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Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Fibroids and Myomectomy: A Randomized Trial of Uterine-Sparing Techniques in Canada
Abstracts / Journal of Minimally Invasive Gynecology 21 (2014) S91–S135 Mean parity =3.2 Nulliparty = 68 (5%) Multiparity = 1332 (95%) Previous abdominal surgery = 240 (16.5%) Minimal uterine descent = 1308 (90%) Previous caesarean section: 208 (14.8%) Caesarean section x1 = 122(60.2%) Caesarean section x2 = 54 (25%) Caesarean section x3 = 32 (14.8%). Measurements and Main Results: Total cases = 1400 Abdominal Hysterectomy = 250 Conversion to TAH = 33 (2.4%) Successful vaginal hysterectomy = 1117 (79.8%) Duration of stay in hospital (mean) = 2.8 days Mean weight of uterus = 120 gm Ave. weight of patient = 77 kg COMPLICATIONS: Pelvic infection - 16 cases (1.3%); Retro peritoneal haematoma - 11 cases (1.0%); Vault haematoma - 6 cases (0.5%); Ureteric injury - 0 cases (0%); Bladder injury - 8 cases (0.8%); Complications related to: Laparoscopy - 0 cases (0%); Vault abscess - 6 cases (0.5%); Sub-acute bowel obstruction - 1 cases (0.1%). Conclusion: VH can be performed successfully in women with relative contra-indications and with enlarged uteri. It is significantly cheaper than TLH, with minimal complications. Hence, VH should be the choice operative procedure. 336
Open Communications 18 - Advanced Endoscopy (4:14 PM - 4:19 PM)
Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Fibroids and Myomectomy: A Randomized Trial of Uterine-Sparing Techniques in Canada Thiel JA,1 Rattray DD,1 Leyland N.2 1Regina General Hospital, Regina, Saskatchewan, Canada; 2Women’s Reproductive Health Program, McMaster University Health Clinic, Hamilton, Ontario, Canada Study Objective: Evaluate the health outcomes, complications, and re-interventions for subjects randomized to either ultrasound-guided myomectomy (abdominal or laparoscopic) or RFVTA. Design: Post-market, randomized (1:1), prospective, longitudinal comparative study. Setting: Provincial hospital in Saskatchewan, Canada and university hospital in Ontario, Canada. Patients: Thirty premenopausal women R18 years old with symptomatic fibroids who desired uterine conservation and preservation of fertility and who were indicated for surgical intervention for their fibroid symptoms. Intervention: Laparoscopic or abdominal myomectomy or RFVTA. Measurements and Main Results: Consented subjects were randomized (1:1) to myomectomy (n=15) or RFVTA (n=14); one subject withdrew from the study before treatment. All myomectomies were carried out laparoscopically. Postoperatively, at 6 months follow up, Uterine Fibroid Symptom Severity scores improved (decreased) from baseline by 57.3% for the RFVTA group (n=11) and by 61.2% for the myomectomy group (n=10) and Health-Related Quality-of-Life scores improved (increased) by 75.3% and 70.4% for the RFVTA and myomectomy subjects, respectively. Likewise, general health-state scores improved (increased) from baseline by 31.2% and by 12.2% for RFVTA and myomectomy subjects, respectively. In response to the Menstrual Impact Questionnaire at 6 months, 45.5% of RFVTA subjects and 40.0% of myomectomy subjects reported heavy or very heavy bleeding. At 6 months, 54.5% and 50.0% of RFVTA and myomectomy respondents, respectively, reported being very satisfied with their treatment; 45.5% and 30.0% of the respondents, respectively, thought their treatment effective in eliminating their fibroid symptoms. Last, 81.8% of RFVTA subjects thought their fibroid symptoms had improved versus 60.0% of myomectomy subjects. No RFVTA subjects reported complications; two myomectomy subjects reported serious or severe complications: cardiac arrest (n=1) and wound infection and pain (n=1). Intraoperatively, one myomectomy was
S101
converted to the abdominal approach. One RFVTA subject underwent total laparoscopic hysterectomy due to a return of symptoms. Conclusion: In this small cohort of women, RFVTA provided equivalent-tosuperior efficacy and safety outcomes compared to laparoscopic myomectomy.
