[Show abstract][Hide abstract] ABSTRACT: PURPOSE: The objectives of this study were to evaluate local disease control, overall survival (OS), disease-free survival (DFS) and local relapse-free survival (LRFS) in patients with endometrial cancer undergoing adjuvant vaginal brachytherapy (VBT)±external-beam radiotherapy (EBRT). MATERIALS AND METHODS: From September 2007 to February 2011, 40 patients with endometrial cancer were retrospectively analysed. Surgery consisted of total hysterectomy and bilateral salpingo-oophorectomy without node dissection (16 patients) or with bilateral pelvic node dissection (24 patients). The stage distribution was as follows: two IA, nine IB, 12 IC, five IIA, eight IIB, two IIIA and two IIIC. Thirty-four patients underwent EBRT and VBT. Six patients received VBT alone. RESULTS: Median follow-up was 26 months. The 5-year OS and DFS were 96.4% and 86.9%, respectively. No local recurrence was observed. Four patients presented distant disease (three had lung metastases and one had hepatic node metastases). Acute EBRT-related toxicities were seen in 15 (38%) patients. We recorded late toxicities in 14 patients (35%). There was no evidence of grade 3-4 toxicity. CONCLUSIONS: Adjuvant EBRT and/or VBT in patients with endometrial cancer showed good outcomes in terms of local disease control, with an acceptable toxicity profile.
La radiologia medica 05/2012; · 1.46 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To present a case of successful management of a heavily bleeding cervical ectopic pregnancy with ultrasound-guided termination procedure of evacuation.
A 34-year-old woman, secundigravida with one previous full-term natural childbirth and history of one spontaneous abortion, with a cervical pregnancy.
Prophylactic suture ligation of the cervicovaginal branches of the uterine artery, with absorbable sutures at the 3 and 9 o'clock positions of the cervix. Evacuation, with dilatation and curettage, under transabdominal ultrasound guidance was performed. Control of hemorrhage by placing a running-lock absorbable suture around the entire edge of the cervix followed by cervical packing with iodoform gauze medicated with anticoagulant drugs.
Recovery of the patient, successful conservative treatment of the cervical ectopic pregnancy, with preservation of the uterus.
The cervical ectopic pregnancy was successfully evacuated, and the reproductive capability of the patient was preserved.
Ultrasound-guided evacuation with prophylactic closure of the cervical branches of the uterine artery and application of a running-lock suture around the cervix can be used in case of heavily bleeding cervical ectopic pregnancy.
Fertility and sterility 02/2011; 95(6):2123.e3-4. · 3.97 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Treatment for mild and moderate endometriosis is controversial, whereas ovarian endometriomas of diameter > 3 cm must be treated surgically. A minimally invasive and inexpensive surgical approach should be always preferred. The objective of this randomized, prospective, clinical trial was to assess operative time, hemostasis, accuracy, recurrence rates, and pregnancy outcomes of 2 different laparoscopic techniques for management of ovarian endometriomas.
Ninety-two patients with ovarian endometriomas were randomized to undergo direct stripping of cystic wall from the initial adhesion site (group A), or circular excision of ovarian tissue around the initial adhesion site and then stripping (group B). Pregnancy outcome results were retrieved at 36 months after surgery. Recurrence rate corresponded to evaluation at 4 and 12 months after surgery performed by transvaginal ultrasound and Ca125 serum level.
Direct stripping leads to bleeding more frequently than does circular excision. Hemostasis at the ovarian hilus does show differences between groups; an easy exposure of damage after circular excision reduces execution time. Cumulative pregnancy outcomes at 36 months, and recurrence rates during follow-up, did not significantly differ among techniques.
Circular excision of endometrioma cystic wall reduces surgical time, and results in better hemostasis. In addition, excision techniques allow complete removal of the cystic wall in 93% of cases (compared to 74.5% for direct stripping technique), showing differences in recurrence rate, and bringing about a better pregnancy. Data are not statistically significant owing to the small number of collected cases.
