- Email: [email protected]
Laparoscopic Tubal Anastomosis With and Without Robotic Assistance
of embryos transferred based on the woman’s age, embryo quality and cleavage rates. Design: Retrospective review of first and second cycles from fresh embryo transfers between 04/1997 and 12/1999. Materials and Methods: After April 1, 1997, the number of embryos transferred was limited to two in women ,35 years (n5226) and three in women 35–39 years (n5393). Embryo cleavage and morphology were assessed immediately prior to transfer on day 3. A good quality embryo was defined as $6 cells with #10% fragmentation. Results:
No. good quality embryos
,35 years; 2 embryos transferred 0
1
2
table analysis. Eight retrospective studies were identified that compared treatment to no treatment and suggested that outcomes without intervention were comparable to those after resection. Conclusion: Recommendations (class C recommendations) for resection of a uterine septum are based on relatively weak data. No randomized, controlled trials were identified. Most studies showing efficacy were observational, of low power and with poor follow-up. No standard definition of a septate uterus could be identified. These results suggest the need for explicit, reliable evidence through randomized trials to identify patient profiles most likely to benefit from this surgery, appropriate risks and a standard definition for inclusion in such trials.
35–39 years; 3 embryos transferred 0
1
2
3
Cycles 11 35 180 21 55 87 230 Clinical preg2 (18.2) 11 (31.4) 68 (37.8) 4 (19) 14 (25.5) 35 (40.2) 78 (33.9) nancy (%) 1 sac (%) 2 8 (72.7) 50 (73.5) 4 (100) 9 (64.3) 19 (54.3) 51 (65.4) 2 sacs (%) – 3 (27.3) 18 (26.5) 0 (0) 5 (35.7) 13 (37.1) 21 (26.9) 3 sacs (%) – – – – – 3 (8.6) 6 (7.7) a 11.5 20.7b 16.1b Implantation (%) 9.1 20 23.8 6.3
P,0.05 a versus ba.
Implantation rates approached 20% following the transfer of one good quality embryo in women ,35 years & two good quality embryos in women between 35 and 39 years. Neither implantation nor pregnancy rates improved substantially beyond this threshold, despite the addition of one or two other embryos of variable quality. Small, but finite implantation rates of lesser quality embryos presumably accounted for the variability in implantation between groups. Conclusions: With implantation rates that approach or exceed 20%, these data support our decision to limit the number of embryos transferred. Furthermore, the data suggest that an additional reduction in the number of embryos transferred can be implemented without compromising pregnancy rates. We have eliminated trizygotic triplet gestations in women under 35 years in our program, and are encouraged by recent ASRM guidelines supporting limitation of embryo number.
REPRODUCTIVE SURGERY Monday, October 23, 2000
P-166 Reduction of Adhesion Reformation After Adhesiolysis in Pelvic Laparoscopy Using 4% Icodextrin Solution as an Intra-Operative Lavage and a Post-Operative Instillate. 1S. J. Verco, 2G. S. diZerega, 1E. M. Peers, the CLASSIC Study Group. 1ML Laboratories PLC, Blaby, Leicester, and 2University of Southern California, School of Medicine, Los Angeles, CA. Objective: Adhesion formation and reformation after abdominal surgery is a common occurrence with 34% of patients twice readmitted to hospital owing to adhesion-related problems during a ten year post-surgical period (Lancet, 1999; 353: 1476 – 80). Our aim was to assess the effect of a glucose polymer solution (4% icodextrin) on the reduction of adhesion formation and reformation in the abdominal surgery situation. Design: Sixty obstetric/gynecology patients requiring surgery (including adhesiolysis) for pelvic pain/fertility problems were recruited to an open, parallel group, five centre, randomized study. Materials and Methods: 4% icodextrin solution (Adept™) or Ringer lactate solution (RLS) were administered $100 ml per 30 minutes intraoperatively followed by 1L post-procedure via intraperitoneal laparoscope. A second-look procedure was undertaken 6 –12 weeks later. The interim data from 30 completed patient procedures have been analyzed for efficacy (n525) using the mAFS (modified American Fertility Society) score for incidence, extent and severity of post-operative adhesions, and for tolerability (n530). Results are presented from 17 adhesiolysis procedures (4% icodextrin, n59; RLS, n58). Results: There were no adverse events related to study treatments. Mean % reduction (SD) in adhesion number per patient was 60.5% (38.9) for icodextrin and 22.7% (164.3) for RLS treated patients. The tabulated data represent adhesion extent and reformation:
