Subcutaneous Implantation of Pure Crystalline Estradiol Pellets for Conception ControlOettinger, Moshe; Oettinger, Moshe; Barak, Shlomi; Barak, Shlomi; Oettinger-Barak, Orit; Oettinger-Barak, Orit; Ophir, Ella; Ophir, Ella
doi: 10.1159/000082652pmid: 15591820
Objectives: Assessment of the contraceptive effectiveness of pure estradiol pellets implanted annually under the skin, thus avoiding the ‘first passage phenomenon’ through the liver, using a modification of Emperaire and Greenblatt’s method. Study Design: 228 women wishing birth control for 1 year or more were included. 5 pellets of estradiol (25 mg each) were implanted initially. At each subsequent annual treatment, 4 pellets were implanted. Withdrawal bleeding was induced monthly with oral norethindrone acetate 5 mg taken for 7 days. Our experience encompassed 8,136 cycles, or 678 women years. The study obtained approval of the local Ethical Committee. Results: Annual continuation rates were 51 per 100 women in the second year, 65 in the third, 72 in the fourth and 84 ± 10.1 annually over the next 6 years. Through 12 years of our study, 2 accidental pregnancies occurred. The annual net cumulative pregnancy rates were 0.44 and 0.48 per 100 women at 1 and 2 years, and reduced to 0.29 at the end of 10 years. Return of fecundity after discontinuing treatment was 53% after 12 months, 81% after 24 months and 89% after 36 months. The mean estradiol levels were 1,413 ± 161 pmol/l one week following the pellet installation. The mean serum estradiol level of the 43 women who were assayed arbitrarily or a year following last insertion was 1,207 pmol/l (range 462–2,904 pmol/l); 22% had serum estradiol levels <1,000 pmol/l and 6.3% (3 women) had levels >1,750 pmol/l. A total of 28 endometrial biopsies were obtained –19 were proliferative, 6 showed slight simple hyperplasia, and three, benign cystic glandular hyperplasia. Conclusion: Subcutaneous implantation of pure estradiol pellets offers excellent birth control, has minimal untoward effects, is simple to insert and can serve as a possible alternative for conception control. It could be considered for 3 indications: for women who have completed family planning; for women in older age group (above 35 years) who are approaching the climacteric; and for women at any age, who need prolonged periods of contraception.
Report of an Early Stopped Randomized Trial Comparing Cisplatin vs. Cisplatin/Ifosfamide/ 5-Fluorouracil in Recurrent Cervical CancerCadron, Isabelle; Jakobsen, Anders; Vergote, Ignace
doi: 10.1159/000082750pmid: 15604591
This paper reports on an early stopped prospective randomized phase III trial comparing cisplatin, ifosfamide and 5-fluorouracil (PIF) with cisplatin monotherapy in the treatment of recurrent cervical cancer. The aim of the study was to compare response rates, survival, side effects and quality of life. Cisplatin monotherapy was given in a dose of 37.5 mg/m<sup>2</sup> on days 1 + 2 of 4-week schedules. In the PIF regimen, cisplatin was given in the same manner, ifosfamide in a dose of 2 g/m<sup>2</sup> on days 1 + 2 together with mesna 0.5 g/m<sup>2</sup>, 5-fluorouracil 500 mg/m<sup>2</sup> on days 1 + 2, and folinic acid 30 mg/m<sup>2</sup> also on days 1 + 2. This regimen was also given in 4-week schedules. The intention had been to include 200 patients in the trial but because of poor accrual the trial was stopped prematurely. Twenty-four patients were included, 3 of which not eligible, and of the remaining 21 patients, 11 were randomized to the cisplatin group and 10 to the PIF group. Median survival for the cisplatin group amounted to 13 months and for the PIF regimen to 12.3 months. The most important side effects were hematologic, with more thrombocytopenia and leukopenia in the PIF regimen. The response rate for the PIF regimen was 40% (4 partial remissions) and 9% for the cisplatin group (1 complete remission). No firm conclusions can be drawn from this trial due to the low number of participants. Still, we believe that the response and survival rates observed with PIF are interesting and that it is important to report all trials, even if they are stopped earlier than intended.
