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Goserelin acetate as adjunctive therapy for endometrial ablation in women with dysfunctional uterine bleeding
SeJected Scientific Abstracts
change in menstrual bleeding (3, 4.8%). Two women had a repeat endometrial ablation and one had hysterectomy for menorrhagia and CPR Concomitant laparoscopic surgery and endometrial ablation is an effective alternative to hysterectomy for women with CPP and menorrhagia.
and exclusion criteria underwent endometrial ablation with a thermal balloon system. Forty-one (35 %) were treated under general and 71 (61%) under neuroleptic anesthesia. Four (3%) treatments were performed under paracervical block only. A 16-cm long, 3-mm diameter catheter with a latex balloon at its tip housing a heating element was inserted into the uterus and filled with sterile 5% dextrose in water solution (mean 10.4 ml, range 2-55 ml). The catheter was connected to a control unit that maintained the temperature at 87 _+5 ~ C, monitored the pressure, and terminated the treatment after 8 minutes. The starting uterine pressure was 80 to 140 mm Hg in the first 13 women and greater than 140 mm Hg in the rest. Nineteen women were treated for 12 minutes and all others for 8 minutes. Complications were endometritis (3), hematometra (2), and cystitis (1). At 6-month follow-up, after 8 minutes of treatment, persistent menorrhagia was reported by 38% and 12% of patients at less than and greater than 140 mm Hg pressure, respectively. At greater than 140 mm Hg pressure, menorrhagia was reported by 13% of women after 8 and 12 minutes of treatment. In 38 women, amenorrhea or spotting occurred in 29%, hypomenorrhea in 45%, eumenorrhea in 21%, and menorrhagia in 5 %. Uterine balloon therapy is a safe and effective treatment for menorrhagia at uterine pressures of 150 to 180 mm Hg and of 8 minutes' duration.
Economic Evaluation of Hysteroscopic Endometrial Ablation versus Vaginal Hysterectomy for Menorrhagia GA Vilos, JT Pispidikis, CK Botz. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Center, London, Ontario, Canada.
Between June 1992 and July 1993, 40 women with menorrhagia underwent vaginal hysterectomy, performed by 5 surgeons in one hospital. The patients were retrospectively compared with the first 40 women having endometrial ablation for menorrhagia performed during the same period by senior author. The age, parity, weight, and uterine size were similar in both groups. Measurable costs were surgical time, procedure time (anesthetist and resource use in operating room), length of hospital stay, convalescence (value of patient time), and indirect costs associated with subsequent surgical procedures. Measurable benefits were estimated blood loss, complications, and effectiveness of the procedure. The total cost per episode of care was estimated to be $5373 and $2279 (1995 $ Canadian) for vaginal hysterectomy and hysteroscopic endometrial ablation, respectively, for a mean saving of $3094. The benefits derived from both procedures were comparable. Vaginal hysterectomy eliminated bleeding in 100% of women and was associated with a complication rate of 41%. Endometrial ablation eliminated or improved bleeding in 90% of women (amenorrhea 46%, hypomenorrhea 35%, eumenorrhea 9%, no significant change 10%), was associated with no complications, and resulted in 82% satisfaction. Endometrial ablation is 82% effective and 58% less expensive than vaginal hysterectomy for the treatment of women with menorrhagia.
