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Concomitant laparoscopic surgery and hysteroscopic endometrial ablation for women with chronic pelvic pain and menorrhagia
August 1996, Vol. 3, No. 4 Supplement
The Journal of the American Association of Gynecologic Laparoscopists
Goserelin Depot Treatment Before Endometriai Resection
Laparoscopy versus Laparotomy for Radical Hysterectomy
1p Vercellini, 2p Perino, 3R Consonni, 1S Oldani, 4F Parazzini, ~PG Crosignani. ~Clinica Ostetrica e Ginecologica, University of Milan, Milan, Italy; 2Clinica Ostetrica e Ginecologica, University of Palermo, Palmero, Italy; 3Divisione di Ostetricia e Ginecologia, Ospedale Valduce, Como, Italy; 41nstituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
O Vidal, JG Garza-Leal. University Hospital, Monterrey, Nuevo Leon, Mexico.
To ascertain whether treatment with a gonadotropin-releasing hormone agonist before endometrial resection reduces absorption of distention fluid and operating time, facilitates the procedure, and improves long-term bleeding pattern, 71 menorrhagic women were allocated to 8 weeks of goserelin depot treatment before operative hysteroscopy or immediate surgery in the early proliferative phase of the cycle. Eight patients withdrew from the study after randomization, leaving 33 in the goserelin ann and 30 in the immediate surgery arm. Mean (SD) operating time was 15.1 (9.0) minutes in the goserelin group versus 16.9 (9.5) minutes in the controls (mean difference 1.8 min, 95% C1-2.9-6.4). Mean (SD) distention medium deficit was, respectively, 422 (287 ml) and 564 ml (291 ml; mean difference 142 ml, 95% C1-4-288). Considering only the 29 women with adenomyosis, the mean (SD) fluid deficit was considerably less in the 19 goserelin-treated group than in the 10 controls, 299 (206) versus 597 (135) ml (mean difference 298 ml, 95% CI 149447). The surgeons classified intraoperative difficulties as none in 6, minimal in 20, moderate in 7, and severe in no cases in the goserelin group; corresponding figures in the group without pretreatment were 2, 14, 13, and 1 (p = 0.02). At 12-month follow-up 35% of women in the goserelin group were amenorrheic, 23% hypomenorrheic, 42% eumenorrheic, and none hypermenorrheic. Corresponding figures in the immediate surgery group were, respectively, 20%, 30%, 37%, and 13%. Goserelin administration before endometrial resection may reduce absorption of fluid at surgery in some patients and may facilitate intrauterine operating conditions. Effects on long-term bleeding patterns were limited.
From July 1993 to March 1996 we performed 62 radical hysterectomies, 15 (24.2%) by laparoscopy and 47 (75.8%) by laparotomy. All patients had cervical carcinoma FIGO stages Ia2 and lbl. We compared the duration of surgery, blood loss, number of pelvic nodes obtained, surgical margins, and complications. The average duration of laparoscopic surgery was 4.5 hours versus 3 hours for laparotomy. Blood loss at laparoscopy was 250 ml, and 600 ml at laparotomy. The number of pelvic nodes obtained by laparotomy was 24.74 and by laparoscopy an average of 25. In all cases the surgical margins were free of tumors. Two complications in the laparoscopy group were a vaginal hematoma and a ureteral injury. At laparotomy one ureteral fistula occurred. No difference between approaches in pathology specimens were seen. Blood loss was lower at laparoscopy but the duration of surgery was longer. Radical hysterectomy by laparoscopy seems safe and effective. Concomitant taparoscopic Surgery and Hysteroscopic Endometrial Ablation for Women with Chronic Pelvic Pain and Menorrhagia GA Vilos, AD Drossos, EC Vilos. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
From September 1993 to July 1995, 63 women (mean age 38 yrs, range 26-53 yrs, parity 0-7) with chronic pelvic pain (CPP) and menorrhagia underwent outpatient laparoscopic surgery and endometrial ablation. Operating time ranged from 9 to 110 minutes (mean 52 min). Laparoscopic procedures included excision of endometriosis (26), adhesiolysis (17), electromyolysis (4), uterine suspension (6), and appendectomy (4). At 6 to 20 months' follow-up 63 women reported no pain (24, 38.1%), significant improvement of pain (25, 39.7%), no change in amount of pain (9, 14.3%), and an increase of pain (5, 7.9%). Six patients had repeat laparoscopy. After hysteroscopic endometrial rollerball ablation and resection, the same women reported amenorrhea (31, 49.2%), hypomenorrhea (26, 41.3%), eumenorrhea (3, 4.8%), and no
$53
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
The Journal of the American Association of Gynecologic Laparoscopists
Goserelin Depot Treatment Before Endometriai Resection
Laparoscopy versus Laparotomy for Radical Hysterectomy
1p Vercellini, 2p Perino, 3R Consonni, 1S Oldani, 4F Parazzini, ~PG Crosignani. ~Clinica Ostetrica e Ginecologica, University of Milan, Milan, Italy; 2Clinica Ostetrica e Ginecologica, University of Palermo, Palmero, Italy; 3Divisione di Ostetricia e Ginecologia, Ospedale Valduce, Como, Italy; 41nstituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
O Vidal, JG Garza-Leal. University Hospital, Monterrey, Nuevo Leon, Mexico.
