Abstract
OBJECTIVE: To observe and assess the efficacy and safety of this new cervical dilator device, for the first time in humans. Thus, if the study is successful, raise a second phase through a randomized clinical trial, which purpose shall be to show if there is a superiority of this device with respect to common mechanics dilators.
MATERIALS AND METHODS: prospective, experimental intervention study, in patients undergoing gynecological diagnostic and therapeutic procedures, requiring cervical dilatation, using the Aqueduct - 100®, the Hospital General Santa María del Puerto (Spain). The study included 50 patients who met the criteria for inclusion, in the period January-December 2015.
RESULTS: the mean age of the patients was 52.6 years. They were divided into two treatment groups: 38 patients were subjected to a process of expansion of 5 minutes and 12 3-minute processes. The description of the most frequent procedure was the realization of a diagnostic Hysteroscopy (44%). The cervical diameter medium, both initial and subsequent procedure was 2.8 and 7.7 mm, respectively. The valuation of the device by the specialists who used it, ranged between good and excellent rating for all items. There was no complication associated with the process of cervical dilatation with the device.
CONCLUSIONS: The Aqueduct - 100® device can be a simple and effective alternative to perform cervical dilatation maneuvers necessary for performing gynecological procedures, intrauterine and endometrial level.
KEY WORDS: Cervix; Cervical dilation; Balloon catheter; Hysteroscopy; Curettage