Goserelin Acetate as Adjunctive Therapy for Endometrial Ablation in Women with Dysfunctional Uterine Bleeding GA Vilos, J Donnez, M Gannon, S Stampe-Sorensen, J Klinte, RM Miller. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
The multinational, multicenter, prospective, double-blind study compared randomized 358 premenopausal women with regular cycles to receive two injections 1 month apart of goserelin acetate depot or sham depot before endometrial ablation. Injections were started to permit surgery (resection + rollerball) 6 weeks later on day 7 of the cycle when the endometrium would be at its thinnest for the sham group, and allowing down-regulation to continue after surgery. End points were endometrial thickness at surgery, change in blood loss score, amenorrhea, severe hypomenorrhea (score <10), ease and duration of surgery, fluid absorption, change in pain score and endometrial histology. Intent-to-treat analysis was
Uterine Balloon Therapy for the Treatment of Menorrhagia GA Vilos, C Fortin, B Sanders, L Pendley, M McColl. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
From June 1994 to December 1995, 116 women (mean age 39 yrs, range 27-50 yrs) who met inclusion $54
August 1996, Vd. 3, No. 4 Supplement TheJournal of the American Association of Gynecologic Laparoscopists
performed. Significantly more women receiving goserelin experienced amenorrhea (40%) than those receiving sham (26%, p = 0.004). The change in blood loss score was significantly reduced from baseline but not different between the groups. The combination of amenorrhea and severe hypomenorrhea favored the goserelin group (p = 0.059). Mean endometrial thickness for goserelin was 1.6 mm and for sham 3.4 mm (p = 0.0001). The majority of women given goserelin had atrophic glands and stroma. Surgery in these patients was significantly shorter (22%, p = 0.0001) and easier than for those treated with sham (p = 0.0001). Operative complications were similar between the groups, with a small but significant difference in favor of goserelin for less fluid absorption (p = 0.04). Pain scores were reduced in both groups. Patient satisfaction was very high in both groups (>92%) with a very low reintervention rate (2.8% for both groups). Overall menstrual loss was reduced. Despite timing the surgery to favor the sham group, the goserelin-treated women had significantly more amenorrhea and significant thinner endometria than seen in the immediate postmenstrual phase, and this resulted in significantly shorter and easier surgery.
Economic Evaluation of In Vitro Fertilization with Embryo Transfer and Neosalpingostomy by Laparotomy or Laparoscopy
$28,100 after laparotomy and IVF-ET, respectively. The reproductive performance after bilateral laparoscopic neosalpingostomy in selected patients is at least equal to that after neosalpingostomy by laparotomy and a single IVF-ET cycle. The least expensive live birth is associated with laparoscopic neosalpingostomy.
The Frequency of Endometriosis in Women with Pelvic Pain and Large Leiomyomata Uteri L Weather Jr. Omni Fertility and Laser Institute, New Orleans, LA.
Between April 1989 and February 1996 pelviscopy was performed to evaluate 65 patients with pelvic pain and findings consistent with large leiomyomata uteri. The principal findings in 55 women (84.60%) were a mass of 19 weeks' size and endometriosis. Endometriosis should be considered in women with large leiomyomata uteri who complain of pelvic pain.
Patient Satisfaction with Laparoscopic-Assisted Removal of Large Myomas 1MD Whittaker, 2R Garry. Whe WEL Foundation, St. James's University Hospital, Leeds, UK; 2The WEL Foundation, South Cleveland Hospital, Middlesbrough, UK.
The main indications for laparoscopic myomectomy in 10 women (mean age 39.8 yrs) were symptomatic pelvic mass (9), menorrhagia (6), dyspareunia (5), dysmenorrhea (2), and infertility (2). All patients had one or more fibroids larger than 5 cm removed, and in seven the myomata were larger than 10 cm. The mean fibroid mass was 394.7 g (range 130-675 g), and extensive morcellation was required in all women. The mean length of surgery was 153 minutes and hospital stay 3 to 4 days. Overall recovery was excellent in seven and good in three patients. The mean return to normal activity and work was 5.3 weeks (mode 3.0 wks, median 4.5 wks). All women reported improvement in their symptoms as follows: symptomatic mass (9), gone in six and smaller in three; menorrhagia (6), lighter in five and unchanged in one; dyspareunia (5), gone in four and less in 1; dysmenorrhea (2) gone and less in one each. Of the three women trying to conceive since the procedure, two were successful. The mean scar length was 4.9 cm (range 1~5 cm), reported by five women as expected, by four as shorter, and one as longer than expected, but all the patients were satisfied with the scars.
GA Vilos, CR Verhoest, JS Martin, C 13otz. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
Three cohorts of infertile women were treated for bilateral tubal obstruction. From July 1990 to July 1994, 37 distal tubal obstruction were treated with laparoscopic bilateral neosalpingostomy using a Coherent ultrapulse carbon dioxide (CO2) laser. Before July 1990, 72 with distal obstruction had neosalpingostomy by laparotomy using the CO2 laser and microsurgical techniques. From July 1990 to December 1994, 127 women with all forms of bilateral tubal obstruction were treated with a first cycle of in vitro fertilization-embryo transfer (IVF-ET). The groups were comparable for age and length of infertility. The live birth rates were 19% (14/72) and 22% (8/37), and the ectopic pregnancy rates 7% (5) and 8% (3) in the laparotomy and laparoscopy groups, respectively. The corresponding rates for the IVF-ET group were 19% (24) and 3% (4). The estimated costs for a live birth were $8573 after laparoscopy and $27,773 and
$55
change in menstrual bleeding (3, 4.8%). Two women had a repeat endometrial ablation and one had hysterectomy for menorrhagia and CPR Concomitant laparoscopic surgery and endometrial ablation is an effective alternative to hysterectomy for women with CPP and menorrhagia.