P-165 Assessing the Quality of Evidence in Support of Resection of a Uterine Septum. G. S. Letterie. Center for Fertility and Reproductive Endocrinology, Virginia Mason Medical Center, Seattle, WA. Objectives: Though well entrenched as a recommended therapy in select circumstances, the rationale and strength for resection of a uterine septum remains unclear. The purpose of the present study was to evaluate the quality of evidence in support of resection of a uterine septum using an evidence based approach. Design: Survey of published trials describing outcomes after treatment of septate uterus. Data Sources: A search of MEDLINE database of English-language journals was performed to locate relevant articles published between 1985 and 1999. Original research and review articles were included. Abstracts at scientific conferences were not. Additional studies were located by handsearching bibliographies of articles retrieved in the search. Main Outcomes Measures: Publications were reviewed for study design, inclusion of any definition of septate uterus and postoperative evaluation of the endometrial cavity. The data describing study design were classified using the rating system of the U.S. Preventive Services Task Force. Results: One hundred and ten articles were reviewed. No standard, quantitative definition of a septate uterus was identified. Twenty-five articles included both septate and arcuate uterus in the study groups. There were no randomized, prospective studies evaluating the efficacy of this surgery. Most studies were observational using treated patients as their own controls and limited case series (class II-3 and III evidence). Thirty-five percent of the articles included evaluation of the uterine cavity after resection either with hysterosalpingography or hysteroscopy. Three percent included a life
FERTILITY & STERILITYt
4% icodextrin RLS
No. adhesions at 1st surgery (SD)
No. adhesions at 2nd surgery (SD)
Extent % reduction (SD) [mean per patient]
% Reformation (SD) [mean per patient]
5.4 (3.8) 3.8 (3.2)
1.7 (2.9) 1.3 (1.5)
65.8 (33.3) 22.5 (165.5)
17.7 (26.6) 39.6 (43.0)
Conclusion: The results of the interim analysis of this pilot study indicate that 4% icodextrin is well tolerated by patients, and reduces adhesion formation and reformation after abdominal surgery when used as a wash during the surgical procedure and as a post-operative instillate. This research was supported by ML Laboratories PLC, UK.
P-167 Laparoscopic Tubal Anastomosis With and Without Robotic Assistance. J. M. Goldberg, T. Falcone. Department of Gynecology and Obstetrics, The Cleveland Clinic Foundation, Cleveland, OH. Objective: The objective was to compare procedure duration, length of hospitalization and estimated blood loss for laparoscopic tubal anastomosis performed with and without laparoscopic assistance. Design: A retrospective chart review of all laparoscopic tubal anastomoses excluding 2 cornual repairs was performed. Materials and Methods: Outpatient laparoscopic tubal anastomosis was performed on 24 patients with the same technique used at laparotomy. After opening the occluded segments, the mesosalpinx was reapproximated with an interrupted 6-0 delayed absorbable suture. The anastomosis was per-
S147
formed by placing 4 interrupted 8-0 delayed absorbable sutures incorporating the muscularis and mucosal layers. The serosa was also closed with interrupted 8-0 delayed absorbable sutures. No stents were used. Tubal patency was demonstrated intraoperatively. The first 10 procedures were performed with robotic assistance using the Zeus system (Computer Motion, Santa Barbara, CA) for the laparoscopic suturing. The surgeon was seated at a console with a video monitor and manipulated the handles which translated the movements to the instruments. The subsequent 14 cases were performed without the robot with each surgeon serving as 1 “hand” for laparoscopic knot tying. The total operating room (OR), anesthesia and actual procedure times were recorded as well as the estimated blood loss (EBL), time in the recovery room (RR) and total length of stay (LOS). All times are in minutes and the results are reported as the median and 25th and 75th quartiles. Statistical analysis was performed with the Wilcoxon ranked sum test. Results: The patients in the group without robotic assistance were significantly older and 4 had a body mass index over 30 versus none in the robotic group.
