Randomized Clinical Trial of a new Anti–Cervical Stenosis Device after Conization by Loop Electrosurgical Excision v1

Background: The complications inherent to conization include vaginal bleeding, cervical stenosis, amenorrhea, dysmenorrhea, and deep dyspareunia. Cervical stenosis is the most critical complication due to clinical repercussions. Studies show rates of cervical stenosis ranging from 1.3 to 19% after LEEP. Objective: Randomized controlled trial (RCT) data is need comparing the use of a new anti-stenosis cervical device in the treatment of cervical precursor lesions. Our primary outcome was to compare the role of a new endocervical device to prevent cervical stenosis after LEEP in patients with high-grade squamous intraepithelial lesions (HSILs) by the conduct of a randomized clinical trial. Study design: According to the standards of randomized clinical trials, we performed phases I and II on the new cervical device. In Phase I, we included 25 patients who underwent conization and placement of the device to assess its toxicity. In phase II, we compared two groups (with and without the use of an anti-stenosis device) to evaluate its efficacy and safety. Results: From August 2015 to June 2018, 265 participants were randomized (Phase I: 25, Phase II: 120 with DUDA ́s device and 120 without DUDA ́s device). The toxicity during phase I was observed in only one patient (4%) with pain grade > 7. There were 7 cases of toxicity during Phase II, 2 in the DUDA group (1.8%), and 5 in the No DUDA group (4.5%). The No DUDA group had a 2.5x higher complication rate than the DUDA group (p=0.52). When comparing the evolution at 3, 6, and 12 months in terms of cervical patency and visualization of the squamocolumnar junction (SCJ) during colposcopy, we did not find a significant difference. The DUDA group exhibited 15% to 19% nonvisualization of the SCJ, whereas that rate ranged from 10 to 12% in the No DUDA group. Conclusions: There was no statistically significant difference between the use or non- use of the antistenosis device to prevent cervical stenosis. This study opens up space for a discussion of cervical stenosis related to the type of conization performed and the use of antistenosis devices to help lower the stenosis rate.