[Use of Misoprostol for medical abortion: a trial of the acceptability for home use]. / Enquête d'acceptabilité du misoprostol à domicile pour interruption volontaire de grossesse par méthode médicamenteuse.

OBJECTIVE: The object of this trial was to appreciate the acceptability of Misoprostol home use in medical abortion. PATIENTS AND METHOD: From 1 January 2001 to 28 February 2002, 120 voluntary patients were included in the study of medical voluntary pregnancy interruption with Misoprostol at home, and 289 patients were using the protocol "Misoprostol at hospital". RESULTS: The method was well tolerated by all patients. DISCUSSION AND CONCLUSION: The protocol "Misoprostol at home" is accepted under certain conditions: strict criteria selection, strict rules of security, good counseling of patients, and finally the availability at the telephone of the gynecologist to respond to any eventuality.

[Hysterosonography]. / Hystérosonographie.

Hysterosonography, which consists in the injection of some cc of saline in the uterine cavity during sonography, allows an exploration of the uterine cavity and of the endometrium. Accuracy of hysterosonography is similar to that of office hysteroscopy. Hysterosonography distinguishes normal cavities from pathologic ones, endometrial atrophy from mucosal anomalies, polyps from myomas. Conversely, endometrial biopsy is still necessary for diagnosis of hyperplasia or cancer. Hysterosonography can also be proposed for first trimester bleedings, trophoblast retention or ectopic pregnancy. In the near future it could be applied to therapeutic goals such as sonographic section of polyps.

Impact of pneumoperitoneum on tumor growth.

AIM OF THE STUDY: To compare intraperitoneal tumor growth after CO2 laparoscopy (L), gasless laparoscopy (GL), midline laparotomy (ML), and general anesthesia (GA) as a control. MATERIALS AND METHODS: A prospective randomized trial was carried out in nude rats. A carcinomatosis was obtained by intraperitoneal injection of either one of the two human ovarian cancer cell lines IGR-OV1 or NIH:OVCAR-3. Rats secondly underwent randomly different kind of procedures: CO2 L (8 mmHg, 60 min), GL (traction by a balloon for 60 min), ML (bowel removed and let on a mesh for 60 min), or GA. The rats were finally killed 10 or 35 days after surgery (respectively in IGR-OV1, or NIH:OVCAR-3 models). Tumor growth was assessed by the weight of the omental metastasis and MIB1 immunostaining. Peritoneal dissemination as well as abdominal wall metastases were assessed by pathological examination. Statistical analysis used the chi-square test (or Fisher exact test) and Bonferroni method for multiple comparison between groups. RESULTS: Fifteen rats were included in each group. Mean omental weight was significantly increased after surgery (3.1 to 5.6 g), when compared to control (2.4 g), but no significant difference was recorded between the three surgical accesses. MIB1 immunostaining was poor in the PNP group (37%), whereas it was higher after midline laparotomy (51%), but the difference was not significant (p = 0.07). Similarly, no significant variation was recorded in the NIH:OVCAR-3 model for omental weight or MIB1 staining. CO2 pneumoperitoneum significantly increased right diaphragmatic dome involvement in the NIH:OVCAR-3 model. Abdominal wall metastases were significantly more frequent after surgery when compared to the control group, but no significant difference could be demonstrated between surgical groups in each model. CONCLUSION: In these solid tumor models, CO2 pneumoperitoneum had no deleterious effect on tumor growth when compared to gasless laparoscopy or midline laparotomy.

Description of two new human ovarian carcinoma models in nude rats suitable for laparoscopic experimentation.

