECTIVE To analyze the efficacy of transcervical resection of submucous myomas and to identify prognostic factors for long-term results. METHODS Two-hundred eighty-five women were treated with transcervical resection of submucous myomas without endometrial ablation. In case of incomplete resection a repeat procedure was offered. Long-term follow-up was obtained. Recurrence was defined as the need for further surgery. The relation of several variables with the outcome was analyzed using Cox proportional hazard regression analysis. RESULTS Seventeen cases (6%) were lost to follow-up. The median follow-up was 46 months (range 1-104 months); for cases without recurrence median follow-up was 42 months (range 16-104 months). Forty-one (14.5%) patients had repeat surgery. An independent prognostic value of uterine size (P < .001) and number of submucous myomas (P < .001) for recurrence was noted. Twenty of 41 patients who had repeat surgery subsequently had a hysterectomy. None of the variables investigated predicted the need for hysterectomy. The surgery-free percentage of 165 patients with normal sized uteri and not more than two myomas was 94.3% (standard error +/- 1.8%) at 2 years and 90.3% (+/- 3.0%) at 5 years. CONCLUSION Transcervical resection of submucous myomas is a safe and effective treatment for patients with a normal sized uterus and not more than two myomas. It is an acceptable alternative for selected other patients. The need for a combined endometrial ablation is questionable. Transcervical resection of submucous myomas will give patients a high chance of averting further surgery and should modify the way patients are counseled.

A prospective comparison of transvaginal ultrasonography and diagnostic hysteroscopy in the evaluation of patients with abnormal uterine bleeding: Clinical implications

OBJECTIVE We determined the diagnostic value of transvaginal ultrasonography for endometrial and intrauterine abnormalities in patients with abnormal uterine bleeding. STUDY DESIGN Between June 1, 1992, and June 1, 1993, 279 consecutive patients underwent transvaginal ultrasonography. Findings were compared with the final diagnosis established by diagnostic hysteroscopy and histologic examination. RESULTS Transvaginal ultrasonography demonstrated a sensitivity of 0.96 and a specificity of 0.89. With a pretest probability (prevalence) of 0.42, this resulted in posttest probabilities of 0.03 in the case of a normal sonogram and 0.87 for an abnormal sonogram. The corresponding likelihood ratios were 0.04 and 9.09, respectively. CONCLUSION Transvaginal ultrasonography seems to be an effective procedure to exclude endometrial and intrauterine abnormalities. Its use could be implemented as a routine first-step procedure in patients with abnormal uterine bleeding, and it selects those in need of further diagnostic evaluation in the case of an abnormal or inconclusive sonogram.

Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training.

The purpose of this randomized controlled study was to compare conventional resectoscopy and hysteroscopic morcellation among residents in training (Canadian Task Force classification I). Sixty women with an intrauterine polyp or myoma were randomized to either hysteroscopic removal by conventional resectoscopy or hysteroscopic morcellation performed by 6 residents in training for obstetrics and gynecology (10 procedures per resident). The mean operating time for resectosocpy and morcellation was 17.0 (95% confidence interval [95% CI] 14.1-17.9, standard deviation [SD] 8.4) and 10.6 (95% CI 7.3-14.0, SD 9.5) min, respectively (p = .008). Multiple linear regression analysis showed that operating time increased significantly, for both resectoscopy and morcellator, when volume of intrauterine disorder increased. The use of the hysteroscopic morcellator reduced operating time more than 8 min in comparison to conventional resectoscopy (p < .001) when correction for volume was applied. Subjective surgeon and trainer scores for convenience of technique on a visual analog scale were in favor of the morcellator. No learning curve was observed. In conclusion, the hysteroscopic morcellator for removal of intrauterine polyps and myomas offers a good alternative to conventional resectoscopy for residents in training.

Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy

OBJECTIVE To investigate the success rate of proximal tubal occlusion with Essure devices in subfertile women with hydrosalpinges, and to observe the results of subsequent treatment with IVF. DESIGN Prospective, single-arm, clinical study. SETTING University hospital and teaching hospital. PATIENT(S) Ten women with uni- or bilateral hydrosalpinges prior to IVF. In all patients laparoscopy was felt to be contraindicated. INTERVENTION(S) Hysteroscopic placement of Essure devices in an office setting. MAIN OUTCOME MEASURE(S) Placement rate, successful proximal tubal occlusion, and pregnancy rate after IVF. RESULT(S) All patients had successful placement of the Essure devices without any complications. Proximal tubal occlusion was confirmed by hysterosalpingography in 9 out of 10 patients. A 40% ongoing pregnancy rate was achieved with 20% life births after one IVF cycle and/or frozen embryo transfer. CONCLUSION(S) Proximal occlusion of hydrosalpinges with Essure devices before IVF is a successful treatment for patients with a contraindication for salpingectomy.