Robot (n510) No robot (n514) P value
OR time
Anesthesia
Procedure
366.5; 325,400 247.5; 210,305 ,0.001
355.0; 313,385 220.0, 195,240 ,0.001
289.0; 264,315 180.0; 150,210 ,0.001
EBL (ml)
RR
LOS
50.0; 25,50 10.0; 10,20 0.001
82.0; 60,125 65.0; 60,110 0.4
195.0; 180,220 185.0; 180,255 0.5
The robotic assistance group had a 50% pregnancy rate with all pregnancies delivered or ongoing. Follow-up hysterosalpingograms (HSG) in this group revealed patency in 17 of the 19 tubes. The HSG results and pregnancy rates are not yet available for the nonrobotic group but will be presented. Conclusion: Operatives times were very significantly longer with robotic assistance. This was predominantly due to the lack of tactile feedback during knot tying. Greater blood loss was also associated with the use of the robotic device.
P-168 Treatment of Deep Adenomyosis and Fertility Outcome with Cytoreductive Surgery (Myometrectomy) in a Group of Infertile Patients. A. Kenny, P. J. Buzzi, G. Van Thillo, G. Marconi, R. Quintana, E. Young. Instituto de Ginecologı´a y Fertilidad (IFER), Buenos Aires, Argentina. Objectives: Adenomyosis is a pathologic finding commonly related to impaired menstrual and reproductive characteristics in women. For those with a strong desire to preserve fertility, there is presently no uniform agreement on the most appropriate therapeutic method to manage this condition. The aim of the present paper is to report the results regarding fertility outcome in a group of infertile patients who underwent cytoreductive surgery of the uterus (Myometrectomy) due to severe adenomyosis. Design: Retrospective analysis of clinical and pregnancy outcome in women who underwent myometrectomy. Materials and Methods: Eight patients (30 – 41 years) who had sonographically diffusely enlarged uterus and/or distinctive myomata, symptomatic with dysmenorrhoea and menorraghia and otherwise unexplained infertility underwent a cytoreductive surgery and a subsequent four month course of gonadotropin-releasing hormone agonist(GnRHa) therapy. All patients had a laparoscopic procedure. Results: Two patients spontaneously became pregnant and delivered at full term. Six patients followed ovulation induction and IVF, and 5 patients conceived. There was one ectopic pregnancy, 1 twin pregnancy and 3 full term pregnancies. No major obstetric complications were observed. All patients reported improvement in menstrual symptoms at follow-up. Conclusions: 1) Restoring uterine architecture by myometrectomy has proven benefitial in terms of fertility as a conservative therapeutic method; 2) Laparoscopy is a useful and effective technique regarding surgery and obstetric outcomes; 3) Although etiology and pathogenic mechanisms responsible for adenomyosis are poor understood, impaired fertility in women
S148
Abstracts
with clinical adenomyosis may be facilitated by smooth muscle cell hyperplasia and hypertrophy secondary to ectopic endometrial proliferation and interfere with gamete transportation and/or implantation phenomena.
P-169 Preliminary Study of In Situ Treatment of Uterine Leiomyomata in the Eker Rat Using High Intensity Focused Ultrasound (HIFU). 1V. Y. Fujimoto, 2C. Walker, 3M. Paun, 4P. Nelson, 4S. Vaezy. 1Department of Obstetrics and Gynecology, 3Department of Surgery and 4Department of Bioengineering, University of Washington School of Medicine, Seattle, WA; and 2Department of Carcinogenesis, University of Texas M.D. Anderson Cancer Center, Smithsville, TX. Objectives: We are currently developing a non-invasive method of treatment for uterine fibroids using High Intensity Focused Ultrasound (HIFU). Previously, we demonstrated the efficacy of HIFU treatment in shrinking uterine fibroid tumors derived from the ELT-3 cell line injected into nude mice (ASRM #O-0140, 1999). In this study, our aims were (1) to utilize ultrasound imaging to monitor tumor size and real-time HIFU lesion formation and (2) to establish the viability of the Eker rat model for HIFU treatment. Design: Eker rats with documented uterine fibroid tumors underwent HIFU or sham treatments. Materials and Methods: Eight Eker rats (age 14 –16 months) with ultrasound-visible naturally-occurring uterine fibroid tumors were selected for this experiment. Animals were designated to one of two groups: (1) shamtreated group (n52) or (2) HIFU-treated group (n56). All animals underwent a laparotomy incision to expose the uterus and tumor. Tumor volume was calculated using caliper measurements of the long and short dimensions of the tumors. The range in volume of fibroid tumors varied from 0.06 –33.4 cm3. HIFU was administered using a 3.5 MHz transducer