Assessment and comparison of intraoperative and postoperative pain associated with NovaSure and ThermaChoice endometrial ablation systems.

STUDY OBJECTIVE: To assess and compare intraoperative and postoperative pain associated with NovaSure impedance-controlled endometrial ablation system and ThermaChoice system. DESIGN: Prospective, international, multicenter, double-arm study (Canadian Task Force classification II-1). Setting. Academic medical centers and private offices. PATIENTS: Sixty-seven premenopausal women with menorrhagia. INTERVENTION: Endometrial ablation with either the NovaSure (37 women) or ThermaChoice (30) system. NovaSure-treated patients received no endometrial pretreatment; those treated with ThermaChoice received the recommended 3-minute suction dilatation and curettage. MEASUREMENTS AND MAIN RESULTS: Standard pain measurement instruments (visual analog scale, numeric rating scale) were used to assess intraoperative and postoperative pain. Serum levels of prostaglandin-F(2alpha) were measured before and 5, 30, and 60 minutes after the procedure. Patients treated with the NovaSure system reported statistically significantly lower intraoperative and postoperative pain than those treated with the ThermaChoice system (p <0.0001). Procedure time was statistically significantly shorter with the NovaSure system (p <0.0001). Prostaglandin-F(2alpha) values did not differ statistically between groups. CONCLUSION: The NovaSure system is associated with statistically significantly lower intraoperative and postoperative pain than ThermaChoice system, and endometrial ablation with NovaSure could become an office-based procedure.

Comparison of transvaginal ultrasound, hysteroscopy, and dilatation and curettage in the diagnosis of abnormal vaginal bleeding and intrauterine pathology in perimenopausal and postmenopausal women.

STUDY OBJECTIVE: To compare transvaginal ultrasound, hysteroscopy, and dilation and curettage (D&C) in the evaluation of women with perimenopausal and postmenopausal bleeding. DESIGN: Descriptive study (Canadian Task Force classification II-1). SETTING: Seven outpatient clinics. PATIENTS: One thousand two hundred eighty-six women. INTERVENTION: Transvaginal ultrasound, hysteroscopy, and D&C. MEASUREMENTS AND MAIN RESULTS: Of our patient population, 29 (2.26%) had a histologic diagnosis of endometrial carcinoma; in 2 of them (7.14%) endometrial thickness was 5 mm or less. In 10 women (34.5%), endometrial carcinoma was missed by hysteroscopy (sensitivity 65.52%, specificity 99.92%). Complication rate of D&C was 1.4%. CONCLUSION: In women with perimenopausal and postmenopausal bleeding neither transvaginal ultrasound nor hysteroscopy as a single diagnostic tool is suitable to rule out endometrial cancer.

Endometrial ablation by balloon coagulation.

Different techniques of global endometrial ablation have been developed during the last 5 years, starting with the introduction of the thermal and the electrocoagulation balloon up to the latest development of bipolar coagulation techniques. Balloon application has many advantages to traditional hysteroscopic laser or electrotechniques. No pre-operative hormonal treatment is required. The operation itself is easier to perform and there is no need for experience in operative hysteroscopy. The main advantage is the lack of a distention medium. Even anesthesiological high risk patients can be treated by balloon techniques without problems. Hysterectomy can be avoided more and more. Essential for global endometrial ablation, in my mind, is a diagnostic hysteroscopy best performed immediately prior to endometrial ablation. In this way, the uterine cavity is evaluated and complications can be avoided or detected early. This combination results in excellent outcome with the lowest complication rate.

[Laparoscopic therapy of interstitial tubal pregnancy]. / Laparoskopische Therapie einer interstitiellen Tubargravidität.

Interstitial pregnancy is life threatening and rarely operated laparoscopically. We report on the diagnostic and therapeutic endoscopic management using monopolar scissors, loop, suturing and bag harvesting.

Thermoregulated radiofrequency endometrial ablation.

OBJECTIVE: To test the hypothesis that treating dysfunctional uterine bleeding by automated application of electrothermal energy to the uterine cavity, with precise regional control, might yield results equivalent to those reported for hysteroscopically directed laser and electrosurgical endometrial ablations. MATERIALS AND METHODS: Patients with life style compromising menorrhagia, referred to six gynecologic surgical centers for hysterectomy or endometrial ablation, were admitted to the study if they had normal cervical cytology, a benign endometrial biopsy, no defined cause for their bleeding, and consented to participate in the evaluation of a newly developed Vesta DUB Treatment System. The device consists of a silicone-inflatable electrode carrier to be inserted into the uterine cavity and a controller to monitor and distribute current from a matched electrosurgical generator. Treatment involved a 3-minute or shorter warm-up period and a 4-minute treatment phase. RESULTS: Three- to 24-month follow-up data were available for 187 patients, with a mean follow-up of 14.8 months. The amenorrhea rate was 38%. Bleeding was reduced in 95% of patients. Actuarially, 88 +/- 3% of patients should expect to be free of menorrhagia, dissatisfaction, or need for a second procedure out to 24 months. CONCLUSIONS: The unique regional feed-back control offered by this system causes thorough, evenly distributed, thermal destruction 4-5 mm into the myometrium that reduces bleeding with durability equivalent to published reports of hysteroscopic endometrial ablation.