BACKGROUND: Experimental laparoscopic trials require relevant models of ovarian carcinomatosis. METHODS: Female nude rats were inoculated intraperitoneally either with the IGR-OV1 or the NIH:OVCAR-3 human adenocarcinoma cell lines. Serial clinical checks and sacrifices were used to evaluate the rates of tumor take, survival, and patterns of tumor spread. Finally, laparoscopies with various pneumoperitoneum pressures were performed to verify the "surgical" relevancy of out models. The learning curve was measured. RESULTS: The best results were obtained when twenty-seven 106 IGR-OV1 cells and thirty-six 106 NIH:OVCAR-3 cells were injected in 28-day-old rats. The IGR-OV1 model provided a mean survival of 17.8 days (range, 13-22 days), with a high take rate (94%). The NIH:OVCAR-3 model resulted in a longer mean survival (59 days; range, 49-77) and also a high take rate (83%). The two models differed in their patterns of tumor spread: solid bulky omental metastasis having a diffuse microscopic peritoneal carcinomatosis with the IGR-OV1 line (the weight of the omental cake correlated significantly with the stage of development) and diffuse macroscopic peritoneal carcinomatosis having no large solid tumor, but visceral and paraaortic metastases, with the NIH:OVCAR-3 line. In both models, CA125 was high. Anesthesia could be performed and repeated in healthy and tumor-bearing rats. Laparoscopy was feasible, with pneumoperitoneum pressures as high as 8 mmHg lasting 1 h. Laparoscopy provided a reliable evaluation of the tumor spread into the peritoneal cavity. The plateau of the learning curve was soon obtained for take rate and survival after laparoscopy. CONCLUSION: We report two new human ovarian carcinoma xenografts in nude rats suitable for laparoscopy. The IGR-OV1 model mimics an advanced stage of the disease, and the NIH:OVCAR-3 model presents an earlier stage. These two models appear useful for experiments involving laparoscopy.

Impact of pneumoperitoneum on visceral metastasis rate and survival. Results in two ovarian cancer models in rats.

OBJECTIVE: To compare the impact of CO2 laparoscopy, gasless laparoscopy, and midline laparotomy on the development of distant metastases and on survival in two ovarian carcinoma models. DESIGN: A prospective randomised study in rats. MATERIAL: and methods Two ovarian cancer xenografts were obtained by intraperitoneal injection of IGR-OV1 or NIH-OVCAR-3 cells. Experimental surgical procedures were performed on day 7 (IGR-OVI model) or day 14 (NIH: OVCAR-3 model) after intraperitoneal injection: CO2 laparoscopy (pneumoperitoneum (PNP) with unheated CO2 at a pressure of 8 mmHg for 1 hour); gasless laparoscopy (consisting in abdominal wall expansion by a balloon for 1 hour); midline laparoscopy (consisting in bowel exteriorisation on a mesh for one hour following xyphopubic laparotomy). The control group underwent general anaesthesia alone. The animals were killed by CO2 inhalation as soon as they became moribund. MAIN OUTCOME MEASURES: Pathological examination was carried out on the liver, lungs and pleura as well as the retroperitoneal nodes. Survival was determined from the time of surgery to the sacrifice of the animal. Statistical analysis used ANOVA, Fisher exact test, Bonferonni method and the log-rank test. RESULTS: In the IGR-OV1 model, distant metastases were rare, and were not promoted by CO2 laparoscopy. With the NIH: OVCAR-3 model, pleural, pulmonary and para-aortic metastases were not enhanced by CO2 PNP when compared with other approaches. Conversely, midline laparotomy and laparoscopy significantly increased liver involvement when compared with gasless laparoscopy (P = 0.04 and P = 0.008). Survival was comparable no matter what kind of surgery had been performed in the IGR-OV1 model (P = 0.7) or in the NIH: OVCAR-3 model (P = 0.5). CONCLUSIONS: CO2 laparoscopy had a minor impact on distant and nodal metastases in the two models. Similarly, survival was similar for all surgical groups.

Hospital resources used for ectopic pregnancy treatment by laparoscopy and methotrexate.

OBJECTIVE: To compare resources used in the medical and laparoscopic treatment of unruptured ectopic pregnancy. METHODS: We prospectively recorded all the medical resources required in the treatment of unruptured ectopic pregnancy. The study period ranged from January 1, 1995 to June 30, 1998. Single-dose intramuscular methotrexate injections were administered in 55 women (group I). This therapeutic option was provided on an outpatient basis in small EP (beta-HCG level < 5000 IU/L and hematosalpinx diameter < 3 cm). Serial clinical controls and biologic tests were performed until bHCG became negative. Forty women underwent a laparoscopic salpingostomy because they refused the methotrexate regimen or had "social" contra-indications (ie, predictable difficulties in the follow-up) (group II). Twenty-one patients underwent conservative laparoscopic treatment because of "medical" contraindications to methotrexate (group III). We recorded the resources used with the outpatient and inpatient treatment in each group (methotrexate consumption, operating room acts, length of hospital stay, clinical examinations, biological tests, and sonograms during the follow-up). RESULTS: We observed similar cure rates in each group, but it took significantly longer for beta-HCG to become negative in group 1. However, hospitalization was significantly less often required, and the length of hospital stay was shorter in this group. But length of follow-up, number of office visits, biological tests, sonograms, and subsequent readmissions were significantly more frequent after methotrexate. Despite more severe clinical presentations for patients in group III, we didn't find any significant differences in the hospital resources used in this group in comparison with those used in group II. CONCLUSIONS: The outpatient methotrexate option may result in low consumption of resources for a hospital because most of the follow-up can be performed by city practitioners and laboratories. For the laparoscopic option, efforts should be made to reduce the postoperative hospital stay.