with an intensity of 2000 Watts/cm2. The laparotomy incision was closed and the animals were observed up to 15 weeks with weekly ultrasound examinations. After sacrifice, histological analyzes of tumors was conducted. Results: We observed a tumor volume reduction (mean 6 SD) in the HIFU-treated group of 82.1 6 7.7% (12 weeks after treatment) (n53). Two animals (HIFU treatment) and one animal (sham treatment) were euthanized prior to completion of the study due to renal carcinomas. The remaining sham-treated animal was noted to have continued growth of the uterine fibroid from 0.64 cm3 at the time of sham treatment to 5.43 cm3 at 15 weeks post-treatment (848% increase in volume). We were able to quantify tumor size reliably with ultrasound imaging. More importantly, simultaneous real-time ultrasound imaging of the HIFU treatments produced clear, distinct echogenic lesions at the HIFU focus within the fibroid tumors, which suggests focal necrosis. Conclusions: As a preliminary in situ study, we have shown a decrease in uterine fibroid volume in the Eker rat of 82.1% after a single HIFU treatment. These preliminary data strongly support the potential of HIFU as a non-invasive, bloodless therapy for uterine fibroid tumors in women. The ability to recognize lesion formation during HIFU treatment with real-time ultrasound provides further promise to the viability of this technology for clinical use. We are currently engaged in device development and safety studies to assess the feasibility of transvaginal HIFU in the clinical setting.
P-170 Obstetric Management and Prognosis after Hysteroscopic Metroplasty. 1 F. P. G. Leone, 1G. Ragusa, 2A. Bulfoni, 2S. Della Grazia, 1E. Ferrazzi, 2G. Pardi. 1Department of Obstetrics and Gynecology, ISBM L. Sacco and 2 Department of Obstetrics and Gynecology, DMCO S. Paolo, University of Milan, Medical School, Italy. Objective: To observe the obstetric management and prognosis of women undergone hysteroscopic treatment of septate uterus. Design: Prospective, observational study. Materials and Methods: Forty-six women with different degrees of septate uterus underwent hysteroscopic metroplasty at the Department of Obstetrics and Gynecology, DMCO S. Paolo, Milan. Of these, thirty-four patients had a history of previous miscarriages (median 2, range 1–5) (Group A), while 12 suffered primary infertility (Group B). In all cases the uterine septum was hysteroscopically removed. The presence of a residual
Vol. 74, No. 3, Suppl. 1, September 2000
No. good quality embryos
,35 years; 2 embryos transferred 0
1
2
table analysis. Eight retrospective studies were identified that compared treatment to no treatment and suggested that outcomes without intervention were comparable to those after resection. Conclusion: Recommendations (class C recommendations) for resection of a uterine septum are based on relatively weak data. No randomized, controlled trials were identified. Most studies showing efficacy were observational, of low power and with poor follow-up. No standard definition of a septate uterus could be identified. These results suggest the need for explicit, reliable evidence through randomized trials to identify patient profiles most likely to benefit from this surgery, appropriate risks and a standard definition for inclusion in such trials.
35–39 years; 3 embryos transferred 0
1
2
3
Cycles 11 35 180 21 55 87 230 Clinical preg2 (18.2) 11 (31.4) 68 (37.8) 4 (19) 14 (25.5) 35 (40.2) 78 (33.9) nancy (%) 1 sac (%) 2 8 (72.7) 50 (73.5) 4 (100) 9 (64.3) 19 (54.3) 51 (65.4) 2 sacs (%) – 3 (27.3) 18 (26.5) 0 (0) 5 (35.7) 13 (37.1) 21 (26.9) 3 sacs (%) – – – – – 3 (8.6) 6 (7.7) a 11.5 20.7b 16.1b Implantation (%) 9.1 20 23.8 6.3
P,0.05 a versus ba.
Implantation rates approached 20% following the transfer of one good quality embryo in women ,35 years & two good quality embryos in women between 35 and 39 years. Neither implantation nor pregnancy rates improved substantially beyond this threshold, despite the addition of one or two other embryos of variable quality. Small, but finite implantation rates of lesser quality embryos presumably accounted for the variability in implantation between groups. Conclusions: With implantation rates that approach or exceed 20%, these data support our decision to limit the number of embryos transferred. Furthermore, the data suggest that an additional reduction in the number of embryos transferred can be implemented without compromising pregnancy rates. We have eliminated trizygotic triplet gestations in women under 35 years in our program, and are encouraged by recent ASRM guidelines supporting limitation of embryo number.