Medical science monitor: international medical journal of experimental and clinical research 04/2010; 16(4):MT45-50. · 1.22 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the occurrence of endometrial polyp malignancy in pre- and postmenopausal women with or without symptoms.
A retrospective study was performed on 351 patients with endometrial polyps diagnosed by hysteroscopy.
Histological findings of biopsies obtained by operative hysteroscopy confirmed the presence of a simple endometrial polyp in 179 cases, polyps with typical simple hyperplasia in 42 cases, polyps with typical complex hyperplasia in 24 cases, polyps with atypical complex hyperplasia in three cases; carcinomatous polyps in seven cases; atrophic polyps in 17 cases; functional polyps in 56 cases; and inadequate sample in 23 cases. All seven patients with adenocarcinoma were symptomatic; six out of seven patients with adenocarcinoma were in postmenopause and one was in premenopause. The association between menopausal status and symptoms, and the presence of a malignant lesion was statistically significant (p < 0.001).
This study revealed that prevalence of endometrial polyp malignant transformation was < or = 2.84% in postmenopausal and symptomatic patients.
European journal of gynaecological oncology 01/2010; 31(2):165-8. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To assess the role of neoadjuvant chemotherapy to achieve radical surgery in a larger number of patients with locally advanced/or bulky Stage IB cervical carcinoma. We conducted a trial to determine whether neoadjuvant chemotherapy would improve disease-free survival and overall survival in Stage IB-III cervical cancer.
Prospective randomized clinical study with long-term follow-up.
Department of Gynecology, Perinatology and Child Health, II Faculty University of Rome "La Sapienza".
288 patients with squamous cell carcinoma of the uterine cervix, FIGO Stage IB-IIIB were randomized to one of the following treatments: three courses of neoadjuvant chemotherapy with cisplatin, vincristine, bleomycin (NACT arm; n = 159); conventional surgery or exclusive radiotherapy (CONV arm; n = 129). There was no difference in age, FIGO stage, tumor size and lymph node involvement between the two groups (p = ns). Two hundred and thirty-four patients in Stage IB-IIb (n = 129 NACT arm and n = 105 CONV arm) and 24 patients in Stage III (NACT arm) who proved to be chemosensitive underwent radical hysterectomy. Six Stage III patients, non responders to chemotherapy, and 24 patients, Stage III of the CONV arm, underwent radiotherapy. Follow-up extended for seven years.
The study was performed on disease-free survival related to several prognostic factors: age, FIGO stage, tumor size, grading, parametrial involvement, lymph node status and surgical margins. Recurrence of disease occurred in 49 (32.1%) patients of the NACT arm (n = 153) and in 39 (37.1%). patients of the CONV arm (n = 105). Statistically significant differences in the recurrence of the disease were related to FIGO stage (p < 003), grading (p < .05), parametrial involvement (p < .002) lymph node status (p < .0001) and tumor size (p <.002). No statistical significance was related to age and surgical margins (p = ns). Disease-free and overall survival in the two groups were, respectively, 65.4% vs 53.5% (p = ns) and 70.4% 65.9% (p = ns).
European journal of gynaecological oncology 01/2010; 31(5):497-503. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to evaluate whether the addition of adjuvant chemotherapy will improve the outcomes of high-risk patients with Stage IB, IIA squamous cervical carcinoma with positive pelvic and/or aortic nodes.
127 patients with Stage IB and IIA cervical carcinoma treated with radical hysterectomy and systematic pelvic/aortic lymphadenectomy (RS) and who had lymph node involvement, confirmed at the final histological examination were enrolled from January 1987 to December 2001. All the patients received three cycles of adjuvant chemotherapy (AC) with cisplatin, bleomycin and vinblastine. The median patient age was 47.3. Seventy-seven patients had FIGO Stage IB1, 26 IB2 and 24 IIA. The results were compared with those obtained from a group of 136 patients with comparable age, stage and lymph node involvement, on whom radical surgery, systematic pelvic/aortic lymphadenectomy (RS) and adjuvant radiotherapy (RT) was performed on period 1971-1984. The followup period ranged from 7-13 years.
