Learning hysteroscopy sterilization and the Ovabloc System with Hyskon
Loffer, F.D.; Loffer, P.S.
Acta Europaea Fertilitatis 17(6): 477-480
1986
ISSN/ISBN: 0587-2421 PMID: 3630560 Document Number: 352017
The first 100 (group 1) and the last 100 patients (group 2) in a series of 268 patients sterilized by hysteroscopic injection of liquid silicone into the fallopian tube were compared to evaluate the success rate as it relates to experience with the procedure. Hysteroscopic experience is a prerequisite for this procedure, and approximately 150 surgical and diagnostic cases had been performed prior to starting this procedure. Most of these were done using general anesthesia. The surgeon's training for use of the Ovabloc System consisted of 2 half-days with the senior investigator. These sessions consisted of observing 2 actual cases and injecting silicone plugs into several extripated uteri. The nurse's training consisted of participating in the surgeon's visit for the 2 half-day sessions as well as a 2-day on-site instruction. 45 months elapsed between the 1st and last cases studied. No major instrument, procedure, or material changes were made except for the introduction of a softer catheter guide and an insulated container to hold the dispensing syringe during mixing. There was little difference between the 2 groups of patients in regard to age or parity. The minimum followup on all patients was 12 months. 1 patient had been lost to followup in group 1 after 24 months and another in group 2 after 12 months. There was only 1 pregnancy in the entire series, an ectopic pregnancy which occurred in a patient from group 2 who was found to have bilateral abnormal plugs at the post-insertion x-ray. 91 patients were sterilized in group 1 as compared with 94 in group 2. 18 patients in the 1st group had multiple procedures (13 successfully) versus only 9 (7 successfully) in the 2nd group. 22 of the 29 repeat procedures (75.9%) were caused by: either a failure of the pre-formed tip to weld to the formed in-place plug which allowed the plugs to fall out of the tube; or by tubal spasm which precluded introduction of the silicone material. The 1st problem may become less of a problem with new manufacturing changes. Tubal spasm was lessened as a problem by controlling the temperature of Hyskon, but it continues to be a difficult problem in a smaller number of patients. Other causes for repeated procedures include problems related to operator inexperience and investigational problems but appear not to pose a significant problem for physicians who will learn this procedure in the future. The mean time for performing the procedure improved with experience but the range remained unchanged. More patients were judged to have tolerated the procedure poorly in the 2nd group, but this may reflect increased critical awareness on the part of the nursing assistant. There were no significant complications in either group of patients.