Transcostal Access with the Veress Needle in Women with Several Previous Surgeries

Establishing pneumoperitoneum using the classic umbilical port in women who have had several previous surgeries is risky, life threatening, and a diabolic challenge for the surgeon. Open laparoscopy is one alternative, with a risk factor for bowel injury of 0.5%. Since 1992 we have preferred the transcostal approach. A stab incision is made between the ninth and tenth ribs in the left medioclavicular line and a disposable Veress needle is pushed into the coelomic cavity. Passing the needle only in this area of strongly attached peritoneum, the typical needle click is heard and its intraabdominal position is confirmed by an insufflation pressure below 5 mm Hg. After insufflation of 0.5 L, percussion in the right hypochondric quadrant ensures correct distribution of the gas. A contraindication for this port is a prior splenectomy. No complications occurred in our series of 64 patients.

Endometrial ablation using a distensible multielectrode balloon.

The VestaBlate system uses a multielectrode intrauterine balloon as a device to create effective and safe endometrial ablation (EA). The surface of the distensible balloon is impregnated with thermistors and thin, platelike electrodes. It is designed to deliver low-power electroenergy to the endometrium. Unlike the resectoscope techniques that require nonelectrolytic fluids for uterine distention, moving electrodes at high power outputs, and other variables that are operator dependent, the VestaBlate is computer controlled using a standard type electrosurgical generator. A respiratory enzyme stain, nitroblue tetrazoleum, was used to determine the extent and depth of tissue necrosis to a myometrial depth of 2 to 4 mm with uniform destruction of tissue with power setting at 45 W for a 4-minute application of energy. Sixty-nine patients have been treated, with 45 followed for at least 3 to 9 months. The amenorrhea rate is 40%; the oligomenorhea-hypomenorrhea rate is 49%.

[Aspects of peritoneal fascia closure after surgical laparoscopy]. / Aspekte des Peritoneal-Faszienverschlusses nach operativer Laparoskopie.

Following laparoscopic surgery using trocar ports of 10 mm and more Richter's hernia and incarceration of bowel are reported. To prevent this wound closure of all layers is a must. Newly developed techniques are described. Fascia closure is accompanied by serious pain. Pain management is achieved by local anesthesia.

Gynecologic laparoscopy and hysteroscopy in a day clinic: trends and perspectives.

We have increased the performance of minimally invasive gynecologic surgery from about 15% to 20% of operations a year, especially hysteroscopies and laparoscopies, many of which are performed in a free-standing ambulatory unit. In 1992 our team performed 8057 outpatient operations, significantly more than in 1991. As the techniques are developed, the number of indications for these operations expands. By maintaining high standards, even with major endoscopic procedures, we have a very low complication rate.

[Experiences with 3120 outpatients sterilized by laparoscopic tubal bipolar coagulation (author's transl)]. / Erfahrungen mit 3120 klinisch-ambulanten laparoskopischen Tubensterilisationen.

3120 patients have been sterilized by laparoscopic tubal bipolar coagulation. The operations were performed in an outpatient procedure. 0.096% severe complications during surgery were caused. The pregnancy rate was 0.06%. Our experiences and results confirm the low risk outpatient way of laparoscopic sterilization as reported in Anglo-American literature.

PIP: 3120 patients were sterilized by laparoscopic tubal bipolar coagulation performed on an outpatient basis. A total of 0.96% of the cases developed severe complications and the pregnancy rate was 0.06%. Our experiences and results are in accordance with the low risks of laparoscopic sterilization on an outpatient basis reported in the Anglo-American literature. (author's)

[Prenatal diagnosis of a double fissure malformation (author's transl)]. / Pränatale Diagnostik einer Doppelspaltbildung.

By Sonography changes of the non-osseous parts of the fetal body are just as recognizable as any malformation of the skull and skeleton. We report about a severe case of double cleft formation. The prenatal diagnosis pre-determined our intranatal care and method of delivery.