An analysis of fluid loss during transcervical resection of submucous myomas

OBJECTIVE To determine the contribution of several variables to fluid loss during transcervical resection of submucous myomas. DESIGN An observational study using multiple linear regression analyses. SETTING A university-affiliated training hospital and a university department of clinical epidemiology and biostatistics. PATIENT(S) Patients with submucous myomas. INTERVENTION(S) Transcervical resection of submucous myomas and monitoring of fluid loss. MAIN OUTCOME MEASURE(S) Patient age, uterine enlargement, treatment with GnRH analogues or 8-ornithine-vasopressin, type of anesthesia, number of myomas, intramural extension of the myoma (type of myoma), and operating time were tested as variables. RESULT(S) Only intramural extension of the myoma and operating time were obviously related to fluid loss. For the other variables, such a relation was weak at best. The relation between fluid loss and operating time was not modified by any of the other variables. CONCLUSION(S) Because fluid loss is an important limiting factor in the transcervical resection of submucous myomas, special attention should be paid to reduction of the operating time and preoperative assessment of the intramural extension of the myoma to guide appropriate patient selection.

Methotrexate or expectant management in women with an ectopic pregnancy or pregnancy of unknown location and low serum hCG concentrations? A randomized comparison

STUDY QUESTION What is the treatment success rate of systemic methotrexate (MTX) compared with expectant management in women with an ectopic pregnancy or a pregnancy of unknown location (PUL) with low and plateauing serum hCG concentrations? SUMMARY ANSWER In women with an ectopic pregnancy or a PUL and low and plateauing serum hCG concentrations, expectant management is an alternative to medical treatment with single-dose systemic MTX. WHAT IS KNOWN AND WHAT THIS PAPER ADDS MTX is often used in asymptomatic women with an ectopic pregnancy or a PUL with low and plateauing serum hCG concentrations. These pregnancies may be self-limiting and watchful waiting is suggested as an alternative, but evidence from RCTs is lacking. The results of this RCT show that expectant management is an alternative to treatment with systemic MTX in a single-dose regimen in these women. STUDY DESIGN, SIZE, DURATION A multicentre RCT women were assigned to systemic MTX (single dose) treatment or expectant management, using a web-based randomization program, block randomization with stratification for hospital and serum hCG concentration (<1000 versus 1000-2000 IU/l). The primary outcome measure was an uneventful decline of serum hCG to an undetectable level (<2 IU/l) by the initial intervention strategy. Secondary outcome measures included additional treatment, side effects and serum hCG clearance time. PARTICIPANTS, SETTING, METHODS From April 2007 to January 2012, we performed a multicentre study in The Netherlands. All haemodynamically stable women >18 years old with both an ectopic pregnancy visible on transvaginal sonography and a plateauing serum hCG concentration <1500 IU/l or with a PUL and a plateauing serum hCG concentration <2000 IU/l were eligible for the trial. MAIN RESULTS We included 73 women of whom 41 were allocated to single-dose MTX and 32 to expectant management. There was no difference in primary treatment success rate of single-dose MTX versus expectant management, 31/41 (76%) and 19/32 (59%), respectively [relative risk (RR) 1.3 95% confidence interval (CI) 0.9-1.8]. In nine women (22%), additional MTX injections were needed, compared with nine women (28%) in whom systemic MTX was administered after initial expectant management (RR 0.8; 95% CI 0.4-1.7). One woman (2%) from the MTX group underwent surgery compared with four women (13%) in the expectant management group (RR 0.2; 95% CI 0.02-1.7), all after experiencing abdominal pain within the first week of follow-up. In the MTX group, nine women reported side effects versus none in the expectant management group. No serious adverse events were reported. Single-dose systemic MTX does not have a larger treatment effect compared with expectant management in women with an ectopic pregnancy or a PUL and low and plateauing serum hCG concentrations. WIDER IMPLICATIONS OF THE FINDINGS Sixty percent of women after expectant management had an uneventful clinical course with steadily declining serum hCG levels without any intervention, which means that MTX, a potentially harmful drug, can be withheld in these women. BIAS, LIMITATION AND GENERALISABILITY: A limitation of this RCT is that it was an open (not placebo controlled) trial. Nevertheless, introduction of bias was probably limited by the strict criteria to be fulfilled for treatment with MTX. STUDY FUNDING This trial is supported by a grant of the Netherlands Organization for Health Research and Development (ZonMw Clinical fellow grant 90700154). TRIAL REGISTRATION ISRCTN 48210491.