Management of Pelvic Lymphocysts by Ultrasound-Guided Aspiration and Minocycline SclerotherapyLiu, Fu-Shing; Hung, Man-Jung; Hwang, Sheau-Feng; Lu, Chien-Hsing; Ke, Yu-Min; Ho, Esther Shih-Chu
doi: 10.1159/000082889pmid: 15627779
Objective: The purpose of this study was to describe our experience with ultrasound-guided aspiration of postoperative pelvic lymphocysts followed by intracavitary minocycline injection as sclerotherapy. Patients and Methods: From 1997 to 2003, patients who developed either symptomatic or persistent lymphocyst after pelvic lymphadenectomy for gynecological malignancy were recruited in this study. All of the lymphocysts were palpable and were further examined by ultrasonography. Percutaneous ultrasound-guided needle aspiration of the lymphocyst was performed and then immediately followed by a single-dose injection of minocycline into the collapsed cavity. Follow-up was conducted every 4 weeks with pelvic examination and ultrasonography. Results: Nineteen patients with a total of 21 pelvic lymphocysts underwent this procedure. The median size of the lymphocysts was 6 cm in diameter (range, 4–9 cm). Fifteen patients received 1 treatment, 3 received 2, and 1 patient with bilateral lymphocysts received 3 treatments. Complete resolution occurred in 14 patients (74%), and the other 5 patients (26%) had partial resolution with the volume of the lymphocyst decreasing at least 50%. For the 14 patients with complete resolution, the median time from treatment to disappearance of the lymphocyst was 3 months (range, 1–10 months), and none of them developed recurrence during the average follow-up period of 40 months (range, 2–62 months). No significant complication occurred with this procedure except for transient mild to moderate pelvic pain. Discussion: Minocycline sclerotherapy seems to be a simple and safe method with a satisfactory success rate in treating lymphocysts which develop after pelvic lymphadenectomy. It can be performed in an outpatient setting and can be repeated if necessary. This procedure may be considered as the initial treatment modality for patients suffering from symptomatic or persistent lymphocysts after radical gynecological surgery.
Etiology and Outcome of Non-Immune Hydrops fetalis in Southern ThailandSuwanrath-Kengpol, Chitkasaem; Kor-anantakul, Ounjai; Suntharasaj, Thitima; Leetanaporn, Roengsak
doi: 10.1159/000082997pmid: 15637431
Objective: To study the etiology and outcome of non-immune hydrops fetalis in southern Thailand. Methods: The medical records and videotape recordings of all pregnant women diagnosed with non-immune fetal hydrops, from January 1993 to December 2002 were reviewed. Results: Non-immune hydrops fetalis was documented in 71 cases. The causes of fetal hydrops were identified in 87.3%. Homozygous α-thalassemia-1 dominated as the cause of non-immune fetal hydrops (28.2%), followed by structural abnormalities (15.5%) and infection (12.7%). The underlying etiology remained unknown in 9 cases (12.7%). The overall survival rate of non-immune hydrops fetalis cases was 4.2%. Spontaneous regression occurred in 2 cases. Two cases were lost to follow up after initial evaluation. Termination of pregnancy was performed in 47 cases. There were 12 dead fetuses in utero, 2 stillbirths, 5 early neonatal deaths and only 3 cases survived. Conclusions: Homozygous α-thalassemia-1 is the most common cause of non-immune hydrops fetalis in southern Thailand, and the overall prognosis of non-immune hydrops fetalis is poor. We suggest that an effective thalassemia-screening program for prevention and control of homozygous α-thalassemia-1 be established in all areas where the α-thalassemia-1 gene is prevalent.
Successful Pregnancy and Delivery after Removal of Gonadotrope Adenoma Secreting Follicle-Stimulating Hormone in a 29-Year-Old Amenorrheic WomanSugita, Tatsuya; Seki, Katsuyoshi; Nagai, Yuichiro; Saeki, Naokatsu; Yamaura, Akira; Ohigashi, Sawako; Iwata, Arifumi; Tatsuno, Ichiro; Sekiya, Souei
doi: 10.1159/000083087pmid: 15637432
We report a case of ovarian hyperstimulation related to a gonadotroph adenoma in a 29-year-old woman. The patient presented with amenorrhea and large cystic ovaries. Her serum estradiol was markedly elevated (up to 31,100 pmol/l). Serum LH was low, but serum FSH and PRL were normal. Cranial magnetic resonance imaging study revealed a pituitary macroadenoma. After successful removal of the pituitary tumor, FSH, LH and estradiol normalized and fluctuated within normal ranges thereafter. The patient resumed regular cycles of menstruation and conceived spontaneously. During pregnancy, estradiol increased and FSH and LH decreased. The finding confirms restoration of negative feedback of estradiol on FSH and LH secretion. The pregnancy course was uneventful and enlargement of ovaries did not occur.