Laparoscopy in patients with prior surgery: results of the blind approach.

BACKGROUND AND OBJECTIVES: To compare the complication rate due to blind access laparoscopy between patients with or without a prior history of laparotomy. METHODS: We examined a prospective record of data on laparoscopic surgeries performed from 1992 to 1998. Only cases in which the Veress needle and the first trocar were inserted through the umbilicus were included in this study. Results issued from patients without previous abdominal surgery (Group I) were compared with those arising from women with prior laparotomy (Group II). A statistical analysis was performed using the Chi-square test or Fisher exact test when appropriate. RESULTS: One thousand thirty-three laparoscopies were carried out during the study period, 881 of which began with a blind access through the umbilicus. Two hundred two women (19.3%) had an history of abdominal or pelvic surgery. Eight hundred forty-two patients were included in Group I and 39 in Group II. Failure to penetrate into the peritoneal cavity occurred significantly more frequently in Group II (4/39) than in Group I (1/842, P < 0.0001). The insertion of the Veress needle gave rise to 2 complications in Group I and 0 in Group II (P = 1.0). Transumbilical trocar insertion gave rise to 1 complication in each group (1/841 vs. 1/35, P = 0.11). When all events were considered, incidents or accidents were significantly more frequent in Group II (5/39) than in Group I (4/842)(P < 0.0001). CONCLUSIONS: We recorded a higher rate of incidents/complications due to the Veress needle and trocar insertion in patients with a previous history of laparotomy. An adapted approach should be recommended for these patients.

Saline contrast sonohysterography in the preoperative assessment of benign intrauterine disorders.

OBJECTIVES: To assess the value of saline contrast sonohysterography (SCSH) in the preoperative evaluation of benign intrauterine lesions. DESIGN: Patients presenting with abnormal bleeding related to benign uterine pathologies and scheduled for surgical treatment were prospectively enrolled in a study conducted between 1 January 1996 and 31 December 1997. SCSH was first carried out with the intention of establishing further surgical management (hysterectomy or hysteroscopy). The end point of the study was to compare the surgical option ultimately carried out with the one decided after SCSH. In addition, size and location of intrauterine lesions determined by SCSH were compared with those issued from surgical records. Similarly, pathologic results were juxtaposed to SCSH diagnosis. Statistical analysis used non-parametric and correlation tests. RESULTS: Two hundred and thirty-three patients were included in the study, 39.5% of whom were postmenopausal. SCSH was consistently effective in the choice of the best surgical method, because no hysterectomy was required when an operative hysteroscopy was indicated on SCSH data. Similarly, only one patient treated by hysterectomy (5.8%) could have undergone a more conservative approach. But this patient had a genital prolapse, and thus hysterectomy was a part of the treatment. SCSH correlated well with surgery for the location and size of intrauterine lesions (P < 0.001). SCSH was accurate in the diagnosis of polyps and submucous myomas (sensitivity 85.7%, specificity 95.4%). CONCLUSIONS: SCSH appears an important tool for preoperative assessment of benign intrauterine pathologies. It should be used in the selection of patients that should be scheduled for an operative hysteroscopy.

Perioperative morbidity of gynecological laparoscopy. A prospective monocenter observational study.