First experiences with hysterosalpingo-foam sonography (HyFoSy) for office tubal patency testing

BACKGROUND This study was conducted to describe the first experiences with hysterosalpingo-foam sonography (HyFoSy) as a first step routine office procedure for tubal patency testing. METHODS A prospective observational cohort study was started in a university affiliated teaching hospital. In 2010, 73 patients with subfertility and a low risk of tubal pathology were examined. A non-toxic foam containing hydroxymethylcellulose and glycerol was applicated through a cervical applicator for contrast sonography (HyFoSy). Tubal patency was determined by transvaginal ultrasonographic demonstration of echogenic dispersion of foam in the Fallopian tube and/or the peritoneal cavity. Only in case patency could not be demonstrated, a hysterosalpingography (HSG) was performed as a control. RESULTS In 67 out of 73 (92%) patients, a successful procedure was performed. In 57 out of 73 (78%) cases, there was no further need for a HSG. In five patients (5/73; 7%) tubal occlusion was confirmed by HSG and in five patients (5/73; 7%) there was discordance between HyFoSy and HSG. Of 73 patients, 14 (19%) conceived within a median of 3 months after the procedure. CONCLUSIONS HyFoSy is a successful procedure to demonstrate tubal patency as a first step office procedure.

Is dilatation and curettage obsolete for diagnosing intrauterine disorders in premenopausal patients with persistent abnormal uterine bleeding

Background. To determine the predictive value of dilatation and curettage (D& C) for diagnosing intrauterine disorders in patients with persistent abnormal uterine bleeding.

Essure® hydrosalpinx occlusion prior to IVF-ET as an alternative to laparoscopic salpingectomy

OBJECTIVE To investigate the success rate of proximal tubal occlusion with Essure(®) devices in subfertile women with unilateral or bilateral hydrosalpinx and to observe the results of subsequent treatment with IVF-ET and/or frozen embryo transfer. STUDY DESIGN Prospective, single-arm, clinical study in 20 women with unilateral or bilateral hydrosalpinges (all visible on transvaginal ultrasound) due to undergo IVF-ET and/or frozen embryo transfer. In all patients, laparoscopy was considered to be contraindicated due to extensive pelvic adhesions. RESULT(S) In all patients the Essure(®) devices were placed in an ambulant setting without any complications. Proximal tubal occlusion was confirmed by hysterosalpingography in 19 out of 20 patients (95%) and in 26 of 27 treated tubes (96%). After 45 embryo transfer procedures in 19 patients, 18 pregnancies with 12 live births, 6 miscarriages and 1 immature delivery (probably related to cervical insufficiency leading to chorioamnionitis and subsequent rupture of the membranes) were observed. CONCLUSION(S) Essure(®) devices are effective in inducing proximal tubal occlusion in subfertile patients with hydrosalpinges. After artificial reproductive treatments a cumulative live birth rate per patient of 63% and a cumulative live birth rate per transfer of 27% were achieved. The latter was related to the large proportion of patients with severe endometriosis.

Follow‐up after incomplete hysteroscopic removal of uterine fibroids

Background. In this observational study, we analysed whether a period of wait and see was reasonable following incomplete removal of submucous fibroids, with regard to symptoms of abnormal uterine bleeding, and whether factors predicting subsequent surgery could be identified. Methods. In 3 affiliated hospitals, patients with incomplete removal of submucous fibroids, treated with hysteroscopic myomectomy for abnormal uterine bleeding, between January 1997 and January 2005, were followed over time. Using life‐table analysis (Kaplan‐Meier method), the cumulative proportion of women having surgery‐free survival following incomplete removal of submucous fibroids was calculated. Cox‐proportional hazard analyses were used to analyse relationships of variables with recurrence of symptoms. Results. Forty‐one consecutive patients met the inclusion criteria, and were followed over time. The mean age was 42.5 years (range 27–55). The majority of patients with incomplete removal of submucous fibroids were diagnosed with type 2 fibroids. Termination of the procedure before complete removal was achieved, was principally caused by reaching the maximum fluid deficit (90.2%). The surgery‐free percentages were 70.2% (95%‐CI: 55.3–85.1) at 1 year, 54.8% (95%‐CI: 38.1–70.7) at 2 years, and 44.2% (95%‐CI: 26.9–61.5) at 3 years. Size of fibroid (diameter) pre‐operatively turned out to be of statistically significant influence, with a hazard ratio of 1.762 (95%‐CI: 1.114–2.787) per cm increase in diameter (p = 0.016). Conclusions. The results indicate that incomplete removal does not always seem to necessitate subsequent surgery. Instead of subsequent surgery immediately post‐operatively, a wait and see policy is worth considering after incomplete removal.