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A Canadian multicenter evaluation of Cavaterm™ thermal balloon ablation
TUESDAY, SEPTEMBER 5
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Furthermore, the LNG IUS treatment is reversible and has no operative hazards or side effects.
FC2.23.04 A PROSPECTIVE OBSERVATIONAL STUDY OF MICROWAVE ENDOMETRIAL ABLATION (MEA) IN NEW ZEALAND WOMEN COMPLAINING OF MENSTRUAL DISTURBANCE D.T. McConnell, A. Dunn, Dept OB/GYN, Wellington School of Medicine, University of Otago, New Zealand. Objectives: Endometrial ablation as a surgical treatment for heavy menstrual loss has been validated for both patient safety and satisfaction. Our objective was to monitor the introduction and measure the menstrual function and quality of life in a cohort of women undergoing MEA. Study Methods: Design: prospective observational study. Population: 22 volunteers. Informed consent and ethical approval. Eligibility criteria: failed medical therapy (including progesterone laden IUCD), uterine size less than 12 weeks by clinical examination, normal endometrial histopathology, completed childbearing, lower uterine segment scar thickness greater than Emm if previous ceasarean section, five weeks Danazol endometrial preparation (2OGmg tds). Study variables: pre- and post-treatment menstrual scores and satisfaction levels, Short Form 36 general health questionnaire, perioperative complications. Technique: Microsulis PLC Microwave Endometrial Ablation equipment. The initial 30 treatments under general anesthesia and the subsequent cases under local anesthesia. Results: Recruitment: menstrual scoring identified a 60% incidence of dysmenorrhoea. Menstrual loss was described as heavy or very heavy in 100% of cases. Menstrual loss >7 days occurred in 60%. Baseline SF 36 data was collected in all women. Intraoperative: there were no complication of surgery. One woman required intraoperative conversion to Tram Cervical Endometrial resection because of equipment failure. Hysteroscopy identified multiple submucosal fibroids in one patient. The mean cavity length was 10.6 cm and the mean operative time was 5.5 minutes Conclusions: This study will recruit 50 women and aims to follow-up this cohort for 2 years. Initial results confirm the simplicity of MEA technique.
FC2.23.05 A CANADIAN MULTICENTER EVALUATION OF CAVATERM’” THERMAL BALLOON ABLATION R. Jackson (l), .I. Mayo (2), D. Small (3), R. Sabbah (4), H. Shenassa (5), .I. Y. Fontaine(6), (1) Dept. OB/GYN Peace Arch Hospital, White Rock, Canada (2) Royal Alexandra Hospital, Alberta, Canada (3) St. Joseph Hospital, Hamilton, Ontario (4) Hospital do Sacre-Coeur, Montreal, Canada (5) Ottawa Civic Hospital, Ottawa, Canada (6) Hospital Saint-Francois d’Assise, Quebec City, Canada Objectives: To report preliminary results of a Canadian evaluation of CavatermTH (Wallstem Medical, Switzerland). Study Methods: Participants were 100 women with menorrhagia and a normal uterine cavity determined by hysteroscopy, normal endometrial biopsy and cervical cytology. CavatermTH is an adjustable silicone balloon catheter with a vigorous fluid circulating system using “soft heat”. Mean operating pressure of 180 mm Hg and temperature of 75°C for 15 minutes. The treatment was done on a random cycle days and with no pre-treatment with GnRH analogs. The primary end point was a reduction in menstrual flow. Results: Patients satisfaction exceeded 90%. European data on CavatermTH with 6 years of follow-up report satisfaction rates of 91% and amenorrhoea-hypermenorrhoea combined rates of 64%. Conclusions: CavatermTH is a safe and effective treatment for menorrhagia.
FC2.23.06 MICROWAVE ENDOMETRIAL ABLATION: A RANDOMISED TRIAL OF ACCEPTABILITY OF LOCAL VERSUS GENERAL ANAESTHETIC TREATMENT Sarah Wallaee, Aberdeen Royal Infirmary, Scotland Background: M.E.A. has been compared with T.C.R.E. in a randomised trial and has similar levels of patient satisfaction at one year (80%). A pilot study has confirmed that treatment under local anaesthetic is feasible. Objective: To assess the acceptability of M.E.A. under local anaesthetic with a view to transferring treatments from theatre to a dedicated clinic setting. Methods: The trial is a partially randomised patient preference study with 180 randomised patients. Women are recruited and treated at Aberdeen Royal Infirmary, Scotland. Approximately two thirds of eligible patients agree to randomisation. The M.E.A. procedure involves cervical dilation to Hegar 9, hysteroscopy and then active microwave treatment which takes between 2 and 3 minutes depending on the size of the uterine cavity. The local anaesthetic consists of a four quadrant intracervical block using prilocaine 3% and felypressin (CitanestTH). Midazolam intravenous sedation is used if necessary. Preoperative NSAIDs are prescribed. Baseline patient characteristics including obstetric and gynaecological history, menstrual symptoms and anxiety & depression levels are recorded. Operative details including cavity length, treatment times and analgesic needs are noted. Acceptability is assessed by patient questionnaires postoperatively before discharge and at 2 weeks after surgery. Conclusions: Local anaesthetic is regarded as highly acceptable by patients. More than 80% of procedures can be completed under local anaesthetic and success does not seem affected by parity or previous cervical surgery. Only light sedation is needed if at all. M.E.A. is acceptable to patients under local anaesthesia and could be performed as an office procedure.