and exclusion criteria underwent endometrial ablation with a thermal balloon system. Forty-one (35 %) were treated under general and 71 (61%) under neuroleptic anesthesia. Four (3%) treatments were performed under paracervical block only. A 16-cm long, 3-mm diameter catheter with a latex balloon at its tip housing a heating element was inserted into the uterus and filled with sterile 5% dextrose in water solution (mean 10.4 ml, range 2-55 ml). The catheter was connected to a control unit that maintained the temperature at 87 _+5 ~ C, monitored the pressure, and terminated the treatment after 8 minutes. The starting uterine pressure was 80 to 140 mm Hg in the first 13 women and greater than 140 mm Hg in the rest. Nineteen women were treated for 12 minutes and all others for 8 minutes. Complications were endometritis (3), hematometra (2), and cystitis (1). At 6-month follow-up, after 8 minutes of treatment, persistent menorrhagia was reported by 38% and 12% of patients at less than and greater than 140 mm Hg pressure, respectively. At greater than 140 mm Hg pressure, menorrhagia was reported by 13% of women after 8 and 12 minutes of treatment. In 38 women, amenorrhea or spotting occurred in 29%, hypomenorrhea in 45%, eumenorrhea in 21%, and menorrhagia in 5 %. Uterine balloon therapy is a safe and effective treatment for menorrhagia at uterine pressures of 150 to 180 mm Hg and of 8 minutes' duration.
Economic Evaluation of Hysteroscopic Endometrial Ablation versus Vaginal Hysterectomy for Menorrhagia GA Vilos, JT Pispidikis, CK Botz. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Center, London, Ontario, Canada.
Between June 1992 and July 1993, 40 women with menorrhagia underwent vaginal hysterectomy, performed by 5 surgeons in one hospital. The patients were retrospectively compared with the first 40 women having endometrial ablation for menorrhagia performed during the same period by senior author. The age, parity, weight, and uterine size were similar in both groups. Measurable costs were surgical time, procedure time (anesthetist and resource use in operating room), length of hospital stay, convalescence (value of patient time), and indirect costs associated with subsequent surgical procedures. Measurable benefits were estimated blood loss, complications, and effectiveness of the procedure. The total cost per episode of care was estimated to be $5373 and $2279 (1995 $ Canadian) for vaginal hysterectomy and hysteroscopic endometrial ablation, respectively, for a mean saving of $3094. The benefits derived from both procedures were comparable. Vaginal hysterectomy eliminated bleeding in 100% of women and was associated with a complication rate of 41%. Endometrial ablation eliminated or improved bleeding in 90% of women (amenorrhea 46%, hypomenorrhea 35%, eumenorrhea 9%, no significant change 10%), was associated with no complications, and resulted in 82% satisfaction. Endometrial ablation is 82% effective and 58% less expensive than vaginal hysterectomy for the treatment of women with menorrhagia.
Goserelin Acetate as Adjunctive Therapy for Endometrial Ablation in Women with Dysfunctional Uterine Bleeding GA Vilos, J Donnez, M Gannon, S Stampe-Sorensen, J Klinte, RM Miller. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
The multinational, multicenter, prospective, double-blind study compared randomized 358 premenopausal women with regular cycles to receive two injections 1 month apart of goserelin acetate depot or sham depot before endometrial ablation. Injections were started to permit surgery (resection + rollerball) 6 weeks later on day 7 of the cycle when the endometrium would be at its thinnest for the sham group, and allowing down-regulation to continue after surgery. End points were endometrial thickness at surgery, change in blood loss score, amenorrhea, severe hypomenorrhea (score <10), ease and duration of surgery, fluid absorption, change in pain score and endometrial histology. Intent-to-treat analysis was
Uterine Balloon Therapy for the Treatment of Menorrhagia GA Vilos, C Fortin, B Sanders, L Pendley, M McColl. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
From June 1994 to December 1995, 116 women (mean age 39 yrs, range 27-50 yrs) who met inclusion $54
August 1996, Vd. 3, No. 4 Supplement TheJournal of the American Association of Gynecologic Laparoscopists
performed. Significantly more women receiving goserelin experienced amenorrhea (40%) than those receiving sham (26%, p = 0.004). The change in blood loss score was significantly reduced from baseline but not different between the groups. The combination of amenorrhea and severe hypomenorrhea favored the goserelin group (p = 0.059). Mean endometrial thickness for goserelin was 1.6 mm and for sham 3.4 mm (p = 0.0001). The majority of women given goserelin had atrophic glands and stroma. Surgery in these patients was significantly shorter (22%, p = 0.0001) and easier than for those treated with sham (p = 0.0001). Operative complications were similar between the groups, with a small but significant difference in favor of goserelin for less fluid absorption (p = 0.04). Pain scores were reduced in both groups. Patient satisfaction was very high in both groups (>92%) with a very low reintervention rate (2.8% for both groups). Overall menstrual loss was reduced. Despite timing the surgery to favor the sham group, the goserelin-treated women had significantly more amenorrhea and significant thinner endometria than seen in the immediate postmenstrual phase, and this resulted in significantly shorter and easier surgery.