REPRODUCTIVE SURGERY Monday, October 23, 2000
P-166 Reduction of Adhesion Reformation After Adhesiolysis in Pelvic Laparoscopy Using 4% Icodextrin Solution as an Intra-Operative Lavage and a Post-Operative Instillate. 1S. J. Verco, 2G. S. diZerega, 1E. M. Peers, the CLASSIC Study Group. 1ML Laboratories PLC, Blaby, Leicester, and 2University of Southern California, School of Medicine, Los Angeles, CA. Objective: Adhesion formation and reformation after abdominal surgery is a common occurrence with 34% of patients twice readmitted to hospital owing to adhesion-related problems during a ten year post-surgical period (Lancet, 1999; 353: 1476 – 80). Our aim was to assess the effect of a glucose polymer solution (4% icodextrin) on the reduction of adhesion formation and reformation in the abdominal surgery situation. Design: Sixty obstetric/gynecology patients requiring surgery (including adhesiolysis) for pelvic pain/fertility problems were recruited to an open, parallel group, five centre, randomized study. Materials and Methods: 4% icodextrin solution (Adept™) or Ringer lactate solution (RLS) were administered $100 ml per 30 minutes intraoperatively followed by 1L post-procedure via intraperitoneal laparoscope. A second-look procedure was undertaken 6 –12 weeks later. The interim data from 30 completed patient procedures have been analyzed for efficacy (n525) using the mAFS (modified American Fertility Society) score for incidence, extent and severity of post-operative adhesions, and for tolerability (n530). Results are presented from 17 adhesiolysis procedures (4% icodextrin, n59; RLS, n58). Results: There were no adverse events related to study treatments. Mean % reduction (SD) in adhesion number per patient was 60.5% (38.9) for icodextrin and 22.7% (164.3) for RLS treated patients. The tabulated data represent adhesion extent and reformation:
P-165 Assessing the Quality of Evidence in Support of Resection of a Uterine Septum. G. S. Letterie. Center for Fertility and Reproductive Endocrinology, Virginia Mason Medical Center, Seattle, WA. Objectives: Though well entrenched as a recommended therapy in select circumstances, the rationale and strength for resection of a uterine septum remains unclear. The purpose of the present study was to evaluate the quality of evidence in support of resection of a uterine septum using an evidence based approach. Design: Survey of published trials describing outcomes after treatment of septate uterus. Data Sources: A search of MEDLINE database of English-language journals was performed to locate relevant articles published between 1985 and 1999. Original research and review articles were included. Abstracts at scientific conferences were not. Additional studies were located by handsearching bibliographies of articles retrieved in the search. Main Outcomes Measures: Publications were reviewed for study design, inclusion of any definition of septate uterus and postoperative evaluation of the endometrial cavity. The data describing study design were classified using the rating system of the U.S. Preventive Services Task Force. Results: One hundred and ten articles were reviewed. No standard, quantitative definition of a septate uterus was identified. Twenty-five articles included both septate and arcuate uterus in the study groups. There were no randomized, prospective studies evaluating the efficacy of this surgery. Most studies were observational using treated patients as their own controls and limited case series (class II-3 and III evidence). Thirty-five percent of the articles included evaluation of the uterine cavity after resection either with hysterosalpingography or hysteroscopy. Three percent included a life
FERTILITY & STERILITYt
4% icodextrin RLS
No. adhesions at 1st surgery (SD)
No. adhesions at 2nd surgery (SD)
Extent % reduction (SD) [mean per patient]
% Reformation (SD) [mean per patient]
5.4 (3.8) 3.8 (3.2)
1.7 (2.9) 1.3 (1.5)
65.8 (33.3) 22.5 (165.5)
17.7 (26.6) 39.6 (43.0)
Conclusion: The results of the interim analysis of this pilot study indicate that 4% icodextrin is well tolerated by patients, and reduces adhesion formation and reformation after abdominal surgery when used as a wash during the surgical procedure and as a post-operative instillate. This research was supported by ML Laboratories PLC, UK.
