Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice

Vanessa L. Jacoby, Ram Parvataneni, Erica Oberman, Naghmeh Salamat Saberi, Shira Varon, Michael Schembri, L. Elaine Waetjen

Research output: Contribution to journalArticle

Abstract

Study Objective: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. Design: Uncontrolled clinical trial. Setting: Five academic medical centers across California. Patients: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. Interventions: Laparoscopic RFA of leiomyomas. Measurements and Main Results: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4–7.5) on a 10-point scale, and 89% of surgeons felt “very or somewhat” confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2–6) after the fourth procedure, with all gynecologists reporting surgical confidence. Conclusion: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.

Original languageEnglish (US)
JournalJournal of Minimally Invasive Gynecology
DOIs
StateAccepted/In press - Jan 1 2019

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Leiomyoma
Intraoperative Complications
Confidence Intervals
Operative Time
Insurance
Uterus
Quality of Life
Clinical Trials
Hemorrhage

Keywords

  • Laparoscopy
  • Leiomyomas
  • Radiofrequency ablation

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas : Clinical Outcomes during Early Adoption into Surgical Practice. / Jacoby, Vanessa L.; Parvataneni, Ram; Oberman, Erica; Saberi, Naghmeh Salamat; Varon, Shira; Schembri, Michael; Waetjen, L. Elaine.

In: Journal of Minimally Invasive Gynecology, 01.01.2019.

Research output: Contribution to journalArticle

Jacoby, Vanessa L. ; Parvataneni, Ram ; Oberman, Erica ; Saberi, Naghmeh Salamat ; Varon, Shira ; Schembri, Michael ; Waetjen, L. Elaine. / Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas : Clinical Outcomes during Early Adoption into Surgical Practice. In: Journal of Minimally Invasive Gynecology. 2019.
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abstract = "Study Objective: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. Design: Uncontrolled clinical trial. Setting: Five academic medical centers across California. Patients: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. Interventions: Laparoscopic RFA of leiomyomas. Measurements and Main Results: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74{\%} of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47{\%}, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95{\%} confidence interval [CI], 4–7.5) on a 10-point scale, and 89{\%} of surgeons felt “very or somewhat” confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95{\%} CI, 1.2–6) after the fourth procedure, with all gynecologists reporting surgical confidence. Conclusion: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.",
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AB - Study Objective: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. Design: Uncontrolled clinical trial. Setting: Five academic medical centers across California. Patients: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. Interventions: Laparoscopic RFA of leiomyomas. Measurements and Main Results: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4–7.5) on a 10-point scale, and 89% of surgeons felt “very or somewhat” confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2–6) after the fourth procedure, with all gynecologists reporting surgical confidence. Conclusion: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.

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