337
Open Communications 18 - Advanced Endoscopy (4:20 PM - 4:25 PM)
The Surgical Outcomes of Transumbilical Single-Site Laparoscopic Myomectomy Using Straight Instruments Yen C-F, Han C-M, Huang C-Y, Lee C-L. Obstetrics and Gynecology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan Study Objective: To evaluate the accessibility of transumbilical single-port laparoscopy using conventional straight instruments for myomectomy. Design: Prospective observational study. Setting: Tertiary referral medical center. Patients: From April 2011 to April 2012, consecutive patients scheduled for laparoscopic myomectomy. Intervention: Using conventional, straight instruments and laparoscope, myomectomy and suture repair were performed with transumbilical single-port approach with or without ancillary port. All the specimens were removed by manual morcellation from the umbilical wound. Measurements and Main Results: Total 59 patients were included, with mean(SEM) age 38.50.9 years and mean body mass index 22.00.4 kg/m2. Yielded mean myoma weight was 186.931.8 gm, with 21 (35.6%) weighing >200 gm, including 3 specimens >1000gm, and 18 (30.5%) needed concurrent adhesiolysis. Operations with retrieved myomas >200 gm, in comparison with those with myomas %200gm, had longer operating time (188.016.2 min vs. 134.39.5 min; p\0.05), higher intraoperative blood loss (326.471.2 ml vs. 183.042.8 ml; p\0.05), and longer postoperative hospital stay (3.10.2 days vs. 2.20.1 days; p\0.05). Four (6.8%) patients needed transfusion in the current study. In the first half of the present study, 21 of the 30 patients (70.0%) needed an ancillary trocar; however, the rate of needing ancillary trocar decreased to 31.0% (9/29) in the later half. There was no major intraoperative or postoperative complication. Conclusion: Single-port laparoscopic myomectomy using conventional straight instruments is generally technical demanding and time consuming. Though patients were beneficial with less abdominal wound, ancillary trocar may be required in one third of the patients for surgical quality. Patients with larger myoma tended to have more intraoperative blood loss, longer operating time, and perhaps longer hospital stay.
338
Open Communications 18 - Advanced Endoscopy (4:26 PM - 4:31 PM)
Experience with Laparoscopic Hysterectomy in a Single Ambulatory Surgical Center from October 2005-March 2014 Engel SE,1 Rosenfield R.2 1Legacy Good Samaritan Medical Center, Portland, Oregon; 2Pearl Women’s Center, Portland, Oregon Study Objective: This study describes the surgical experience with laparoscopic hysterectomy at a single, metropolitan ambulatory surgical center. Design: Retrospective chart review. Setting: Single ambulatory surgical center in Portland, OR. Patients: Consecutive patients (n=819) undergoing laparoscopic hysterectomy between October 2005 and March 2014. Intervention: Laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) performed on an outpatient basis with same-day discharge. Measurements and Main Results: Laparoscopic hysterectomy was performed in 819 women (LSH =705, TLH = 114) between October 2005 and March 2014 in an outpatient surgical center with same-day discharge home. The average patient age was 44 years old (range 19-64 years). The average operative time was 107.9 minutes (range 64-235 minutes). Eight patients (0.01%) required hospital transfer for peri-operative complications.
Open Communications 18 - Advanced Endoscopy (4:14 PM - 4:19 PM)
Laparoscopic Radiofrequency Volumetric Thermal Ablation (RFVTA) of Symptomatic Fibroids and Myomectomy: A Randomized Trial of Uterine-Sparing Techniques in Canada Thiel JA,1 Rattray DD,1 Leyland N.2 1Regina General Hospital, Regina, Saskatchewan, Canada; 2Women’s Reproductive Health Program, McMaster University Health Clinic, Hamilton, Ontario, Canada Study Objective: Evaluate the health outcomes, complications, and re-interventions for subjects randomized to either ultrasound-guided myomectomy (abdominal or laparoscopic) or RFVTA. Design: Post-market, randomized (1:1), prospective, longitudinal comparative study. Setting: Provincial hospital in Saskatchewan, Canada and university hospital in Ontario, Canada. Patients: Thirty premenopausal women R18 years old with symptomatic fibroids who desired uterine conservation and preservation of fertility and who were indicated for surgical intervention for their fibroid symptoms. Intervention: Laparoscopic or abdominal myomectomy or RFVTA. Measurements and Main Results: Consented subjects were randomized (1:1) to myomectomy (n=15) or RFVTA (n=14); one subject withdrew from the study before treatment. All myomectomies were carried out laparoscopically. Postoperatively, at 6 months follow up, Uterine Fibroid Symptom Severity scores improved (decreased) from baseline by 57.3% for the RFVTA group (n=11) and by 61.2% for the myomectomy group (n=10) and Health-Related Quality-of-Life scores improved (increased) by 75.3% and 70.4% for the RFVTA and myomectomy subjects, respectively. Likewise, general health-state scores improved (increased) from baseline by 31.2% and by 12.2% for RFVTA and myomectomy subjects, respectively. In response to the Menstrual Impact Questionnaire at 6 months, 45.5% of RFVTA subjects and 40.0% of myomectomy subjects reported heavy or very heavy bleeding. At 6 months, 54.5% and 50.0% of RFVTA and myomectomy respondents, respectively, reported being very satisfied with their treatment; 45.5% and 30.0% of the respondents, respectively, thought their treatment effective in eliminating their fibroid symptoms. Last, 81.8% of RFVTA subjects thought their fibroid symptoms had improved versus 60.0% of myomectomy subjects. No RFVTA subjects reported complications; two myomectomy subjects reported serious or severe complications: cardiac arrest (n=1) and wound infection and pain (n=1). Intraoperatively, one myomectomy was
S101
converted to the abdominal approach. One RFVTA subject underwent total laparoscopic hysterectomy due to a return of symptoms. Conclusion: In this small cohort of women, RFVTA provided equivalent-tosuperior efficacy and safety outcomes compared to laparoscopic myomectomy.