P-167 Laparoscopic Tubal Anastomosis With and Without Robotic Assistance. J. M. Goldberg, T. Falcone. Department of Gynecology and Obstetrics, The Cleveland Clinic Foundation, Cleveland, OH. Objective: The objective was to compare procedure duration, length of hospitalization and estimated blood loss for laparoscopic tubal anastomosis performed with and without laparoscopic assistance. Design: A retrospective chart review of all laparoscopic tubal anastomoses excluding 2 cornual repairs was performed. Materials and Methods: Outpatient laparoscopic tubal anastomosis was performed on 24 patients with the same technique used at laparotomy. After opening the occluded segments, the mesosalpinx was reapproximated with an interrupted 6-0 delayed absorbable suture. The anastomosis was per-
S147
formed by placing 4 interrupted 8-0 delayed absorbable sutures incorporating the muscularis and mucosal layers. The serosa was also closed with interrupted 8-0 delayed absorbable sutures. No stents were used. Tubal patency was demonstrated intraoperatively. The first 10 procedures were performed with robotic assistance using the Zeus system (Computer Motion, Santa Barbara, CA) for the laparoscopic suturing. The surgeon was seated at a console with a video monitor and manipulated the handles which translated the movements to the instruments. The subsequent 14 cases were performed without the robot with each surgeon serving as 1 “hand” for laparoscopic knot tying. The total operating room (OR), anesthesia and actual procedure times were recorded as well as the estimated blood loss (EBL), time in the recovery room (RR) and total length of stay (LOS). All times are in minutes and the results are reported as the median and 25th and 75th quartiles. Statistical analysis was performed with the Wilcoxon ranked sum test. Results: The patients in the group without robotic assistance were significantly older and 4 had a body mass index over 30 versus none in the robotic group.
Robot (n510) No robot (n514) P value
OR time
Anesthesia
Procedure
366.5; 325,400 247.5; 210,305 ,0.001
355.0; 313,385 220.0, 195,240 ,0.001
289.0; 264,315 180.0; 150,210 ,0.001
EBL (ml)
RR
LOS
50.0; 25,50 10.0; 10,20 0.001
82.0; 60,125 65.0; 60,110 0.4
195.0; 180,220 185.0; 180,255 0.5
The robotic assistance group had a 50% pregnancy rate with all pregnancies delivered or ongoing. Follow-up hysterosalpingograms (HSG) in this group revealed patency in 17 of the 19 tubes. The HSG results and pregnancy rates are not yet available for the nonrobotic group but will be presented. Conclusion: Operatives times were very significantly longer with robotic assistance. This was predominantly due to the lack of tactile feedback during knot tying. Greater blood loss was also associated with the use of the robotic device.
P-168 Treatment of Deep Adenomyosis and Fertility Outcome with Cytoreductive Surgery (Myometrectomy) in a Group of Infertile Patients. A. Kenny, P. J. Buzzi, G. Van Thillo, G. Marconi, R. Quintana, E. Young. Instituto de Ginecologı´a y Fertilidad (IFER), Buenos Aires, Argentina. Objectives: Adenomyosis is a pathologic finding commonly related to impaired menstrual and reproductive characteristics in women. For those with a strong desire to preserve fertility, there is presently no uniform agreement on the most appropriate therapeutic method to manage this condition. The aim of the present paper is to report the results regarding fertility outcome in a group of infertile patients who underwent cytoreductive surgery of the uterus (Myometrectomy) due to severe adenomyosis. Design: Retrospective analysis of clinical and pregnancy outcome in women who underwent myometrectomy. Materials and Methods: Eight patients (30 – 41 years) who had sonographically diffusely enlarged uterus and/or distinctive myomata, symptomatic with dysmenorrhoea and menorraghia and otherwise unexplained infertility underwent a cytoreductive surgery and a subsequent four month course of gonadotropin-releasing hormone agonist(GnRHa) therapy. All patients had a laparoscopic procedure. Results: Two patients spontaneously became pregnant and delivered at full term. Six patients followed ovulation induction and IVF, and 5 patients conceived. There was one ectopic pregnancy, 1 twin pregnancy and 3 full term pregnancies. No major obstetric complications were observed. All patients reported improvement in menstrual symptoms at follow-up. Conclusions: 1) Restoring uterine architecture by myometrectomy has proven benefitial in terms of fertility as a conservative therapeutic method; 2) Laparoscopy is a useful and effective technique regarding surgery and obstetric outcomes; 3) Although etiology and pathogenic mechanisms responsible for adenomyosis are poor understood, impaired fertility in women
S148
Abstracts
with clinical adenomyosis may be facilitated by smooth muscle cell hyperplasia and hypertrophy secondary to ectopic endometrial proliferation and interfere with gamete transportation and/or implantation phenomena.
