A randomized clinical trial of a new anti-cervical stenosis device after conization by loop electrosurgical excision.

Marcelo De Andrade Vieira,Ronaldo Luis Schmidt,Agnaldo Lopes Filho,Ricardo Dos Reis,Carlos Eduardo Mattos Da Cunha Andrade,Raphael Leonardo Cunha De Araújo,Emily Chenette

doi:10.1371/journal.pone.0242067

Abstract

The complications inherent to conization include vaginal bleeding, cervical stenosis, amenorrhea, dysmenorrhea, and deep dyspareunia. Cervical stenosis is the most important complication due to the clinical repercussions. Studies show rates of cervical stenosis ranging from 1.3 to 19% after the Loop Electrosurgical Excision Procedure (LEEP). 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). A randomized clinical trial was performed including phases II and III for evaluation of a new device for cervical stenosis prevention. In Phase II, we included 25 patients who underwent LEEP and placement of the device to assess its toxicity and efficacy. In phase III, we compared two groups (with and without the use of an anti-stenosis device) to evaluate its efficacy and safety. From August 2015 to June 2018, 265 participants were randomized (Phase II: 25, Phase III: 120 with DUDA and 120 without DUDA). The toxicity during phase II was observed in only one patient (4%) with pain grade > 7. There were 7 cases of toxicity during Phase III, 2 in the DUDA group (1.8%), and 5 in the No DUDA group (4.5%). The complications rate was numerically higher in the No DUDA group (2.5x higher) than the DUDA group, but this difference did not reach statistical significance (p = 0.52). The rate of cervical stenosis in DUDA group was (4-7,3%), and in No DUDA group was (4.3-5.8%) (p = 0.5). We did not find a significant difference when comparing the evolution at 3, 6, and 12 months in terms of cervical patency and visualization of the squamocolumnar junction (SCJ) during colposcopy. The DUDA group exhibited 15% to 19% nonvisualization of the SCJ, whereas that rate ranged from 10 to 12% in the No DUDA group. The rate of cervical stenosis was not different comparing the use of a new device, specifically produced to prevent cervical stenosis, compared to no use after LEEP procedure. This clinical trial opens up space for a discussion of the utility of using cervical stenosis devices after LEEP. Perhaps in another type of conization it can be evaluated to avoid cervical stenosis.

Highlights

Infection with the human papillomavirus (HPV) virus is common among women
The rate of cervical stenosis was not different comparing the use of a new device, produced to prevent cervical stenosis, compared to no use after Loop Electrosurgical Excision Procedure (LEEP) procedure
This clinical trial opens up space for a discussion of the utility of using cervical stenosis devices after LEEP

Summary

Introduction

Infection with the human papillomavirus (HPV) virus is common among women. In most cases, after 6 to 12 months of infection, the immune system eliminates the virus. Women may develop cancer precursor lesions in the cervix and, if not treated, cervical cancer [1,2,3,4]. The natural history of CIN II indicates that 32% to 43% of untreated lesions will regress without treatment, while 35% to 56% will persist and 14% to 22% will progress to carcinoma in situ or invasive carcinoma [5,6,7]. When assessing CIN III lesions, studies show that within 30 years after infection, 31% of patients will develop cervical cancer [2]. When we group the premalignant lesions into CIN II and III, studies show that in 10 to 20 years, the progression to cancer will occur in some cases if they are left. Studies show rates of cervical stenosis ranging from 1.3 to 19% after the Loop Electrosurgical Excision Procedure (LEEP)

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