337
Open Communications 18 - Advanced Endoscopy (4:20 PM - 4:25 PM)
The Surgical Outcomes of Transumbilical Single-Site Laparoscopic Myomectomy Using Straight Instruments Yen C-F, Han C-M, Huang C-Y, Lee C-L. Obstetrics and Gynecology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan Study Objective: To evaluate the accessibility of transumbilical single-port laparoscopy using conventional straight instruments for myomectomy. Design: Prospective observational study. Setting: Tertiary referral medical center. Patients: From April 2011 to April 2012, consecutive patients scheduled for laparoscopic myomectomy. Intervention: Using conventional, straight instruments and laparoscope, myomectomy and suture repair were performed with transumbilical single-port approach with or without ancillary port. All the specimens were removed by manual morcellation from the umbilical wound. Measurements and Main Results: Total 59 patients were included, with mean(SEM) age 38.50.9 years and mean body mass index 22.00.4 kg/m2. Yielded mean myoma weight was 186.931.8 gm, with 21 (35.6%) weighing >200 gm, including 3 specimens >1000gm, and 18 (30.5%) needed concurrent adhesiolysis. Operations with retrieved myomas >200 gm, in comparison with those with myomas %200gm, had longer operating time (188.016.2 min vs. 134.39.5 min; p\0.05), higher intraoperative blood loss (326.471.2 ml vs. 183.042.8 ml; p\0.05), and longer postoperative hospital stay (3.10.2 days vs. 2.20.1 days; p\0.05). Four (6.8%) patients needed transfusion in the current study. In the first half of the present study, 21 of the 30 patients (70.0%) needed an ancillary trocar; however, the rate of needing ancillary trocar decreased to 31.0% (9/29) in the later half. There was no major intraoperative or postoperative complication. Conclusion: Single-port laparoscopic myomectomy using conventional straight instruments is generally technical demanding and time consuming. Though patients were beneficial with less abdominal wound, ancillary trocar may be required in one third of the patients for surgical quality. Patients with larger myoma tended to have more intraoperative blood loss, longer operating time, and perhaps longer hospital stay.
338
Open Communications 18 - Advanced Endoscopy (4:26 PM - 4:31 PM)
Experience with Laparoscopic Hysterectomy in a Single Ambulatory Surgical Center from October 2005-March 2014 Engel SE,1 Rosenfield R.2 1Legacy Good Samaritan Medical Center, Portland, Oregon; 2Pearl Women’s Center, Portland, Oregon Study Objective: This study describes the surgical experience with laparoscopic hysterectomy at a single, metropolitan ambulatory surgical center. Design: Retrospective chart review. Setting: Single ambulatory surgical center in Portland, OR. Patients: Consecutive patients (n=819) undergoing laparoscopic hysterectomy between October 2005 and March 2014. Intervention: Laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) performed on an outpatient basis with same-day discharge. Measurements and Main Results: Laparoscopic hysterectomy was performed in 819 women (LSH =705, TLH = 114) between October 2005 and March 2014 in an outpatient surgical center with same-day discharge home. The average patient age was 44 years old (range 19-64 years). The average operative time was 107.9 minutes (range 64-235 minutes). Eight patients (0.01%) required hospital transfer for peri-operative complications.