BACKGROUND: To study the morbidity rate of gynecological laparoscopy and to the most influential variables. METHODS: We conducted a prospective observational study from January 1st 1992 to December 31st 1998 in a single tertiary care center. It concerned patients who underwent gynecological laparoscopic surgery performed by seniors and residents. We have prospectively recorded patients characteristics, indications for laparoscopy, leading diagnosis, main operative procedures, post-operative course, surgical and anesthetic incidents and accidents. Complications were defined as any event that would modify the usual course of laparoscopy or of the post-operative period. RESULTS: One thousand and thirty-three laparoscopies were included. 80.1% of the procedures were major or advanced laparoscopies. The overall complication rate was 3%, with a laparotomy rate of 1.2%. About half of those complications (54.8%) occurred during the installation of laparoscopy. Veress needle and first trocar insertion accounted for 23.5% of those accidents (0.3% of the procedures) and suprapubic trocar insertion for 76.5%. Hemorrhages constituted almost all of the complications occurring during the operative stage (80%). The risk increased with the level of surgery and decreased with surgeon's experience. Prior abdominal surgery had no significant effect on the overall morbidity rate. Post-operative and anesthetic complications were rare. The overall complication rate as well as the laparotomy rate were stable all along the course of the study. CONCLUSIONS: Complication rate of gynecological laparoscopy is not negligible. Efforts should be made to lower the complications induced by the installation of laparoscopy, especially for secondary trocars.

Direct cost of single dose methotrexate for unruptured ectopic pregnancy. Prospective comparison with laparoscopy.

OBJECTIVES: to compare the direct cost of single dose methotrexate (MTX) and laparoscopy in the treatment of unruptured ectopic pregnancy (unruptured EP). STUDY DESIGN: A prospective nonrandomized study. Thirty-two women received intramuscular MTX (1 mg/kg) on an out-patient basis when they fulfilled the following requirements: human chorionic gonadotropin (hCG) level <5000 IU/l, hematosalpinx diameter <3 cm and peritoneal fluid <100 cc. Follow-up consisted of clinical controls and hCG assays. Twenty-seven women eligible for MTX therapy according to the above conditions underwent laparoscopic salpingectomy because some of them refused the therapy while others had contraindications to MTX. We recorded all the medical expenses related to the out-patient and in-patient management for the two treatment options. The cost was calculated according to the French General Nomenclature of Professional Acts and expressed in Euros. RESULTS: MTX resulted in a significantly lower mean direct cost in comparison with surgery (E 1145 vs. 2442, P=0.006) that was mainly due to shortened hospital stay (1.1 vs. 2.8 days, P=0.007). Conversely MTX required a significantly higher number of medical acts during the follow-up. Costs for MTX therapy were closely related to the length of hospitalization and to the duration of the follow-up. CONCLUSION: Single dose MTX provides significant cost-savings when compared to laparoscopy. Savings reach a peak for small unruptured EP because hospitalization is not required and the length of follow-up reduced.

[Complications of gynecological laparoscopy. Results of a prospective single center study]. / Complications de la coeliochirurgie gynécologique. Résultats d'une étude prospective unicentrique.

Gynaecological laparoscopy is associated with a patient morbidity rate. Half of the complications occur during the installation stage.

Anticoagulant therapy in pregnancy.

Anticoagulation during pregnancy should derive benefit from recent advances in anticoagulant therapy. Unfractionated heparin is at present the drug of choice for most of the indications of thromboprophylaxis as well as for acute venous thrombosis during pregnancy but it is likely that, in the near future, low molecular weight heparins will supercede this anticoagulant in many indications. One particular indication is mechanical heart valves that needs a high degree of anticoagulation. The anticoagulant of choice that carries the best efficacy-risk ratio in this situation seems to be oral anticoagulants. Pregnant women receiving anticoagulation should be considered as high-risk patients that should be managed in specialized centres. They are prone to bleeding complications that will mainly occur during delivery or in the postpartum period.

Effect of methotrexate on tubal epithelium. A report of three cases.

BACKGROUND: Tubal effects of methotrexate injections have been poorly reported. CASES: Three fallopian tubes were examined with light microscopy 9-13 months after tubal methotrexate injection (one case) and intramuscular methotrexate injection (two cases) given for the treatment of unruptured ectopic pregnancies. No evidence of tubal damage was found. CONCLUSION: These three cases confirm previous experimental and clinical data showing the absence of a direct adverse effect of methotrexate on the fallopian tubes in the treatment of ectopic pregnancy.

Morbidity in laparoscopic gynecological surgery: results of a prospective single-center study.