Overall survival rate of the two groups (RS+AC) vs (RS+RT) at seven years was 69.3% and 59.5%, respectively (chi2 = 2.70; p = .10). Progression-free survival was 59.8% vs 50.0% (chi2 = 2.56; p = .10 ns). The best results were however obtained with the common iliac and over two lymph node metastases.
Adjuvant chemotherapy in high-risk patients for lymph node positivity did not produce statistically significant results in terms of overall and disease-free survival vs adjuvant radiotherapy; however, a group of these patients, approximately 10%, could receive benefit from the treatment.
European journal of gynaecological oncology 01/2010; 31(5):545-50. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To compare outpatient endometrial sampling cytology with conventional biopsy in postmenopausal women with abnormal uterine bleeding and/or abnormal endometrial thickness at ultrasound.
Between December 2003 and December 2009 a group of 1,056 postmenopausal women was referred to the Department of Gynecological Sciences, Perinatology an Child Health II Faculty of Medicine, University of Rome, S.Andrea Hospital. Four hundred and eighty-two patients (45.6%) had abnormal uterine bleeding and 602 (57.0%) showed an endometrial thickness > 5 mm at ultrasound. Patients on hormonal therapy (n = 194) including hormonal replacement therapy (HRT) or tamoxifen (TMX), were enrolled in the study. Endometrial cytologic sampling was performed using a brush device (EBC) while endometrial histological sampling was retrieved using a Novak curette. Histologic evaluation showed: a) malignant neoplasia b) atypical hyperplasia c) benign pathology d) normal or atrophic endometrium. The following points were investigated: a) failure in performing a procedure for cervical stenosis or pelvic pain; b) nondiagnostic specimens; c) diagnostic accuracy.
Evidence in score pain differences between brush and curette endometrial samples were observed: 50% of patients undergoing brush cytology had lower pain scores (chi-square = 288.33; p = .001), whereas 60% of patients undergoing endometrial biopsy had higher pain scores (chi-square = 264.84; p = .001). The failure rate in performing procedures was 8.0% vs 4.1%, and the results were statistically significant on the McNemar test, respectively p = .01 and p = .001. A nondiagnostic specimen was obtained in 3.9% of cases by EBC, and 10.3% of cases by the Novak curette (p = .001). Cytological evaluation had a sensitivity of 100%, specificity of 99%, positive and negative predictive value of 97% and 100% for diagnosing malignant neoplasia. Cytology had high diagnostic accuracy for atypical hyperplasia: sensitivity 100%, specificity 99%, positive and negative predictive value 83% and 100%, respectively.
EBC is a reliable, well tolerated outpatient diagnostic tool for endometrial sampling in detecting early-stage cancer in postmenopausal patients at high risk for endometrial cancer.
European journal of gynaecological oncology 01/2010; 31(6):621-6. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To compare pregnancy rates after laparotomic microsurgical or laparoscopic distal tuboplasty.
Two hundred and twenty-four women with infertility due to distal tubal occlusion were randomized to be treated with either laparotomy or laparoscopy from 1987 to 2001 at the Institute of Gynaecology and Obstetrics, University of Rome, "La Sapienza".
The results were evaluated taking into account the type of surgical approach, the severity of tubal damage and of adhesions. After a 24-month follow-up period, the overall pregnancy rate obtained with microsurgery was 43.7%, of which 33.3% were term pregnancies, 5.0% abortions, and 5.0% ectopic pregnancies. After laparoscopy, the overall pregnancy rate was 41.6%, of which 29.1% were term pregnancies, 8.3% abortions and 3.9% ectopic pregnancies. No significant differences was observed between the two groups in terms of fertility rate (chi-square 0.016, p = 0.9003).
