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Efficacy and safety of oral 17β-estradiol for the treatment of vasomotor symptoms in postmenopausal women
ENDOMETRIAL CRYOABLATION: PRELIMINARY STUDIES WITH A LOW-PRESSURE, CLOSED-LOOP FREEZING SYSTEM David L. Olive, MD, E. Pritts, MD, V. Parkash, MD, and R. Camp, MD Yale University Schoolof Medicine, New Haven, CT Study objective: To determine the safety and feasibility of endometrial cryoablation with a low-pressure, closed-loop freezing system-the Soprano Cryotherapy-system through in vitro studies with extirpated uteri and in vivo studies with hysterectomy patients. Methods: In vitro studies incorporated thermocouples to monitor serosal tissue temperatures and were placed at the ftmdus and at the left and right comua. Endometrial thermocouples were placed at the surface of the endometrium and at 5-mm increments to a depth of 20 mm. All specimens underwent a single freeze cycle in a 37°C water bath. Cryoprobe placement and ice ball formation were monitored using ultrasound guidance. In vivo studies incorporated thermocouples placed at the fundus, left and right comua, midcavity, and lower uterine segment. All specimens received the cryotherapy treatment prior to hysterectomy through an abdominal or laparoscopic approach. Cryoprobe placement and ice ball formation were monitored using ultrasound guidance. Pathologic evaluation using nitroblue tetrazolium staining and electron microscopy examined the tissue effects of cryoablation. Results: In vitro cryotherapy included six extirpated uteri specimens. Cryotherapy treatment revealed a 3-cm ice ball in less than 7 minutes, with -20°C isotherms at -8mm depth of penetration into tissue. Cryoprobe surface temperatures reached a nadir of -112°C at 150 seconds. There was no evidence of dangerous serosal temperatures in any specimen. In vivo study included 12 patients receiving cryotherapy just prior to undergoing a hysterectomy for benign indications. Freezing time was 7 minutes in the first 9 patients, and 5 minutes in the last 4 patients. The mean depth of tissue injury was 1.1 cm (range, 0.6-1.8 cm) and included the entire endometrial thickness in all patients extending well into the myometrium. The lowest mean serosal temperature reached 20°C (range, 4”C-32°C). The lowest temperature of 4°C occurred in a patient receiving a ‘/-minute freezing treatment. Ice ball formation achieved a mean maximum diameter of 2.5 cm (range, 1.6-2.6 cm) at 5 minutes, and a mean diameter of 2.7 cm (range, 2.4-3.2 cm) at 7 minutes. Cryoprobe temperatures were consistent throughout both studies. Conclusions: The Soprano Cryotherapy system produces rapid, reproducible ice ball formation of sufficient size and temperature to effectively result in endometrial ablation. A treatment time of 5 minutes decreases the potential for reaching dangerous serosal temperatures, resulting in potential complications. In vivo studies evaluating clinical outcome are ongoing.
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Monday Posters
ALIGNMENT OF THE UMBILICAL AXIS: AN EFFECTIVE MANEUVER FOR LAPAROSCOPIC ENTRY IN OBESE PATIENTS Marco A. Pelosi, 111,MD, and Marco A. Pelosi, MD Pelosi Women’sMedical Center, Bayonne,N] Background: In obese patients, a panniculus may cause a caudal deviation in the vertical axis of the umbilicus and make laparoscopic entry difficult. Technique: First, the presence or absence of caudal deviation of the umbilical axis is ascertained by measuring the distance between the external umbilical orifice and the anterior superior iliac spines along the length of the patient. Second, the caudally deviated umbilicus is displaced cranially by manual pressure on the panniculus so that the external umbilical orifice rests approximately 8 cm above the level of the anterior superior iliac spines. Third, open laparoscopy is performed through the base of the umbilicus by elevating it with clamps and incising skin, fascia, and peritoneum in a vertical axis. Experience: In an l&month period, 67 consecutive obese women (weight range, 99-213 kg) underwent surgery by the authors for gynecologic conditions requiring primary intraperitoneal evaluation or treatment. All of these patients were scheduled for laparoscopy and underwent the assessment, alignment, and entry technique described above to commence the operations. Laparoscopic entry by this technique was successful and rapid in all 67 cases and was not complicated by preperitoneal insufflation, subcutaneous emphysema, visceral injury, vascular injury, penetration of an underlying skin fold, or postoperative wound complications. ConcIusion: Umbilical axis assessment and alignment safely facilitate laparoscopy in obese patients.
EFFICACY AND SAFETY OF ORAL 17P-ESTRADIOL FOR THE TREATMENT OF VASOMOTOR SYMPTOMS IN POSTMENOPAUSAL WOMEN Frank A. van den Ouweland, MD, PhD, Pilar C. Lim, PhD, and Gary Shangold, MD R. W. JohnsonPharmaceuticalResearchInstitute, Basserdorf,Switzerland, and Raritan, NJ Objective: To evaluate the efficacy and safety of micronized 17/3-estradiol (E2) for the relief of moderate-to-severe vasomotor symptoms and impact on vaginal cytology.