BACKGROUND: We set out to investigate prospectively the morbidity rate for gynecological laparoscopy patients at a tertiary care center. METHODS: We prospectively recorded data on 743 laparoscopic procedures performed between January 1, 1992 and December 31, 1996. The procedures included 36 diagnostic laparoscopies (4.8%), 115 laparoscopies carried out for minor surgical acts (15.4%), 523 for major surgical acts (70.4%), and 69 for advanced surgical acts (9. 4%). A total of 127 patients had a history of prior laparotomy (17%). All those procedures were performed by young senior surgeons. We defined a complication as an event that had modified the usual course of the procedure or of the postoperative period. For statistical analysis, we used the chi-squared test or Fisher's exact test. RESULTS: Complications occurred in 22 cases; the overall complication rate was 2.9% when all events were considered. One complication (injury of the left primitive iliac artery) was related to insertion of the Veress needle (0.13%). A total of 2,578 trocars were inserted, giving rise to 10 complications (1.3%). Three unintended laparotomies were required for bowel or bladder injuries (0.4%). Finally, the introduction of the laparoscope was responsible for 11 complications (1.4%); this figure represents 50% of all the complications of this series. Eight intraoperative complications (1%) occurred during the laparoscopic surgery (seven severe bleedings and one ureter injury, but no intestinal lesions); laparotomy was required in six of these cases. Three complications occurred during the postoperative stage: one granulomatous peritonitis after intraabdominal rupture of a dermoid cyst, one incisional hernia, and a fast-resolving cardiac arrhythmia. CONCLUSIONS: In our experience, operative gynecological laparoscopy is associated with an acceptable morbidity rate. Moreover, about half of the complications occur during the installation of the laparoscopic procedure, underscoring the usefulness of safety rules.

The long-term tolerability and efficacy of OESCLIM: results of a 1-year study.

OBJECTIVES: A 1-year, open-label, non-comparative study evaluated the long-term tolerability and acceptability of a new generation matrix patch in post menopausal women with estrogen deficiency. METHODS: Menopausal women (224) from 37 centres in five European countries received OESCLIM 50 microg/d (17-beta estradiol) for 3 months, titrated if necessary to either 25 or 100 microg/d for a further 9 months. Patients received either a continuous or discontinuous estradiol regimen with concomitant sequential progestogen (except hysterectomised patients). Skin tolerability was assessed by patient diaries and questionnaires. Global tolerability, efficacy, laboratory parameters and global acceptability were also monitored. RESULTS: Almost two-thirds of women did not experience any kind of skin reaction and only 4.3% of all applications (752/17,702) caused site reactions. Of these, the majority caused only slight or no discomfort (63.2%). Only 0.37% of total applications required patch removal; none required therapy. A low percentage of patients withdrew due to tolerability issues: 2.7% due to skin reactions; 7.5% due to hyperestrogenism. The mean number of hot flushes experienced by symptomatic women reduced by 91% from 4.0 at baseline to 0.4 after 2 months. Total cholesterol reduced by 3.9% and LDL cholesterol by 5.1%, with no increase in triglyceride levels. Investigators assessed treatment as effective in 96.8% of cases; well tolerated locally in 93.1% and well tolerated generally in 89.5%. At the end of this 1 year study, 79% of patients wished to continue therapy. CONCLUSION: OESCLIM is well tolerated locally and systemically in long-term therapy with a high proportion of patients wishing to continue therapy after 1 year.

[Microinvasive carcinoma uterine cervix. Which approach in 1998?]. / Cancer micro-invasif du col utérin. Quelle approche en 1998?

Numerous definitions of microinvasive carcinoma (MIC) have been proposed. The SGO takes into account the depth of stromal invasion and presence of capillary like space involvement (LVI). The Figo uses the lesion width and describes different substages according to the depth of stromal invasion. Two major prognostic factors can be identified in the literature: the depth of invasion and the presence of LVI. The lesion volume is probably more accurate than the depth of stromal invasion but cannot be measured in routine. Taking into account that a classification must be a guide for the evaluation of prognosis and treatment, the SGO definition seems more reliable. Pelvic lymph node metastasis rate and recurrence increase with these two factors. MIC with stromal invasion under 3 mm and without LVI have a little risk of parametrial and nodal involvement: with a high rate of survival. Conversely, MIC with invasion over 3.1 mm depth or LVI have a greater risk of spread beyond the cervix (1% versus 7.7%) and many authors now consider them as true invasive cancers. For lesion invading the stroma within 3 mm, the treatment can be limited to a standard hysterectomy with good results. Some authors have proposed more conservative therapy as conization. This procedure is interesting for young women willing to preserve their anatomy, fertility and sexual function. In selected cases, short term results are similar to those of hysterectomy but there is a lack of controlled studies with long term follow-up. Lesions over 3.1 mm with LVI should be treated as true invasive cancers. Intermediate cases should have a conservative therapy associated with a laparoscopic lymphadenectomy.