FC2.23.07 TWO YEAR FOLLOW-UP OF A RANDOMISED CONTROLLED TRIAL COMPARING TRANSCERVICAL RESECTION OF ENDOMETRIUM VS. MICROWAVE ENDOMETRIAL ABLATION C.Bain. K.G. Cooper, D.E. Parkin Obstetrics and Gynaecology Dept. Aberdeen Royal Infirmary, Aberdeen, Scotland Objectives: The aim of this study was to assess the continuing efficacy of a second generation endometrial ablative method with tramcervical resection of endometrium (TCRE), a well documented endometrial ablative technique. Study Methods: Two hundred and sixty three women were included in this study and were randomly allocated either TCRE or MEA( Microsulis plc). All women completed clinical and sf36 questionnaires at operation, 4months, 12months and 24 months. Results: At 24 months, both groups are continuing to show high success 53% amenorrhoea in and satisfaction rates, an interim analysis reveals the MEA group compared to 38% in TCRE group,39% vs.51% lighter periods respectively. Satisfaction was 77% in the MEA group and 67% in the TCRE group.The final results will be presented as the study concludes in March 2000. Conclusion: Microwave Endometrial Ablation is at least as effective as tramcervical endometrial resection at 24 months, if not greater. However, further studies and continual long-term follow-up are required to confirm these results.
FC2.24
IN VITRO
FERTILIZATION
FC2.24.01 THE “STEP DOWN PROTOCOL” FOR IVF TREATMENT B.A. Lieberman, S. Sinah, D. Falconer, D.R. Brison, Manchester Service, Manchester, England.
Fertility
Objectives: To assess prospectively the effectiveness and safety of ovarian stimulation using a step down protocol for IVF. The initial doses of gonadotrophin are used to maximize follicular recruitment. The dose is then decreased to reduce further recruitment and to minimize the risk of OHSS.
64
Furthermore, the LNG IUS treatment is reversible and has no operative hazards or side effects.
FC2.23.04 A PROSPECTIVE OBSERVATIONAL STUDY OF MICROWAVE ENDOMETRIAL ABLATION (MEA) IN NEW ZEALAND WOMEN COMPLAINING OF MENSTRUAL DISTURBANCE D.T. McConnell, A. Dunn, Dept OB/GYN, Wellington School of Medicine, University of Otago, New Zealand. Objectives: Endometrial ablation as a surgical treatment for heavy menstrual loss has been validated for both patient safety and satisfaction. Our objective was to monitor the introduction and measure the menstrual function and quality of life in a cohort of women undergoing MEA. Study Methods: Design: prospective observational study. Population: 22 volunteers. Informed consent and ethical approval. Eligibility criteria: failed medical therapy (including progesterone laden IUCD), uterine size less than 12 weeks by clinical examination, normal endometrial histopathology, completed childbearing, lower uterine segment scar thickness greater than Emm if previous ceasarean section, five weeks Danazol endometrial preparation (2OGmg tds). Study variables: pre- and post-treatment menstrual scores and satisfaction levels, Short Form 36 general health questionnaire, perioperative complications. Technique: Microsulis PLC Microwave Endometrial Ablation equipment. The initial 30 treatments under general anesthesia and the subsequent cases under local anesthesia. Results: Recruitment: menstrual scoring identified a 60% incidence of dysmenorrhoea. Menstrual loss was described as heavy or very heavy in 100% of cases. Menstrual loss >7 days occurred in 60%. Baseline SF 36 data was collected in all women. Intraoperative: there were no complication of surgery. One woman required intraoperative conversion to Tram Cervical Endometrial resection because of equipment failure. Hysteroscopy identified multiple submucosal fibroids in one patient. The mean cavity length was 10.6 cm and the mean operative time was 5.5 minutes Conclusions: This study will recruit 50 women and aims to follow-up this cohort for 2 years. Initial results confirm the simplicity of MEA technique.
