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

Abstract

Background 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). Objective 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). Methods 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. Results 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. Conclusions 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.

Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

“…Using the remaining 37 citations, cross reference searching identified two further appropriate citations. Thus, in summary, 39 citations reporting on diagnostic and therapeutic interventions in women with cervical dysplasia within a controlled trial setting were included in this review [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , …”

“…The clinical characteristics of individual studies reporting on therapeutic procedures in women with cervical dysplasia are shown in Table 2 . We identified 20 RCTs with 3355 participants [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ] and one PCT with 297 participants [ 17 ]. in total, 4 RCTs found that alternative electrosurgical techniques such as Straight Wire Excision of the Transformation Zone (SWETZ), Contour-Loop Excision of the Transformation Zone (C-LETZ), and True Cone Biopsy Electrode Excision (TCBEE) were comparable to the standard LEEP/LLETZ procedure with minimal differences regarding specimen fragmentation and endocervical resection margin status [ 26 , 27 , 28 , 31 ].…”

“…Figure 2 shows the methodological quality of all 21 RCTs. In 6/21 trials, there was a significant risk of bias [ 24 , 25 , 28 , 36 , 43 , 45 ], limiting the validity of the results. Figure 3 shows the overall and specific bias risks given as a percentage of all RCTs.…”

“…Therefore, evidence-based diagnostic and therapeutic interventions for LSIL/HSIL are an important worldwide medical need. In order to clarify what progress has been made in this field during the last decade, we systematically searched the literature between 2012 and 2021 and identified 39 high-quality controlled trials, RCTs, and PCTs, reporting on diagnostic and therapeutic interventions in women with cervical dysplasia [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , ...…”

“…Of note, in a third of all trials, significant methodological limitations regarding patient selection, randomization process, and interpretation were identified. Thus, further confirmatory trials are necessary to assess if the effects shown in these studies [ 13 , 17 , 24 , 25 , 28 , 36 , 43 , 45 ] are real. Another important issue in studies investigating colposcopy and colposcopically-guided cervical biopsies is the experience of the colposcopists included in these studies.…”