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

doi:10.1016/j.jmig.2019.07.025

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

J Minim Invasive Gynecol. 2020 May-Jun;27(4):915-925. doi: 10.1016/j.jmig.2019.07.025. Epub 2019 Jul 31.

Authors

Vanessa L Jacoby¹, Ram Parvataneni², Erica Oberman², Naghmeh Salamat Saberi², Shira Varon², Michael Schembri², L Elaine Waetjen²

Affiliations

¹ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California (Dr. Jacoby and M. Schembri); Department of Obstetrics and Gynecology, University of California Los Angeles, Los Angeles, California (Drs. Parvataneni and Oberman); Department of Obstetrics and Gynecology, University of California Irvine, Irvine, California (Dr. Salamat Saberi); Department of Obstetrics and Gynecology, University of California San Diego, La Jolla, California (Dr. Varon); Department of Obstetrics and Gynecology, University of California Davis, Davis, California (Dr. Waetjen); University of California Fibroid Network (Drs. Jacoby, Parvataneni, Oberman, Varon, Schembri, and Waetjen). Electronic address: Vanessa.Jacoby@ucsf.edu.
² Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California (Dr. Jacoby and M. Schembri); Department of Obstetrics and Gynecology, University of California Los Angeles, Los Angeles, California (Drs. Parvataneni and Oberman); Department of Obstetrics and Gynecology, University of California Irvine, Irvine, California (Dr. Salamat Saberi); Department of Obstetrics and Gynecology, University of California San Diego, La Jolla, California (Dr. Varon); Department of Obstetrics and Gynecology, University of California Davis, Davis, California (Dr. Waetjen); University of California Fibroid Network (Drs. Jacoby, Parvataneni, Oberman, Varon, Schembri, and Waetjen).

PMID: 31376584
DOI: 10.1016/j.jmig.2019.07.025

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.

Keywords: Laparoscopy; Leiomyomas; Radiofrequency ablation.

Publication types

Clinical Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
California / epidemiology
Clinical Competence / statistics & numerical data
Education, Medical, Continuing / statistics & numerical data
Education, Medical, Continuing / trends
Female
Gynecologic Surgical Procedures* / education
Gynecologic Surgical Procedures* / methods
Gynecologic Surgical Procedures* / statistics & numerical data
Gynecologic Surgical Procedures* / trends
Humans
Intraoperative Complications / epidemiology
Intraoperative Complications / etiology
Laparoscopy / adverse effects
Laparoscopy / education
Laparoscopy / methods*
Laparoscopy / statistics & numerical data
Learning Curve
Leiomyoma / epidemiology
Leiomyoma / pathology
Leiomyoma / surgery*
Middle Aged
Operative Time
Practice Patterns, Physicians' / statistics & numerical data
Practice Patterns, Physicians' / trends
Quality of Life
Radiofrequency Ablation / adverse effects
Radiofrequency Ablation / methods*
Radiofrequency Ablation / statistics & numerical data
Treatment Outcome
Uterine Neoplasms / epidemiology
Uterine Neoplasms / pathology
Uterine Neoplasms / surgery*
Young Adult