Subcutaneous Nephrovesical and Nephrocutaneous BypassJurczok, A.; Loertzer, H.; Wagner, S.; Fornara, P.
doi: 10.1159/000083088pmid: 15637433
Objective: We evaluated the effectiveness of the subcutaneous bypass for ureteral obstruction in patients with advanced malignancies. Two versions of the minimally invasive technique were performed: nephrovesical and nephrocutaneous bypass. Methods: A specially designed composite implant consisting of an inner smooth silicone-covered tube covered by a coiled e-PTFE-tube was used in 14 patients. Results: 10 subcutaneous nephrovesical bypasses were inserted in 10 patients, 8 nephrocutaneous bypasses in 4 patients. During the mean follow-up period of 13.1 months complications were observed in 2 patients with nephrocutaneous bypass, one encrustation and one infection of the bypass system. Conclusions: The subcutaneous nephrovesical and nephrocutaneous bypass is a safe alternative for palliative treatment of ureteral obstruction caused by pelvic malignancy.
Transvaginal Ultrasonography and Endometrial Cytology as a Diagnostic Schema for Endometrial CancerMinagawa, Yukihisa; Sato, Shinya; Ito, Masayuki; Onohara, Yoshimasa; Nakamoto, Shu; Kigawa, Junzo
doi: 10.1159/000083089pmid: 15637434
Objective: To determine whether the combined use of transvaginal ultrasonography and endometrial cytology is an effective diagnostic schema for endometrial cancer and hyperplasia of the uterus. Methods: Five hundred fifty-two women were enrolled in this study. For all subjects, endometrial thickness was evaluated by transvaginal ultrasonography. Endometrial cytology was carried out according to the following criteria: all women with atypical uterine bleeding, for asymptomatic postmenopausal women with endometrial thickness ≧5 mm, and for asymptomatic premenopausal women with endometrial thickness ≧20 mm. When the cytological findings were abnormal, we performed a hysteroscopy-guided biopsy within 2 weeks. Women who received transvaginal ultrasonography alone, or those who showed negative cytology, underwent repeated gynecological examination and transvaginal ultrasonography 3, 6, and 12 months after the first examination. Results: Endometrial cytology was done on 129 women (23.4% of all subjects), of whom 14 were diagnosed as ‘positive’ cytology, 20 as ‘suspicious positive’, and 95 as ‘negative’. A total of 34 women with ‘positive’ or ‘suspicious positive’ cytological result underwent hysteroscopy-guided endometrial biopsy. The histological diagnosis of the endometrium included 13 endometrial cancers, 9 endometrial hyperplasias (one atypical hyperplasia and 3 hyperplastic polyps), and 10 normal endometria. As a diagnostic schema for endometrial cancer, this combined method resulted in 100% sensitivity, 99.1% specificity, 92.9% positive predictive value, and 100% negative predictive value. For endometrial hyperplasia, the method resulted in 100% sensitivity, 89.6% specificity, 40.0% positive predictive value, and 100% negative predictive value. Conclusion: A combination of transvaginal ultrasonography and endometrial cytology may be an effective diagnostic schema for endometrial cancer and hyperplasia.