P-169 Preliminary Study of In Situ Treatment of Uterine Leiomyomata in the Eker Rat Using High Intensity Focused Ultrasound (HIFU). 1V. Y. Fujimoto, 2C. Walker, 3M. Paun, 4P. Nelson, 4S. Vaezy. 1Department of Obstetrics and Gynecology, 3Department of Surgery and 4Department of Bioengineering, University of Washington School of Medicine, Seattle, WA; and 2Department of Carcinogenesis, University of Texas M.D. Anderson Cancer Center, Smithsville, TX. Objectives: We are currently developing a non-invasive method of treatment for uterine fibroids using High Intensity Focused Ultrasound (HIFU). Previously, we demonstrated the efficacy of HIFU treatment in shrinking uterine fibroid tumors derived from the ELT-3 cell line injected into nude mice (ASRM #O-0140, 1999). In this study, our aims were (1) to utilize ultrasound imaging to monitor tumor size and real-time HIFU lesion formation and (2) to establish the viability of the Eker rat model for HIFU treatment. Design: Eker rats with documented uterine fibroid tumors underwent HIFU or sham treatments. Materials and Methods: Eight Eker rats (age 14 –16 months) with ultrasound-visible naturally-occurring uterine fibroid tumors were selected for this experiment. Animals were designated to one of two groups: (1) shamtreated group (n52) or (2) HIFU-treated group (n56). All animals underwent a laparotomy incision to expose the uterus and tumor. Tumor volume was calculated using caliper measurements of the long and short dimensions of the tumors. The range in volume of fibroid tumors varied from 0.06 –33.4 cm3. HIFU was administered using a 3.5 MHz transducer with an intensity of 2000 Watts/cm2. The laparotomy incision was closed and the animals were observed up to 15 weeks with weekly ultrasound examinations. After sacrifice, histological analyzes of tumors was conducted. Results: We observed a tumor volume reduction (mean 6 SD) in the HIFU-treated group of 82.1 6 7.7% (12 weeks after treatment) (n53). Two animals (HIFU treatment) and one animal (sham treatment) were euthanized prior to completion of the study due to renal carcinomas. The remaining sham-treated animal was noted to have continued growth of the uterine fibroid from 0.64 cm3 at the time of sham treatment to 5.43 cm3 at 15 weeks post-treatment (848% increase in volume). We were able to quantify tumor size reliably with ultrasound imaging. More importantly, simultaneous real-time ultrasound imaging of the HIFU treatments produced clear, distinct echogenic lesions at the HIFU focus within the fibroid tumors, which suggests focal necrosis. Conclusions: As a preliminary in situ study, we have shown a decrease in uterine fibroid volume in the Eker rat of 82.1% after a single HIFU treatment. These preliminary data strongly support the potential of HIFU as a non-invasive, bloodless therapy for uterine fibroid tumors in women. The ability to recognize lesion formation during HIFU treatment with real-time ultrasound provides further promise to the viability of this technology for clinical use. We are currently engaged in device development and safety studies to assess the feasibility of transvaginal HIFU in the clinical setting.
P-170 Obstetric Management and Prognosis after Hysteroscopic Metroplasty. 1 F. P. G. Leone, 1G. Ragusa, 2A. Bulfoni, 2S. Della Grazia, 1E. Ferrazzi, 2G. Pardi. 1Department of Obstetrics and Gynecology, ISBM L. Sacco and 2 Department of Obstetrics and Gynecology, DMCO S. Paolo, University of Milan, Medical School, Italy. Objective: To observe the obstetric management and prognosis of women undergone hysteroscopic treatment of septate uterus. Design: Prospective, observational study. Materials and Methods: Forty-six women with different degrees of septate uterus underwent hysteroscopic metroplasty at the Department of Obstetrics and Gynecology, DMCO S. Paolo, Milan. Of these, thirty-four patients had a history of previous miscarriages (median 2, range 1–5) (Group A), while 12 suffered primary infertility (Group B). In all cases the uterine septum was hysteroscopically removed. The presence of a residual
Vol. 74, No. 3, Suppl. 1, September 2000