Obstetrics b Gynecology
Methods: In this double-blind study, 145 postmenopausal women who experienced a minimum of eight moderate-tosevere hot flushes daily were randomly assigned to receive 0.5 or 1 mg E, or placebo once daily for 12 weeks. Efficacy end points included changes from baseline in frequency and severity of vasomotor symptoms and vaginal cytology (using the maturation index). Safety criteria included adverse events, bleeding or spotting, and endometrial biopsy. Results: Treatment with 1 or 0.5 mg E, resulted in fewer moderate-to-severe hot flushes versus placebo (mean change from baseline: -85.8%, -67.4% and 48.9%, respectively; P 7
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93, NO. 4 (SUPPLEMENT),
APRIL
1999
0.001 and P = 0.016). Both doses of E, significantly increased superficial and decreased parabasal vaginal cells versus placebo. Endometrial hyperplasia occurred in a dose-related manner among patients with an intact uterus: 0% in the placebo group, 6% in the 0.5 mg E, group, and 15% in the 1 mg E, group. Conclusion: The beneficial effects of E, on vasomotor symptom relief and vaginal cytology are significantly greater than those observed with placebo and appear to be dose-related.
Monday Posters 39s
38s
Monday Posters
ALIGNMENT OF THE UMBILICAL AXIS: AN EFFECTIVE MANEUVER FOR LAPAROSCOPIC ENTRY IN OBESE PATIENTS Marco A. Pelosi, 111,MD, and Marco A. Pelosi, MD Pelosi Women’sMedical Center, Bayonne,N] Background: In obese patients, a panniculus may cause a caudal deviation in the vertical axis of the umbilicus and make laparoscopic entry difficult. Technique: First, the presence or absence of caudal deviation of the umbilical axis is ascertained by measuring the distance between the external umbilical orifice and the anterior superior iliac spines along the length of the patient. Second, the caudally deviated umbilicus is displaced cranially by manual pressure on the panniculus so that the external umbilical orifice rests approximately 8 cm above the level of the anterior superior iliac spines. Third, open laparoscopy is performed through the base of the umbilicus by elevating it with clamps and incising skin, fascia, and peritoneum in a vertical axis. Experience: In an l&month period, 67 consecutive obese women (weight range, 99-213 kg) underwent surgery by the authors for gynecologic conditions requiring primary intraperitoneal evaluation or treatment. All of these patients were scheduled for laparoscopy and underwent the assessment, alignment, and entry technique described above to commence the operations. Laparoscopic entry by this technique was successful and rapid in all 67 cases and was not complicated by preperitoneal insufflation, subcutaneous emphysema, visceral injury, vascular injury, penetration of an underlying skin fold, or postoperative wound complications. ConcIusion: Umbilical axis assessment and alignment safely facilitate laparoscopy in obese patients.
EFFICACY AND SAFETY OF ORAL 17P-ESTRADIOL FOR THE TREATMENT OF VASOMOTOR SYMPTOMS IN POSTMENOPAUSAL WOMEN Frank A. van den Ouweland, MD, PhD, Pilar C. Lim, PhD, and Gary Shangold, MD R. W. JohnsonPharmaceuticalResearchInstitute, Basserdorf,Switzerland, and Raritan, NJ Objective: To evaluate the efficacy and safety of micronized 17/3-estradiol (E2) for the relief of moderate-to-severe vasomotor symptoms and impact on vaginal cytology.
Obstetrics b Gynecology
Methods: In this double-blind study, 145 postmenopausal women who experienced a minimum of eight moderate-tosevere hot flushes daily were randomly assigned to receive 0.5 or 1 mg E, or placebo once daily for 12 weeks. Efficacy end points included changes from baseline in frequency and severity of vasomotor symptoms and vaginal cytology (using the maturation index). Safety criteria included adverse events, bleeding or spotting, and endometrial biopsy. Results: Treatment with 1 or 0.5 mg E, resulted in fewer moderate-to-severe hot flushes versus placebo (mean change from baseline: -85.8%, -67.4% and 48.9%, respectively; P 7
VOL.
93, NO. 4 (SUPPLEMENT),
APRIL
1999
0.001 and P = 0.016). Both doses of E, significantly increased superficial and decreased parabasal vaginal cells versus placebo. Endometrial hyperplasia occurred in a dose-related manner among patients with an intact uterus: 0% in the placebo group, 6% in the 0.5 mg E, group, and 15% in the 1 mg E, group. Conclusion: The beneficial effects of E, on vasomotor symptom relief and vaginal cytology are significantly greater than those observed with placebo and appear to be dose-related.
Monday Posters 39s