FC2.23.05 A CANADIAN MULTICENTER EVALUATION OF CAVATERM’” THERMAL BALLOON ABLATION R. Jackson (l), .I. Mayo (2), D. Small (3), R. Sabbah (4), H. Shenassa (5), .I. Y. Fontaine(6), (1) Dept. OB/GYN Peace Arch Hospital, White Rock, Canada (2) Royal Alexandra Hospital, Alberta, Canada (3) St. Joseph Hospital, Hamilton, Ontario (4) Hospital do Sacre-Coeur, Montreal, Canada (5) Ottawa Civic Hospital, Ottawa, Canada (6) Hospital Saint-Francois d’Assise, Quebec City, Canada Objectives: To report preliminary results of a Canadian evaluation of CavatermTH (Wallstem Medical, Switzerland). Study Methods: Participants were 100 women with menorrhagia and a normal uterine cavity determined by hysteroscopy, normal endometrial biopsy and cervical cytology. CavatermTH is an adjustable silicone balloon catheter with a vigorous fluid circulating system using “soft heat”. Mean operating pressure of 180 mm Hg and temperature of 75°C for 15 minutes. The treatment was done on a random cycle days and with no pre-treatment with GnRH analogs. The primary end point was a reduction in menstrual flow. Results: Patients satisfaction exceeded 90%. European data on CavatermTH with 6 years of follow-up report satisfaction rates of 91% and amenorrhoea-hypermenorrhoea combined rates of 64%. Conclusions: CavatermTH is a safe and effective treatment for menorrhagia.
FC2.23.06 MICROWAVE ENDOMETRIAL ABLATION: A RANDOMISED TRIAL OF ACCEPTABILITY OF LOCAL VERSUS GENERAL ANAESTHETIC TREATMENT Sarah Wallaee, Aberdeen Royal Infirmary, Scotland Background: M.E.A. has been compared with T.C.R.E. in a randomised trial and has similar levels of patient satisfaction at one year (80%). A pilot study has confirmed that treatment under local anaesthetic is feasible. Objective: To assess the acceptability of M.E.A. under local anaesthetic with a view to transferring treatments from theatre to a dedicated clinic setting. Methods: The trial is a partially randomised patient preference study with 180 randomised patients. Women are recruited and treated at Aberdeen Royal Infirmary, Scotland. Approximately two thirds of eligible patients agree to randomisation. The M.E.A. procedure involves cervical dilation to Hegar 9, hysteroscopy and then active microwave treatment which takes between 2 and 3 minutes depending on the size of the uterine cavity. The local anaesthetic consists of a four quadrant intracervical block using prilocaine 3% and felypressin (CitanestTH). Midazolam intravenous sedation is used if necessary. Preoperative NSAIDs are prescribed. Baseline patient characteristics including obstetric and gynaecological history, menstrual symptoms and anxiety & depression levels are recorded. Operative details including cavity length, treatment times and analgesic needs are noted. Acceptability is assessed by patient questionnaires postoperatively before discharge and at 2 weeks after surgery. Conclusions: Local anaesthetic is regarded as highly acceptable by patients. More than 80% of procedures can be completed under local anaesthetic and success does not seem affected by parity or previous cervical surgery. Only light sedation is needed if at all. M.E.A. is acceptable to patients under local anaesthesia and could be performed as an office procedure.
FC2.23.07 TWO YEAR FOLLOW-UP OF A RANDOMISED CONTROLLED TRIAL COMPARING TRANSCERVICAL RESECTION OF ENDOMETRIUM VS. MICROWAVE ENDOMETRIAL ABLATION C.Bain. K.G. Cooper, D.E. Parkin Obstetrics and Gynaecology Dept. Aberdeen Royal Infirmary, Aberdeen, Scotland Objectives: The aim of this study was to assess the continuing efficacy of a second generation endometrial ablative method with tramcervical resection of endometrium (TCRE), a well documented endometrial ablative technique. Study Methods: Two hundred and sixty three women were included in this study and were randomly allocated either TCRE or MEA( Microsulis plc). All women completed clinical and sf36 questionnaires at operation, 4months, 12months and 24 months. Results: At 24 months, both groups are continuing to show high success 53% amenorrhoea in and satisfaction rates, an interim analysis reveals the MEA group compared to 38% in TCRE group,39% vs.51% lighter periods respectively. Satisfaction was 77% in the MEA group and 67% in the TCRE group.The final results will be presented as the study concludes in March 2000. Conclusion: Microwave Endometrial Ablation is at least as effective as tramcervical endometrial resection at 24 months, if not greater. However, further studies and continual long-term follow-up are required to confirm these results.
FC2.24
IN VITRO
FERTILIZATION
FC2.24.01 THE “STEP DOWN PROTOCOL” FOR IVF TREATMENT B.A. Lieberman, S. Sinah, D. Falconer, D.R. Brison, Manchester Service, Manchester, England.
Fertility
Objectives: To assess prospectively the effectiveness and safety of ovarian stimulation using a step down protocol for IVF. The initial doses of gonadotrophin are used to maximize follicular recruitment. The dose is then decreased to reduce further recruitment and to minimize the risk of OHSS.