Increased plasma HDL-cholesterol and apo A-I in breast cancer patients undergoing adjuvant tamoxifen therapy.
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OBJECTIVE: To compare endometrial ablation using a vaporizing electrode with resection using a standard cutting loop, evaluating distension fluid absorption, operating time, and ease of procedure. METHODS: Premenopausal menorrhagic women with normal hysteroscopic and endometrial biopsy findings were allocated randomly to endometrial vaporization (n = 47) or resection (n = 44). Distension medium deficit, operating time, and degree of difficulty of the procedure were determined at surgery. Menstrual pattern of women in both groups was also assessed after 1-year follow-up. RESULTS: Mean +/- standard deviation (SD) distension fluid deficit was 109+/-126 mL in the vaporization and 367+/-257 mL in the resection group (mean difference 258 mL; 95% confidence interval 175, 341 mL; P < .001, unpaired t test). Mean +/- SD operating time was, respectively, 9.2+/-3.1 minutes versus 10.7+/-2.5 minutes. The surgeon classified intraoperative difficulties as none in 32, minimal in 11, moderate in four, and severe in none in the vaporization group, and 17, 14, seven, and six in the resection group. Menstrual pattern at 1 year in the former group was amenorrhea in 17 (36%) cases, hypomenorrhea or spotting in 20 (43%), normal flows in 10 (21%), and menorrhagia in none compared with, respectively, 21 (48%), 14 (32%), seven (16%), and two (5%) in the latter group. CONCLUSION: Endometrial ablation with the vaporizing electrode limited fluid absorption compared with resection by the standard cutting loop. Long-term effects on uterine bleeding were similar.
BACKGROUND: To evaluate histologically and histochemically the physical and thermal effects of a vaporizing electrode as compared with a standard cutting loop in the performance of endometrial ablation. METHODS: Operative hysteroscopy was performed on 20 menorrhagic patients immediately before hysterectomy. Part of the posterior uterine wall was treated with a cylindrical, grooved, vaporizing electrode and undamped current set at 200 watts, and part with a standard cutting loop and undamped current set at 100 watts. A mucosal strip of about 1 cm width was left intact between the two treatment areas. Specimens underwent histologic examination after hematoxylin and eosin staining and histochemical assessment of thermal injury was based on detection of the respiratory enzyme dihydronicotinamide adenine dinucleotide diaphorase. RESULTS: The mean (standard deviation) endometrial thickness as determined on the untreated area of the posterior uterine wall was 1.08 (0.36) mm. The mean depth of furrows was 3.10 (0.90) mm with the use of the vaporizing electrode and 3.41 (1.11) mm after passage of the cutting loop. Corresponding values when thermal necrosis beneath the ablated area was assessed by the dihydronicotinamide adenine dinucleotide diaphorase technique were, respectively, 1.80 (0.40) mm and 0.41 (0.20) mm (mean difference, 1.39 mm; 95% confidence interval, 1.19 to 1.59: p<0.001, Mann-Whitney U test). CONCLUSIONS: A vaporizing electrode and a standard cutting loop obtained a similar degree of endomyometrial ablation. However, the depth of the thermal effect of the former electrode was significantly greater. Clinical studies are warranted, also considering the potential limitation of fluid absorption and menorrhagia recurrence when a vaporizing electrode is used.