A preliminary report about transcervical embryoscopy.

Transabdominal amniocentesis and occasionally fetoscopy are used as a means of early diagnosis of fetal damage or abnormality after the 14th week of pregnancy. For medical reasons a still earlier method of diagnosis is desirable. We report about the transcervical approach- using CO2-gas-hysteroscopy to visualize the amnion sac and its contents.

[Outpatient termination of pregnancy in the first trimester during paracervical blockade with Carticain (author's transl)]. / Der ambulante Schwangerschaftsabbruch im ersten Trimenon in Parazervikalblockade mit Carticain.

Sparing termination of pregnancy with a low incidence of complications, using the drainage method in local anaesthesia, can be effected on an outpatient basis. Carticain, which is a rapidacting anaesthetic with good analgesic effect, enables practically painless dilatation of the cervical channel with subsequent evacuation, when combined with good psychological guidance of the patient. When questioned postoperatively, practically all patients were in favor of local anaesthesia. Another positive aspect, in their opinion, was the fact that they could be discharged after brief hospitalization. Furthermore, treatment on an outpatient basis is cost-saving.

PIP: Termination of pregnancy using vacuum aspiration was performed on 112 outpatients using Carticain for paracervical blockade. A rapid-acting anesthetic with good analgesic effect, Carticain permitted nearly painless dilatation of the cervix to Hegar 9 or 11. Evacuation of the uterus generally required less than 1 minute. Patients who were without symptoms of complications 2 hours after the operation were released. Most patients favored local anesthesia because of the savings in hospitalization time and costs.

[A comparative study of the suction and customary curettage methods in the termination of pregnancy (author's transl)]. / Hysteroskopische Untersuchungen nach Aspirations-und instrumentelle Curettage für den Schwangerschaftsabbruch.

90 hysteroscopies using CO2 were performed to evaluate differences in effectiveness between the customary curettage and the suction methods in terminating pregnancy during the first trimenon. Following suction, the uterine cavity was nearly always thoroughly evacuated. Very seldom is there any residual tissue seen. On the contrary, the uterine cavity following termination by customary curettage was almost never completely evacuated. Very often rest tissue of decidua, usually chorionic, in some cases with villous structures, were found. Tissue remnants following termination by either method were removed by target biopsy or curettage and examined histologically. Having made the above observations and comparison, it must be concluded that the suction method is clearly the more advantageous. If applied correctly, it becomes unnecessary to perform curettage right after the suction.

PIP: Vacuum aspiration and instrumental curettage were compared with respect to completeness of uterine evacuation in 90 women. 54 patients had vacuum aspiration, 36 had curettage. Hysteroscopy using CO2 showed that the aspiration patients had less intrauterine bleeding, and pregnancy-related tissue was observed in only 6 of these patients. In the curettage patients, residual tissue was seen in 32 cases, and follow-up curettage or removal of remaining tissue was performed in 20 patients. No complications were observed in either group. Techniques and advantages of aspiration are discussed. It is clear that the suction method is to be preferred and if handled properly, curettage is unnecessary following suction.

[Physical and physiological principles of CO2 hysteroscopy (author's transl)]. / Physikalische und physiologische Grundlagen der CO2-Hysteroskopie

Various possibilities of developing the uterine cavity for hysteroscopy were presented together with their advantages and disadvantages. The authors consider CO2 gas insufflation to be the method of choice. The physical, physiological and technical principles and data of the procedure were discussed. The construction and function of the Hysteroflators 1000 S, a special gas insufflation apparatus for hysteroscopy were also discussed.

[Experimental and clinical investigations on the effects of carbon dioxide gas during hysteroscopy (author's transl)]. / Der Einfluss von CO2-Gas während der Hysteroskopie

The acute toxicity, lethal dosage and mechanical effects of carbon dioxide gas were studied in the waking dog by intravenous and intra-arterial insufflation. The threshold dosage for toxicity was 400 ml per minute in the dog. The important factor in the toxicity was not the total volume of carbon dioxide but the volume per unit of time. Metabolic acidosis was responsible for changes in the EKG, the heart rate and the respiratory rate. These findings are discussed in relationship to the usage of carbon dioxide gas for hysteroscopy in the human female. During carbon dioxide gas hysteroscopy blood gas analyses were done in 40 patients. 28 patients had a hysteroscopy under general anaesthesia and 12 patients under local anaesthesia. It was found that the volume of carbon dioxide used for the creation of a pneumometra in hysteroscopy has no side effect. The necessary gas flow is too small for toxic side effects or mechanical side effects such as a gas embolisation.