SAN FRANCISCO, May 11-An in-office tubal sterilization and an endometrial ablation can be performed in one session without compromising either procedure, researchers reported here today.
"Physicians may want to combine the procedures because many women who would benefit from endometrial ablation are also of childbearing age," according to Rafael F. Valle, M.D., of Northwestern.
"If sterilization is an appropriate choice for them, it is feasible to perform the two procedures in one session, and more convenient for patients," Dr. Valle reported at the American College of Obstetrics and Gynecology meeting here.
Action Points
- This preliminary study suggests that the FDA-approved combination approach is feasible and may be more convenient for patients and physicians.
- The study appears to show that the hyperthermia used in endometrial ablation was safe for the tubal occlusion devices, and that the occlusion devices did not interfere with the ablation procedure.
- This study was published as an abstract and presented at a conference either as an oral or poster presentation. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
To determine whether it is safe and effective to combine the microinsertion tubal occlusion procedure (Essure) with thermal endometrial ablation (ThermaChoice III), an FDA-approved combination, the investigators recruited 40 women who had been referred for hysterectomies due to benign uterine bleeding. None of the women had any other intrauterine pathology, and they agreed to volunteer for the two procedures immediately before their scheduled hysterectomies.
A cause for concern was whether the heated fluid used to destroy the endometrium would affect the occlusive devices in the fallopian tubes and surrounding organs. Therefore, the investigators placed thermocouples along the serosa of the proximal tubes and uterus after placing the tubal occlusive devices in order to assess the temperature at those sites.
The measured temperatures turned out to be an average of 37.1 to 37.5o C, and in no patient did they reach 45o C, the limit of safety for the occlusive devices. Dr. Valle's team also found no tissue damage in the tubes.
In the post-hysterectomy evaluations by the treating physicians and the pathology department at the study hospital, the team found no disturbance of the occlusive devices, while the endometrial ablation, assessed visually and histologically, proved complete and uniform. Although small areas near the tubal ostea showed less destruction, other investigators had seen that discrepancy in thermal ablation without concomitant tubal occlusion.
Tubal occlusion consists of placing occlusive devices at the openings of the fallopian tubes. The endometrial ablation procedure involves inserting a balloon catheter into the uterine cavity and ablating the uterine lining by instilling fluid into the balloon that contains a heating element, and then heating the fluid to destroy the endometrium by hyperthermia.
Dr. Valle noted that, on the basis of these and other findings, the FDA had approved the combined procedure. Each had previously been approved separately.
Primary Source
American College of Obstetrics-Gynecology, 53rd annual meeting, p. 6S of abstract book.
Source Reference: American Academy of Obstetrics-Gynecology' 53rd annual meeting: Valle RF. Concomitant ESSURE Tubal Sterilization and ThermaChoice Endometrial Ablation: Feasibility and Safety. P. 6S of abstract book.