Laparotomy plus microsurgery and laparoscopy were equally effective in restoring fertility in women with comparable tubal damage. The severity of the damage is a critical factor for the results.
[Show abstract][Hide abstract] ABSTRACT: The aim of this retrospective study was to detect endometrial lesions in tamoxifen breast cancer users (menopausal state related). The meaning of genital bleeding during the treatment and the actual incidence of benign and malignant pathology of the endometrium related to length of treatment was also evaluated. Tamoxifen (TMX) is a nonsteroidal triphenylene derivate with clear antiestrogenic properties on the breast which is used as adjuvant treatment for breast cancer; potential adverse effects include endometrial lesions. Three hundred and sixty-six breast cancer patients were enrolled in this study; 292 patients were treated with 20 mg/daily of TMX as adjuvant therapy and the remaining 74 did not receive therapy. All patients were subdivided in premenopausal and postmenopausal, asymptomatic and symptomatic groups. All patients underwent ultrasound scans (to examine endometrial thickness) and hysteroscopic examinations before treatment and after one, three and five years. Endometrial biopsy under direct hysteroscopic vision was systematically performed. The pathological histology reports were classified under polyps, simple hyperplasia, complex hyperplasia, atypical hyperplasia, and carcinoma. A higher incidence of endometrial pathology was found only in symptomatic postmenopausal TMX treated patients (27.2% vs 19.5%) between the third and fifth year of treatment.
European journal of gynaecological oncology 02/2005; 26(1):99-102. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Postmenopausal HRT use is associated with an increase of mammographic density and reduction of sensitivity and specificity of mammography results and an increase of false-positive and false-negative outcomes. The increased density does not allow a good evaluation of the exam. Mammographic density is an independent risk factor for breast cancer, but the link between changes in breast density and difference in breast cancer risk, remain uncertain. On the other hand, today specific guidelines and protocols to optimize the screening of neoplastic breast pathology in HRT users do not exist and it is unknown if short-term suspension of therapy improves mammographic sensitivity. More information is required to define this important risk factor.
European journal of gynaecological oncology 02/2005; 26(5):485-90. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the effectiveness of hysteroscopic myomectomy in the treatment of symptomatic submucous leiomyomas and long-term outcomes.
A total of 107 patients with abnormal uterine bleeding (n = 84) and/or infertility (n = 23) were submitted to hysteroscopic resection. Main outcome measures: control of menorrhagia and reproductive outcome.
Abnormal uterine bleeding was controlled in 68 out of 84 patients with one procedure; 15 needed a second procedure for incomplete resection. Five patients had menorrhagic pathology relapse. Among 23 patients with associated infertility pregnancy was achieved in eight cases, seven went to term and one miscarried; one patient needed a second procedure. The mean follow-up was 36 months (24-60). Three patients were lost at follow-up.
Transcervical hysteroscopic resection of submucous myomas is effective for control of abnormal uterine bleeding. Further studies are needed to define the value of such procedure in the treatment of infertility. Short and long-term results are strictly correlated to the possibility of obtaining a complete resection, which is conditioned by degree (0, 1, 2) and number of myomas.
[Show abstract][Hide abstract] ABSTRACT: To evaluate the role of hormonal replacement therapy (HRT) in determining: a) abnormal uterine bleeding (AUB); b) increased endometrial thickness at transvaginal sonography (TVS); c) the correct indication for outpatient hysteroscopy (HS) and biopsy in diagnosing intrauterine pathology.
Between April 1991 and April 2001 a group of 3,400 postmenopausal women was referred to the Department of Obstetrics and Gynecology of Rome University "La Sapienza"; 16.7% of them had received HRT. 587 out of the 3,400 women were recruited for a comparative study, including four groups. To assess statistical significance of HRT in determining AUB, and/or endometrial thickness related to malignant disease the chi-square test was used; p < 0.05 was considered significant. Histology was considered the true result (control).