BACKGROUND: As a vaporizing electrode has been successfully used to treat submucous myomas, we evaluated its safety and efficacy in performing endometrial ablation. METHODS: Forty consecutive women with established menorrhagia with (n=26) and without (n=14) submucous myomas were enrolled in a prospective, noncomparative, pilot study. Hysteroscopic endometrial vaporization was performed with pure cutting current set at 200 watts. RESULTS: All procedures were completed without complications. Median (interquartile range, IQR) fluid deficit was 90 (0-200) ml and median (IQR) operating time 10 (7-12.5) min. A significant correlation was observed between operating time and fluid absorption (Spearman's test by ranks, r=0.47; p=0.002). The degree of difficulty of the operation was classified as none on 28 (70%) occasions, mild on 11 (27.5%) and moderate on one (2.5%). After a mean+/-s.d. follow-up of 20.3+/-2.4 months, amenorrhea or spotting were reported by 23 (57.5%) subjects, hypomenorrhea by 10 (25%), normal flows by six (15%), and menorrhagia by one (2.5%). The median (IQR) menstrual score calculated according to a pictorial blood loss assessment chart dropped from 282.5 (199-383) to 0 (0-15) (p<0.0001). Six (15%) subjects were very satisfied with the effect of surgery, 30 (75%) satisfied, two (5%) uncertain, one (2.5%) dissatisfied and one (2.5%) very dissatisfied. CONCLUSIONS: The vaporizing electrode seems to combine the benefits of the cutting loop (speed, efficacy and possibility of removing myomas) and the roller-ball electrode (safety and limited fluid absorption) while avoiding their respective disadvantages, and may be considered an interesting alternative in the hysteroscopic treatment of menorrhagia.
OBJECTIVE: To compare the effect of a levonorgestrel-releasing intrauterine device with that of endometrial resection on menstrual bleeding, patient satisfaction, and quality of life in menorrhagic women during 12 months of follow-up. METHODS: Seventy premenopausal women with dysfunctional uterine bleeding were enrolled in a prospective, open, parallel-group, controlled trial. They were randomized to either insertion of an intrauterine system releasing 20 micrograms/day of levonorgestrel (n = 35) or endometrial resection (n = 35). The women were evaluated at baseline, and thereafter, uterine bleeding was assessed monthly with a pictorial blood loss assessment chart. Clinical gynecologic examination was performed bimonthly, and the hematologic variables were measured at 6 and 12 months. On the latter occasion, the women were requested to rate the degree of satisfaction with the effect of their treatment and to complete the Short Form 36 General Health Survey questionnaire. RESULTS: Recurrent menorrhagia was observed at 12 months in four women in the intrauterine device group (including two with partial expulsion of the device) and in three women in the resection group. Compared with baseline values, at 1 year, the pictorial blood loss assessment chart score was reduced by 79% in the former group and by 89% in the latter. Amenorrhea or hypomenorrhea at 12 months was reported by 65% of the women with an intrauterine device compared with 71% who underwent endometrial resection. The degree of satisfaction with treatment was high in both groups, with 29 of 34 (85%) women being satisfied or very satisfied in the intrauterine device group versus 33 of 35 (94%) in the resection group. Health-related quality of life perception was not significantly different in the two treatment groups. CONCLUSION: Somewhat less satisfactory results were obtained with a levonorgestrel-releasing intrauterine system compared with endometrial resection for dysfunctional uterine bleeding at 1 year of follow-up.
In order to analyse risk factors for adenomyosis, 707 consecutive women who underwent hysterectomy between January 1993 and June 1994 at the Clinica Luigi Mangiagalli, Milan, Italy, were interviewed before surgery by trained physicians. Information on the presence of adenomyosis was obtained from pathologic records. Out of the 707 women, adenomyosis was identified in 150 subjects (21.2%). Women who smoked tended to be at decreased risk of the condition: in comparison with women who had never smoked, the risk for current smokers was 0.7 (0.3-1.3) and the risk decreased with number of cigarettes smoked per day, the odds ratios being 0.8 and 0.6 respectively in women reporting fewer than 10 and more than 10 cigarette smoked per day (chi2 trend 3.57, P = 0.06). The frequency of adenomyosis was higher in parous women: in comparison with nulliparae, the odds ratio of the disease were 1.8 [95% confidence interval (CI) 0.9-3.4] and 3.1 (95% CI 1.7-5.5) respectively in women reporting one and two or more births (chi2 trend 20.71, P < 0.01). Likewise, women reporting one or more spontaneous abortions had an odds ratio of 1.7 (95% CI 1.1-2.6) for adenomyosis, in comparison with those reporting no spontaneous abortion.