To ascertain whether treatment with a gonadotropin-releasing hormone agonist before endometrial resection reduces absorption of distention fluid and operating time, facilitates the procedure, and improves long-term bleeding pattern, 71 menorrhagic women were allocated to 8 weeks of goserelin depot treatment before operative hysteroscopy or immediate surgery in the early proliferative phase of the cycle. Eight patients withdrew from the study after randomization, leaving 33 in the goserelin ann and 30 in the immediate surgery arm. Mean (SD) operating time was 15.1 (9.0) minutes in the goserelin group versus 16.9 (9.5) minutes in the controls (mean difference 1.8 min, 95% C1-2.9-6.4). Mean (SD) distention medium deficit was, respectively, 422 (287 ml) and 564 ml (291 ml; mean difference 142 ml, 95% C1-4-288). Considering only the 29 women with adenomyosis, the mean (SD) fluid deficit was considerably less in the 19 goserelin-treated group than in the 10 controls, 299 (206) versus 597 (135) ml (mean difference 298 ml, 95% CI 149447). The surgeons classified intraoperative difficulties as none in 6, minimal in 20, moderate in 7, and severe in no cases in the goserelin group; corresponding figures in the group without pretreatment were 2, 14, 13, and 1 (p = 0.02). At 12-month follow-up 35% of women in the goserelin group were amenorrheic, 23% hypomenorrheic, 42% eumenorrheic, and none hypermenorrheic. Corresponding figures in the immediate surgery group were, respectively, 20%, 30%, 37%, and 13%. Goserelin administration before endometrial resection may reduce absorption of fluid at surgery in some patients and may facilitate intrauterine operating conditions. Effects on long-term bleeding patterns were limited.
From July 1993 to March 1996 we performed 62 radical hysterectomies, 15 (24.2%) by laparoscopy and 47 (75.8%) by laparotomy. All patients had cervical carcinoma FIGO stages Ia2 and lbl. We compared the duration of surgery, blood loss, number of pelvic nodes obtained, surgical margins, and complications. The average duration of laparoscopic surgery was 4.5 hours versus 3 hours for laparotomy. Blood loss at laparoscopy was 250 ml, and 600 ml at laparotomy. The number of pelvic nodes obtained by laparotomy was 24.74 and by laparoscopy an average of 25. In all cases the surgical margins were free of tumors. Two complications in the laparoscopy group were a vaginal hematoma and a ureteral injury. At laparotomy one ureteral fistula occurred. No difference between approaches in pathology specimens were seen. Blood loss was lower at laparoscopy but the duration of surgery was longer. Radical hysterectomy by laparoscopy seems safe and effective. Concomitant taparoscopic Surgery and Hysteroscopic Endometrial Ablation for Women with Chronic Pelvic Pain and Menorrhagia GA Vilos, AD Drossos, EC Vilos. Department of Obstetrics and Gynecology, University of Western Ontario, St. Joseph's Health Care Centre, London, Ontario, Canada.
From September 1993 to July 1995, 63 women (mean age 38 yrs, range 26-53 yrs, parity 0-7) with chronic pelvic pain (CPP) and menorrhagia underwent outpatient laparoscopic surgery and endometrial ablation. Operating time ranged from 9 to 110 minutes (mean 52 min). Laparoscopic procedures included excision of endometriosis (26), adhesiolysis (17), electromyolysis (4), uterine suspension (6), and appendectomy (4). At 6 to 20 months' follow-up 63 women reported no pain (24, 38.1%), significant improvement of pain (25, 39.7%), no change in amount of pain (9, 14.3%), and an increase of pain (5, 7.9%). Six patients had repeat laparoscopy. After hysteroscopic endometrial rollerball ablation and resection, the same women reported amenorrhea (31, 49.2%), hypomenorrhea (26, 41.3%), eumenorrhea (3, 4.8%), and no
$53
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