An increase in the endometrial thickness occurred significantly more often in women on HRT (p < 0.03); as well as the percentage of AUB (p < 0.0001). No difference in the incidence of endometrial adenocarcinoma was reported between the HRT and the non HRT groups.
In postmenopausal women using HRT we can confirm that a higher incidence of signs (AUB, endometrial thickness > or = 5 mm) does not coincide with a higher incidence of malignant pathology. The data obtained from the recruited patients was arranged and evaluated by the most suitable methods for screening endometrial adenocarcinoma. According to our experience, we believe a cut-off point of 8 mm to be significant (p < 0.001) to perform an hysteroscopy and biopsy except for asymptomatic patients on HRT.
European journal of gynaecological oncology 02/2003; 24(6):507-12. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this clinical study was to evaluate the relationship of tamoxifen and the risk factors of cardiovascular disease in hysterectomised women.
Between 1992 and 1998, 93 women were recruited for a prospective study with follow-up at 0, 12 and 24 months. All women had an increased risk of breast cancer and they were hysterectomised and ovariectomised for a benign pathology. They were divided according to the following categories: Group A was constituted of 26 (28%) symptomatic patients (hot flushes, depression) who had received tamoxifen and oral conjugated estrogens. Group B was constituted of 27 (29%) symptomatic patients who had received tamoxifen and transdermal 17B-estradiol. Group C was constitued of 19 (21%) asymptomatic patients who had received only tamoxifen. Group D (control) was constitued of 21 (22%) asymptomatic patients who had not received any therapy. A venous blood sample for total cholesterol levels (T-C), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), triglycerides (TRG), fibrinogen (FBR), platelets (PLT) and antithrombin III (AT III) was taken during follow-up. ANOVA (repeated measures) was used to assess statistical significance: p<0.05 was considered significant (95% CI).
The patients who received tamoxifen with or without estrogen replacement therapy showed after 24 months, a reduction of T-C, LDL-C and FBR (p<0.01); the HDL-C levels did not vary significantly compared to the control group (p=NS); the 26 patients of group A showed an increase of HDL-C (p<0.02). We reported an increase of TRG in the patients of group A and C (p<0.05); on the contrary, we obtained a significant reduction of TRG (p<0.01) in the patients who received tamoxifen and transdermal 17B-estradiol (group B). There was no interaction on plateled count (p=NS).
These results suggest the administration of tamoxifen in hysterectomised women with a high risk of breast cancer and without climateric symptoms. In these patients, tamoxifen could reduce coronary heart disease and incidence of breast cancer. The symptomatic patients are suggested to receive tamoxifen and transdermal 17B-estradiol because of the better effects on lipid metabolism.
[Show abstract][Hide abstract] ABSTRACT: A detailed operative procedure of laparoscopic radical hysterectomy (type III) with pelvic and aortic lymphadenectomy after neoadjuvant chemoterapy in treatment of Stage IIb cervical cancer is described.
A 50-year-old patient with Stage IIb squamous cell carcinoma of the uterine cervix, who initially was not surgically resectable, received three courses of neoadjuvant chemotherapy that included ifosfamide 5 g/m2, cisplatin 50 mg/m2 and paclitaxel 175 mg/m2 (TIP). Following a partial clinical response to chemotherapy, the patient underwent laparoscopic type III radical hysterectomy with bilateral salpingo-oophorectomy and pelvic and paraaortic lymphadenectomy. The surgical procedure lasted 250 minutes. Blood loss was 310 ml. The patient was discharged on postoperative day 4. The mean length of the resected parametria and paracolpia was 4.1 cm and 2.0 cm, respectively. The number of dissected lymph nodes was 48:29 pelvic and 19 paraaortic nodes. No major intraoperative or postoperative complications occurred. The patient also underwent adjuvant radiation therapy. Follow-up was performed at six months so far.