Economic Evaluation of In Vitro Fertilization with Embryo Transfer and Neosalpingostomy by Laparotomy or Laparoscopy
$28,100 after laparotomy and IVF-ET, respectively. The reproductive performance after bilateral laparoscopic neosalpingostomy in selected patients is at least equal to that after neosalpingostomy by laparotomy and a single IVF-ET cycle. The least expensive live birth is associated with laparoscopic neosalpingostomy.
The Frequency of Endometriosis in Women with Pelvic Pain and Large Leiomyomata Uteri L Weather Jr. Omni Fertility and Laser Institute, New Orleans, LA.
Between April 1989 and February 1996 pelviscopy was performed to evaluate 65 patients with pelvic pain and findings consistent with large leiomyomata uteri. The principal findings in 55 women (84.60%) were a mass of 19 weeks' size and endometriosis. Endometriosis should be considered in women with large leiomyomata uteri who complain of pelvic pain.
Patient Satisfaction with Laparoscopic-Assisted Removal of Large Myomas 1MD Whittaker, 2R Garry. Whe WEL Foundation, St. James's University Hospital, Leeds, UK; 2The WEL Foundation, South Cleveland Hospital, Middlesbrough, UK.
The main indications for laparoscopic myomectomy in 10 women (mean age 39.8 yrs) were symptomatic pelvic mass (9), menorrhagia (6), dyspareunia (5), dysmenorrhea (2), and infertility (2). All patients had one or more fibroids larger than 5 cm removed, and in seven the myomata were larger than 10 cm. The mean fibroid mass was 394.7 g (range 130-675 g), and extensive morcellation was required in all women. The mean length of surgery was 153 minutes and hospital stay 3 to 4 days. Overall recovery was excellent in seven and good in three patients. The mean return to normal activity and work was 5.3 weeks (mode 3.0 wks, median 4.5 wks). All women reported improvement in their symptoms as follows: symptomatic mass (9), gone in six and smaller in three; menorrhagia (6), lighter in five and unchanged in one; dyspareunia (5), gone in four and less in 1; dysmenorrhea (2) gone and less in one each. Of the three women trying to conceive since the procedure, two were successful. The mean scar length was 4.9 cm (range 1~5 cm), reported by five women as expected, by four as shorter, and one as longer than expected, but all the patients were satisfied with the scars.
GA Vilos, CR Verhoest, JS Martin, C 13otz. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
Three cohorts of infertile women were treated for bilateral tubal obstruction. From July 1990 to July 1994, 37 distal tubal obstruction were treated with laparoscopic bilateral neosalpingostomy using a Coherent ultrapulse carbon dioxide (CO2) laser. Before July 1990, 72 with distal obstruction had neosalpingostomy by laparotomy using the CO2 laser and microsurgical techniques. From July 1990 to December 1994, 127 women with all forms of bilateral tubal obstruction were treated with a first cycle of in vitro fertilization-embryo transfer (IVF-ET). The groups were comparable for age and length of infertility. The live birth rates were 19% (14/72) and 22% (8/37), and the ectopic pregnancy rates 7% (5) and 8% (3) in the laparotomy and laparoscopy groups, respectively. The corresponding rates for the IVF-ET group were 19% (24) and 3% (4). The estimated costs for a live birth were $8573 after laparoscopy and $27,773 and
$55