To verify the reliability of transvaginal ultrasonography in diagnosing intrauterine disease and in evaluating the operability of submucous myomas and to determine the feasibility, acceptability and validity of hysteroscopy for menorrhagia, we performed a prospective 5 year study on 793 women of mean age +/- SD of 41.5 +/- 7.8 years. All the patients referred for excessive menstrual bleeding with uterine volume <12 week pregnancy who underwent complete physical examination, transvaginal ultrasonography and outpatient hysteroscopy with endometrial biopsy were included in the study. Outpatient hysteroscopy was not completed due to intolerance or was unsatisfactory due to excessive bleeding in 23 cases (2.9%). Only 28 women (3.5%) declared they would have refused the procedure had they imagined the pain involved. One case of pelvic infection was observed. Compared with hysteroscopy, transvaginal ultrasonography had 96% sensitivity, 86% specificity, 91% positive predictive value and 94% negative predictive value in the diagnosis of intrauterine abnormality. The sensitivity, specificity, positive and negative predictive values of ultrasonography in identifying submucous myomas operable hysteroscopically (intramural extension <50%) were respectively 80, 69, 83 and 65% with a k index of agreement between ultrasonography and hysteroscopy of 0.48. Thus, considering the good specificity and high negative predictive value, transvaginal ultrasonography may be suggested as the initial investigation in menorrhagic patients, limiting hysteroscopy to cases with positive or doubtful sonographic findings.
We compared postoperative morbidity with the Küstner (n = 53) and Pfannenstiel (n = 131) incisions in a consecutive series of women undergoing surgery for benign gynecological conditions. The incidence of febrile morbidity (15.1% vs 23.7%, chi 2(1) = 1.19, P = 0.28) and wound infection (5.7% vs 9.2%, P = 0.56, Fisher's exact test) were higher in the Pfannenstiel then in the Küstner group, but neither difference was statistically significant. One suprafascial hematoma was observed after a Küstner incison compared with eight subfascial hematomas after a Pfannenstiel incision (1.9% vs 6.1%, P = 0.45, Fisher's exact test). The postoperative hospital stay was statistically significantly lower in the Küstner than in the Pfannenstiel group (6.3 +/- 1.4 vs 7.1 +/- 1.2 days, P < 0.01, Student's t test). The Küstner incision warrants further evaluation and usage.
OBJECTIVE: Our purpose was to evaluate the efficacy and safety of depot medroxyprogesterone acetate versus an oral contraceptive combined with very-low-dose danazol in the long-term treatment of pelvic pain in women with endometriosis. STUDY DESIGN: Eighty patients with endometriosis and moderate or severe pelvic pain were randomized to treatment for 1 year with intramuscular depot medroxyprogesterone acetate 150 mg every 3 months or a cyclic monophasic oral contraceptive (ethinyl estradiol 0.02 mg, desogestrel 0.15 mg) combined with oral danazol 50 mg a day for 21 days of each 28-day cycle. The women were asked to grade the degree of their satisfaction at the end of therapy. Variations in severity of symptoms during treatment were determined by a 10 cm visual analog and a 0- to 3-point verbal rating scale. RESULTS: Twenty nine of 40 subjects (72.5%) in the depot medroxyprogesterone acetate group were satisfied after 1 year of therapy compared with 23 of 40 (57.5%) in the oral contraceptive plus danazol group (chi 2(1) = 1.37, p = 0.24, odds ratio 1.95, 95% confidence interval 0.76 to 4.97). A significant decrease was observed in all symptom scores in both study groups. At 1-year assessment dysmenorrhea was significantly greater in women allocated to oral contraceptive plus danazol. CONCLUSION: Depot medroxyprogesterone acetate seems to be an effective, safe, and convenient low-cost treatment for pelvic pain associated with endometriosis. However, women should be carefully counseled regarding menstrual changes and the potential prolonged delay in the return of ovulation.