Misoprostol 50 μg Sublingually versus Vaginally for Labor Induction at Term: A Randomized StudyCaliskan, Eray; Bodur, Harika; Ozeren, Semih; Corakci, Aydin; Ozkan, Sabiha; Yucesoy, Izzet
doi: 10.1159/000083255pmid: 15640607
Objective: To compare the efficacy of misoprostol 50 µg vaginally and 50 µg sublingually for labor induction at term. Materials and Methods: One hundred and sixty women were randomized to receive misoprostol 50 µg vaginally (n = 80) or 50 µg sublingually misoprostol (n = 80). The doses were given every 4 h (maximum 6 doses). Primary outcome measure was number of cesarean deliveries. Induction to delivery time, delivery within 24 h, the number of misoprostol doses given; the need for oxytocin augmentation, tachysystole and uterine hyperstimulation rates and neonatal outcomes were secondary outcome measures. Results: The mean induction to delivery time was 748 ± 379 min in the vaginal group and 711 ± 425 in the sublingual group (p = 0.56). The number of women delivering within 24 h was 73 (91.3%) in the vaginal group and 74 (92.5%) in the sublingual group (p = 0.78). The mean number of misoprostol doses required was significantly higher in the sublingual group (1.9 ± 1.2) compared with the vaginal group (1.1 ± 0.4; p < 0.001). More women in the sublingual group experienced tachysystole (n = 14, 17.5%) compared with the vaginal group (n = 3, 3.8%; p = 0.005). Seven cases (8.8%) in the vaginal group and 12 cases in the sublingual group (15%) required emergent cesarean delivery for fetal heart rate abnormalities (p = 0.22). Other neonatal outcomes including umbilical artery pH, Apgar scores and intensive care unit admission were similar in the two groups. Conclusion: Sublingual misoprostol is as efficacious as vaginal misoprostol for induction of labor. More frequent tachysystole is observed with misoprostol 50 µg sublingually, but neonatal outcomes are similar.
Mucocele of the Vermiform Appendix with Sonographic Appearance of an Adnexal MassDragoumis, K.; Mikos, T.; Zafrakas, M.; Assimakopoulos, E.; Venizelos, I.; Demertzidis, H.; Bontis, J.
doi: 10.1159/000083680pmid: 15687730
Mucocele of the vermiform appendix is caused by mucus retention in its lumen, due to obstruction or hyperproduction. Appendiceal malignancy can be the underlying cause, making accurate preoperative diagnosis imperative. In women, it can sometimes present as an adnexal mass. A rare case of an appendiceal mucocele is presented, mimicking a cystic tumor of the right adnexum, both clinically and ultrasonographically. In addition, serum levels of CA-125 were increased. This is the first case of a mucocele of the appendix simulating an adnexal mass on ultrasound with increased levels of CA-125 to be reported. This clinical entity should be considered in patients presenting on ultrasound with a right-sided adnexal mass as a rare potential diagnosis.
Feasibility of Radical Surgery in the Management of Elderly Patients with Uterine Cervical Cancer in KoreaChoi, Young Sik; Kim, Yun Hwan; Kang, Sokbom; Jeon, Yong Tark; Kim, Jae Weon; Park, Noh Hyun; Song, Yong Sang; Kang, Soon Beom; Lee, Hyo Pyo
doi: 10.1159/000083681pmid: 15677871
To evaluate the tolerance and the outcome of radical surgery in the management of elderly patients with uterine cervical cancer in Korea, seventy-seven patients with stage Ib or IIa squamous cell carcinoma of the uterine cervix, diagnosed at Seoul National University Hospital from January 1996 to June 2003, were retrospectively reviewed. Sixty-six patients undergoing radical surgery were divided into two groups according to their age: 41–50 years (group A; n = 43) and 65 years or older (group B; n = 23). Statistical analysis was conducted by using Mann-Whitney U test and Fisher’s exact t test. Although group B consists of more stage IIa cases than group A (27.9 vs. 52.2%), the difference in the stage between both groups was statistically insignificant. Medical comorbidities in group B were higher than group A, primarily due to hypertension (23.3 vs. 56.5%, p = 0.014). Mean operation time, mean blood loss, perioperative transfusion, frequency of intraoperative injuries, duration of hospital stay, and postoperative complications were similar except 1 case of operation-related mortality in group B. The pathologist’s report indicated a positive resection margin of the vagina in 6 cases of group B but none in group A. The difference in parametrial involvement, lymph node involvement, lymphovascular space invasion, deep cervical wall involvement and larger tumor with a diameter >4 cm was not significant. The number of patients who received adjuvant therapy was significantly higher in group B than group A (23.3 vs. 65.2%, p = 0.001). The recurrence rate, however, was not different. Our study suggests that radical surgery in the management of elderly patients with stage Ib or IIa uterine cervical cancer is reasonably feasible. Chronological age alone should not be considered a contraindication to radical hysterectomy.