This experience suggests that such a surgical procedure is safe. Laparoscopic radical hysterectomy potentially allows for decreased perioperative morbidity and blood loss, faster recovery and better cosmetic results. Large studies with long term follow-up are needed to confirm that this approach may be proposed as an alternative to conventional surgery.
European journal of gynaecological oncology 02/2003; 24(5):393-7. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: to verify the efficacy of adjuvant therapy in the prevention of neoplastic recurrence in patients at high risk for lymph-node involvement on surgical examination.
72 patients, suffering from squamous cell cervical carcinoma Stage IB-IIB (FIGO) who underwent radical hysterectomy with lymph-node involvement confirmed at the final histological examination, were enrolled. All the patients were treated with adjuvant chemotherapy (AC), which included cisplatin, bleomycin and vinblastine, and were followed for a minimum period of six years. The results were compared with those obtained with a historical group of 78 patients, with comparable age, stage and lymph-node involvement, on whom only radical surgery (RS) was performed.
the average total survival rate of the two groups (RS + AC vs RS) at five years was 63.9% and 55.1%, respectively (chi2 = 1.191; p = NS). The disease-free interval was 55.6% vs 46.2% (chi2 = 1.324; p = NS). The best results were obtained in cases where the common iliac lymph-nodes were affected, with the highest survival rate of 16.9% in the RS+AC group, out of a total of 25 cases.
adoption of adjuvant chemotherapy in patients at high risk for lymph-node positivity did not produce statistically significant results in terms of overall and disease-free survival; however, a small number of these patients, approximately 9%, could receive benefit from the treatment.
European journal of gynaecological oncology 02/2003; 24(1):33-40. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: to verify whether a regimen of preventive chemotherapy in the treatment of cervical carcinoma allows surgical treatment in a larger number of patients and whether cases treated with this combined neoadjuvant polychemotherapy/surgery regimen improves overall and disease-free survival rates. Design: prospective randomized clinical study. Setting: Department of Gynaecology and Obstetrics, University of Rome "La Sapienza".
192 patients suffering from squamous cell carcinoma of the uterine cervix in Stages Ib-IIb were randomized to one of the following treatments: three courses of neoadjuvant chemotherapy with cisplatin, vincristine, bleomycin (NACT arm; n = 106); conventional surgery or radiotherapy alone (CO arm; n = 86). One hundred and fifty-six patients in Stage Ib-IIb (n = 86, NACT arm and n = 70, CO arm) and 16 patients in Stage III (NACT arm) who proved to be sensitive to the neoadjuvant chemotherapy, underwent radical hysterectomy. Four Stage III patients not sensitive to chemotherapy and 16 patients, Stage III, of the CO arm underwent radiotherapy.
the 5-year overall survival rates for the NACT and CO arm, respectively, were 78.6% and 73.2% in Stages Ib-IIa (p = NS), 68.7% and 64.3% in Stage IIb (p = NS). A 5-year disease-free survival rate for the NACT arm and CO arm, respectively, of 77.1% and 64.3% in Stages Ib-IIa (p < .05), 56.2% and 57.1% in Stage IIb (p = NS) was found.
the responsiveness of cervical cancer to neoadjuvant chemotherapy allows surgical treatment in a larger number of patients and results in longer overall and disease-free survival.
European journal of gynaecological oncology 01/2003; 24(1):51-9. · 0.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose: To evaluate the feasibility to perform laparo scopically assisted vaginal hysterectony in patients with uterine fibroids.
Patients and Methods : LAVH Gasless was carried out on 31 patients with uterine fibroids. Uterine weight ranged of 420-800 gr.
Results: There were 2 laparotomy conversion (6%) for uterus 800 gr; median operating time was 79+/- 18 minutes(range 75-89); the average haemoglobin drop was 1.7+/- 0.9 g/dl; the mean in postoperative stay was 3.7 +/-0.7 days (range 3-5). Febrile morbidity > 38°C were found in 3 cases.