To verify the technical feasibility and safety of endometrial ablation with a vaporizing electrode (Vaportrode), we performed operative hysteroscopy in a consecutive series of 40 women (mean ± SD age 45.3 ± 4.7 yrs) with established menorrhagia and uterine volume less than 12 weeks' gestation. The results in 26 women with a regular uterine cavity were compared with those in 14 patients who had submucous myomas with less than 50% intramural extension. Surgery was undertaken after 2-month treatment with a depot gonadotropin-releasing hormone agonist. Pure cutting current was set at 200 W. Mean ± SD operating time was 8.6 ± 2.4 minutes in women with a regular cavity and 14.4 ± 5.2 in those with submucous myomas (mean difference 5.8 minutes, 95% CI 3.4-8.3). Corresponding values for distention fluid absorption were, respectively, 76 ± 103 and 227 ± 138 ml (mean difference 151 ml, 95% CI 73-229). A significant correlation was observed between operating time and distention fluid deficit (Spearman r = 0.47, p = 0.002). No complications occurred and all the procedures were performed as day surgery. After a mean follow-up of 4 months, no recurrence of menorrhagia was reported. Endometrial ablation with the Vaportrode is rapid, effective, and safe. Fluid deficit, although significantly greater in women with submucous myomas than in those with regular cavities, always remained within safety limits and below the usual values observed after resection with the wire loop.
To ascertain whether treatment with a gonadotropin-releasing hormone agonist before endometrial resection reduces absorption of distention fluid and operating time, facilitates the procedure, and improves long-term bleeding pattern, 71 menorrhagic women were allocated to 8 weeks of goserelin depot treatment before operative hysteroscopy or immediate surgery in the early proliferative phase of the cycle. Eight patients withdrew from the study after randomization, leaving 33 in the goserelin arm and 30 in the immediate surgery arm. Mean (SD) operating time was 15.1 (9.0) minutes in the goserelin group versus 16.9 (9.5) minutes in the controls (mean difference 1.8 min, 95% CI -2.9-6.4). Mean (SD) distention medium deficit was, respectively, 422 (287 ml) and 564 ml (291 ml; mean difference 142 ml, 95% CI -4-288). Considering only the 29 women with adenomyosis, the mean (SD) fluid deficit was considerably less in the 19 goserelin-treated group than in the 10 controls, 299 (206) versus 597 (135) ml (mean difference 298 ml, 95% CI 149-447). The surgeons classified intraoperative difficulties as none in 6, minimal in 20, moderate in 7, and severe in no cases in the goserelin group; corresponding figures in the group without pretreatment were 2, 14, 13, and 1 (p = 0.02). At 12-month follow-up 35% of women in the goserelin group were amenorrheic, 23% hypomenorrheic, 42% eumenorrheic, and none hypermenorrheic. Corresponding figures in the immediate surgery group were, respectively, 20%, 30%, 37%, and 13%. Goserelin administration before endometrial resection may reduce absorption of fluid at surgery in some patients and may facilitate intrauterine operating conditions. Effects on long-term bleeding patterns were limited.
An open-label randomized pilot study was conducted to evaluate the efficacy and acceptability of 6 months treatment with leuprolide in a 3-monthly versus a monthly i.m. depot injection for the relief of chronic pelvic pain in women with endometriosis. A total of 30 women aged 18-38 years were allocated to the 3-monthly depot arm (n = 15) or to the monthly depot arm (n = 15) after laparoscopic diagnosis of pelvic endometriosis. Mean (SD) deep dyspareunia scores according to a 0-3 point verbal rating scale decreased from 1.8 (0.9) at baseline to 1.3 (0.7) at the end of treatment in the 3-monthly depot group and from 2.1 (1.2) to 1.3 (0.7) in the monthly depot group. Corresponding values in non-menstrual pain scores fell from 2.1 (0.6) to 1.1 (0.3), and from 2.1 (0.8) to 1.2 (0.4) respectively, without statistically significant differences between the groups. Serum luteinizing hormone (LH) and 17 beta-oestradiol concentrations were significantly suppressed at 12 and 24 weeks compared with baseline values, without differences between the groups. The monthly depot caused a slightly more marked inhibition of serum follicle stimulating hormone (FSH) levels with respect to the 3-monthly preparation. Mean (SD) endometriosis scores at baseline and at 6-month follow-up laparoscopy were respectively 32.8 (25.1) and 12.2 (9.3) in the 3-monthly depot group and 29.0 (22.7) and 13.1 (15.3) in the monthly depot group (paired t-test, P < 0.05). Mean percentage decrease in lumbar spine bone mineral density was 5.2% in the former and 4.9% in the latter subjects. In the 3-monthly depot group, 13 women graded the tolerability of their treatment schedule as "good' compared with seven in the monthly depot group (chi 2 = 5.40, P = 0.02).
