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A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study.

ABSTRACT: The management of preinvasive cervical lesions has the objective to ensure the absence of invasive lesions and to prevent progression to cancer. Excisional procedures have been preferred to treat these lesions as they report the presence of unsuspected invasive lesions and the status of surgical margins, allowing inferring full excision when such are free of disease. The purpose of this study is to determine whether Straight Wire Excision of the Transformation Zone (SWETZ) is a better alternative than Large Loop Excision of the Transformation Zone (LLETZ-cone) as a type 3 excision of the Transformation Zone (TZ) to reduce incomplete excision and concerning other outcomes of surgical interest.Randomized controlled trial including women who needed type 3 excision of the TZ referred to a colposcopy clinic after cytological screening between January 2008 thru December 2011. The interventions were performed using local anesthesia and sedation in an inpatient basis by different experienced surgeons. The study enrolled and randomized 164 women, of which 82 were allocated to each group. After exclusions, 78 remained in SWETZ and 76 in LLETZ-cone groups for the analysis of outcomes of surgical interest and 52 and 54, respectively, for the margins analysis.There was an even distribution between the groups after randomization and exclusions, concerning mean age, parity, current smoking, prior cytological diagnosis and histopathological diagnosis obtained in cone specimen even after exclusions. We observed significantly higher risk of compromised or damaged endocervical margin in specimens resulting from the LLETZ-cone in relation to SWETZ (RR 1.72, 95% CI: 1.14 to 2.6), with an absolute risk reduction (ARR) of 26.4% (95% CI: 8.1 to 44.8) for patients operated by SWETZ. The specimens obtained by SWETZ showed less fragmentation (ARR?=?19.8%, 95% CI: 10.3 - 29.3%), but the procedure took longer. There were complications in 5.6% of the procedures, with no significant differences between the groups.This study showed a lower proportion of compromised or damaged endocervical surgical margin in specimens resulting from SWETZ in relation to LLETZ-cone. SWETZ demonstrated to be more efficient than LLETZ-cone concerning less fragmentation of the specimen obtained. However, it accounted for longer surgical time. Both techniques showed morbidityNumber at ClinicalTrials.gov: NCT01929993 (June 10, 2012).

SUBMITTER: Russomano F

PROVIDER: S-EPMC4336713 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study.

Russomano Fábio F Tristao Maria Aparecida Pereira MA Côrtes Renata R de Camargo Maria José MJ

BMC women's health 20150218

<h4>Background</h4>The management of preinvasive cervical lesions has the objective to ensure the absence of invasive lesions and to prevent progression to cancer. Excisional procedures have been preferred to treat these lesions as they report the presence of unsuspected invasive lesions and the status of surgical margins, allowing inferring full excision when such are free of disease. The purpose of this study is to determine whether Straight Wire Excision of the Transformation Zone (SWETZ) is ...[more]

PMID: 25783647

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Project description:BackgroundElectrosurgical excisions are common procedures for treating cervical dysplasia and are often seen as minor surgeries. Yet, thorough training of this intervention is required, as there are considerable consequences of inadequate resections, e.g. preterm birth, the risk of recurrence, injuries and many more. Unfortunately, there is a lack of sufficiently validated possibilities of simulating electrosurgeries, which focus on high fidelity and patient safety.MethodsA novel 3D printed simulator for examination and electrosurgical treatment of dysplastic areas of the cervix was compared with a conventional simulator. Sixty medical students experienced a seminar about cervical dysplasia. Group A underwent the seminar with the conventional and Group B with the novel simulator. After a theoretical introduction, the students were randomly assigned by picking a ticket from a box and went on to perform the hands-on training with their respective simulator. Each student first obtained colposcopic examination training. Then he or she performed five electrosurgical excisions (each). This was assessed with a validated score, to visualize their learning curve. Furthermore, adequate and inadequate resections and contacts between electrosurgical loop and vagina or speculum were counted. Both groups also assessed the seminar and their simulator with 18 questions (Likert-scales, 1-10, 1 = strongly agree / very good, 10 = strongly disagree / very bad). Group B additionally assessed the novel simulator with four questions (similar Likert-scales, 1-10).ResultsNine of 18 questions showed statistically significant differences favoring Group B (p < 0.05). Group B also achieved more adequate R0-resections and less contacts between electrosurgical loop and vagina or speculum. The learning curves of the performed resections favored the novel simulator of Group B without statistically significant differences. The four questions focusing on certain aspects of the novel simulator indicate high appreciation of the students with a mean score of 1.6 points.ConclusionThe presented novel simulator shows several advantages compared to the existing model. Thus, novice gynecologists can be supported with a higher quality of simulation to improve their training and thereby patient safety.

Project description:Large loop excision of the transformation zone (LLETZ) is one of the most common procedures in operative gynecology and it is a routine part of the surgical training program of residents. There is, however, no established and standardized method of teaching residents how to perform LLETZ. Here, we present a surgical training model and assessed the improvement of surgical skills during repeated hands-on trainings of LLETZ in this model.Surgical novices and experts were recruited and were shown a LLETZ training video and then performed 3 LLETZ training sessions on consecutive days. Surgical skills were assessed by Objective Structured Assessment of Technical Skills (OSATS). Global rating scale (GRS), confidence (CON), fragmentation rate (FR), performance time (PT), and OSATS scores were calculated. Intra- and interobserver variabilities were determined. The construct validity of OSATS was assessed comparing metric scores of novices with those of experts.Sixty-eight probands (58 novices, 10 experts) were recruited. GRS, 2.3 ± 1.3 (median ± SD) versus 1.4 ± 0.6, P < .001; CON, 2.7 ± 0.9 versus 1.6 ± 0.6, P < .001; FR, 81% versus 100%, P < .001; PT, 152 ± 33 versus 120 ± 27 seconds, P = .006; and OSATS scores, 18.8 ± 1.3 versus 19.1 ± 1.1, P = .16 of novices improved from session 1 to session 3. OSATS showed construct validity with metric scores (GRS, 1.1 ± 0.3 vs 2.3 ± 0.8, P < .001; CON, 1.0 ± 0.0 vs 2.7 ± 0.9, P < .001; PT 125 ± 30 vs 152 ± 33 seconds, P = .02; OSATS scores, 19.6 ± 0.7 vs. 18.8 ± 1.3, P = .02) reliably discriminating between experts and novices. Intra- and interobserver variabilities across probands were 0.99 ± 0.03 and 0.64 ± 0.10, respectively. OSATS scores were independent of handedness, sex, and regular sports activity in univariate and multivariate analyses.Repeated hands-on trainings improve surgical performance of LLETZ in a surgical training model with construct validity.

Dataset Information

A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study.

Publications

A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study.

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