Conclusion : Laparoscopic assistance has advantages in performing transection of infundibolo-pelvic ligaments in vaginal steps and in controlling post-operative blood loss
[Show abstract][Hide abstract] ABSTRACT: To evaluate the feasibility to perform laparoscopically assisted vaginal hysterectomy in patients who were not suitable for vaginal hysterectomy.
LAVH Gasless was carried out on 31 patients with uterine fibroids. Uterine weight ranged of 420-800 gr.
There were 2 laparotomy conversion (6%) for uterus 800 gr; median operating time was 79 +/- 18 minutes (range 75-89); the average haemoglobin drop was 1.7 +/- 0.9 g/dl; the mean in postoperative stay was 3.7 +/- 0.7 days (range 3-5). Febrile morbidity > 38 degrees C were found in 3 cases.
Laparoscopic assistance has advantages in performing transection of round and infundibolo-pelvic ligaments in vaginal steps and in controlling post-operative blood loss.
La Clinica terapeutica 01/2003; 154(3):163-5. · 0.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aims of this study were the effects of copper intrauterine device (Cu-IUD) compared to progesterone (PRG-IUS) or levonorgestrel releasing intrauterine system (LNg-IUS) on menstrual bleeding, menorrhagia and dysfunctional uterine bleeding. The authors evaluated the effect of copper surface area on uterine bleeding.
Between March 1992 and November 1999, 223 women, referred to I Institute of Obstetrics and Gynaecology University of Rome, were recruited in a prospective study with follow up at 3, 6 and 12 months to evaluate the incidence of endometrial pathology. The study includes 38 fertile women with regular menstruations and without intrauterine devices, as control group, and 185 patients with intrauterine devices, divides as follows: - 117 copper-releasing intrauterine devices: 30 with a copper (Cu) surface area =200 mm2, releasing 45 microgram Cu/24h (Nova T (R)); 27 with a copper surface area =250 mm2, releasing 50 microgram Cu/24h (Multiload 250 (R)); 25 with a copper surface area =375 mm2, releasing 65 microgram Cu/24h (Multiload 375 (R)); 20 with a copper surface area =384 mm2, releasing 100 microgram Cu/24h (No Gravid M (R)); 15 with a copper surface area =440 mm2, releasing 120 microgram Cu/24h (No Gravid 0,5 (R)). - 68 progesterone/levonorgestrel-releasing intrauterine devices: 40 progesterone-releasing intrauterine systems (Progestasert(R)); 28 levonorgestrel-releasing intrauterine systems 20 mg/24h (Mirena (R)). A total of 211 subjects had data that were valid for analysis: 12 women out of 223 (5,4%) were excluded from the prospective study lost to follow-up. A venous blood sample for serum ferritin (mg/l), iron (mg/dl), hemoglobin (g/dl), hematocrit (%), blood cell count, MCHC and MCV was taken during follow-up.
PRG or LNg-IUSs determined a significant reduction in menstrual blood loss and in irregular bleeding by gradually reducing endometrial fitness and vascularisation. Serum ferritin significantly increased in women inserted with LNg- IUSs already after 6 months (26+/-22 e 28+/-14 microgram/l versus 32.5+/-19 e 34.5+/-25 microgram/l). Hemoglobin significantly increased (p>0.05) 6 months after insertion. On the contrary this did not occur with the insertion of Cu-IUDs. We observed that the increased amount of copper, released by IUD, causes increasing of bleeding.
The LNg-IUS is a new contraceptive method combining the advantages of both hormonal and intrauterine contraception. In addition, it can be considered an alternative method in the treatment of menorrhagia and dysfunctional uterine bleeding. On the contrary, in women inserted with Cu-IUDs, the main reason of menorrhagia probably is due both to the shape of device and to copper surface area.