OBJECTIVE: To clarify whether preoperative treatment with gonadotropin-releasing hormone (GnRH) agonists offers substantial advantages to patients undergoing conservative or definitive surgery for uterine leiomyomas. STUDY DESIGN: A review of data from the most recent English-language literature. RESULTS: Inducing amenorrhea in patients with heavy menorrhagia and severe sideropenic anemia before both conservative and definitive surgery for uterine fibroids raises hemoglobin and hematocrit values to within the normal range, limits homologous blood transfusions and enables operations to be scheduled with the patients in better condition. A temporary 30-50% reduction in mean uterine volume theoretically may convert an abdominal into a vaginal hysterectomy in "borderline" cases or sometimes allow a transverse instead of longitudinal abdominal incision. No trial has yet demonstrated "clinically" significant reductions in operating time, operative blood loss or postoperative morbidity in patients undergoing myomectomy or hysterectomy after a course of GnRH agonists as compared with those operated on immediately. There seems insufficient scientific evidence to justify the routine use of GnRH agonists before myomectomy at laparotomy, except possibly in the case of extremely bulky uteri. GnRH agonist treatment before hysteroscopic myomectomy induces endometrial thinning, reduces bleeding and mucous debris, and decreases the diameter of submucous leiomyomas, improving visibility and limiting operating time and fluid intravasation. CONCLUSION: The available data seem to support the use of GnRH agonist treatment before surgery for uterine leiomyomas in selected circumstances. Administration of GnRH agonist for only two or three months preoperatively seems to achieve all the advantages of this treatment, limiting side effects and cost.
A prospective collection of serum samples and ovarian cyst fluid was used to assess the use of different tumour markers and cyst fluid cytology in combination with serum tumour markers for the differential diagnosis of benign ovarian cysts. A consecutive series of 108 women of median age 30 years (range 15-75) undergoing laparotomy or operative laparoscopy for presumedly benign ovarian cyst(s) were studied at a teaching hospital at the University of Milan, Italy. The main outcome measures were tumour markers CA 125, CA 19.9 and carcino-embryonic antigen (CEA) in serum and ovarian cyst fluid, oestradiol and progesterone concentrations in cyst fluid, and cytology of the sediment. The studied cysts were endometriotic (55 subjects), dermoid (16), mucinous (12), serous (10) or of miscellaneous histotype (15, including four follicular and one luteal). Serum CA 125 concentrations were significantly higher in the endometrioma patients than in the other groups. The sensitivity of CA 125 in the differentiation of endometriomas from other adnexal tumours was 61.8% and the specificity 94.3%; combining CA 125 and CA 19.9 assays yielded a sensitivity of 83.6% and specificity of 62.3%. Cyst fluid tumour markers values were extremely scattered with ample overlap between different cyst types. Oestradiol and progesterone concentrations were similar in the histological subgroups. Cyst fluid cytology was non-specific. We concluded that the aspiration of fluid from presumedly benign ovarian cysts appears to contribute little to the differential diagnosis of various tumours. The use of combining serum CA 125 and CA 19.9 assays in the diagnosis of endometriomas needs further confirmation.
To evaluate the prevalence and risk factors for adenomyosis, the clinical records of consecutive women undergoing hysterectomy during a 3 year period were retrieved. Data were collected on indication for the intervention, general sociodemographic characteristics of the patients, age at menarche, parity, abortions, and menopausal status at surgery. Adenomyosis was diagnosed in 332 of the 1334 cases (24.9%). The condition was present in 146 of the 627 patients (23.3%) with fibroids and menorrhagia, 68 of the 265 (25.7%) with prolapse, 21 of the 98 (21.4%) with ovarian cysts, 19 of the 100 (19%) with cervical cancer, 31 of the 110 (28.2%) with endometrial cancer, 16 of the 57 (28.1%) with ovarian cancer, and 19 of the 77 (24.7%) with miscellaneous indications. These differences were not statistically significant (chi 2(6) = 11.14). In comparison with nulliparous women, the odds ratio was 1.3 and 1.5 respectively in women with one and > or = two births (chi 2(1) trend = 5.76 P < 0.05). No relationship was found between age at surgery, age at menarche, indications for surgery, menopausal status at intervention, and presence of endometriosis. Our findings do not support the notion that adenomyosis is more frequently related to particular clinical conditions, and suggest that parity may be associated with an increased frequency of adenomyosis.
Serum and cystic fluid levels of CA 125, CA 19.9, carcinoembryonic antigen (CEA), and alpha-fetoprotein (AFP) were assayed in 74 consecutive women of median age 30 years (range 15 to 74 years) undergoing surgery for adnexal cysts of presumed benign nature. Median (range) serum levels of CA 125, CA 19.9, CEA and AFP were 46.5 IU/ml (4.3-406), 28.5 IU/ml (1-96.3), 1.4 ng/ml (0.5-3.5) and 2.4 ng/ml (1-9.9) in 44 endometriotic cysts; 22.5 (4.7-82), 4.9 (1-226),1.3 (0.7-4.8) and 4 (0.5-10.5) in 11 dermoid cysts, 14 (8.6-25.1), 3.2 (1-6), 1 (0.3-2.8) and 3.7 (1.9-6) in 9 mucinous cysts, and 6.9 (0.5-104), 18 (1-132), 0.8 (0.1-1.9) and 2.1(1-5.4) in 10 cases with mixed histotypes. Corresponding cystic fluid levels were 342,864 (1,418-3,404,682), 228,000 (117-2,500,000), 106 (0.5-2,908) and 1.3 (0.4-51) in endometriomas; 843,895 (10,842-1,676,948), 740,039 (77-1,280,000), 470 (61-880) and 2.5 (1-4) in dermoids; 3,485 (27.2-149,804), 9,007 (36.4-153,475), 1,631 (402-11,096) and 1 (0.5-2.5) in mucinous cysts, and 13,068 (5,300-43,767), 412 (1-142,700), 0.8 (0.4-5.3) and 2.3 (1-4) in the mixed histotype group. No significant between group differences were detected in serum marker levels. Patients in the mucinous cyst group had significantly lower CA 125 cystic fluid levels compared with women with endometriomas and dermoids (P<0.05). Fluid aspirate tumor marker measurements did not aid in the differential diagnosis of benign ovarian cysts, mainly due to the extremely wide scattering of values.
No activating mutations in codons 12, 13 and 61 of ras genes nor inactivating mutations in exons 5-9 of the p53 tumor suppressor gene were detected by polymerase chain reaction and single-strand conformation polymorphism methods in either eutopic or ectopic endometrium from 10 women with severe endometriosis.
When correcting a complete uterine septum, it is recommended that one should spare the cervical portion to avoid the possible risk of cervical incompetence. However, it may be difficult to create a communication between the uterine cavities above the internal os. In seven patients with complete septate uterus we incised the cervical portion with Metzenbaum scissors and the corporal portion with microscissors under hysteroscopic guidance. The operating times were shorter and the distension fluid deficit smaller compared with nine historical controls in whom the cervical septum was spared. No intraoperative or obstetric complications were associated with cervical septal section. This modified technique is simple, rapid, safe, inexpensive, and may be considered among the alternative treatments to correct a complete septate uterus.