Dataset Information

A randomized trial comparing limited-excision conisation to Large Loop Excision of the Transformation Zone (LLETZ) in cervical dysplasia patients.

ABSTRACT: OBJECTIVE:To show noninferiority of a limited-excision (resection of the dysplastic lesion only) vs. classical Large Loop Excision of the Transformation Zone (LLETZ). METHODS:In this prospective, randomized, multicenter trial, women with human papillomavirus (HPV) positive cervical intraepithelial neoplasia grade 3 were randomized into two groups (1:1). Primary outcome was the rate of negative HPV tests after 6 months, secondary outcomes included cone size, complete resection rates as well as cytological and histological results after 6 and 12 months. A sample size of 1,000 was calculated to show noninferiority of the limited-excision compared to the LLETZ group using a noninferiority margin of 5%. Enrollment was stopped after 100 patients due to slow accrual. RESULTS:Patients in the limited-excision group did not show a lower number of negative HPV tests (78% [LLETZ]-80% [limited-excision]=-2%; 90% confidence interval=-15%, 12%). The limited-excision resulted in a substantially lower cone size (LLETZ: 1.97 mL vs. limited-excision: 1.02 mL; p<0.001) but higher numbers of involved margins (LLETZ: 8% vs. limited-excision: 20%). Although postoperative cytological results slightly differed, histological results were similar in both groups. One limited-excision patient received immediate re-conisation, whereas one patient in each group was scheduled for re-conisation after 6 months. CONCLUSION:The limited-excision could represent a promising option to reduce the surgical extent of conisations while maintaining oncological safety. The trial was not sufficiently powered to reach statistical significance due to early termination. Nevertheless, the study provides important insights in the feasibility of a limited-excision and could serve as a pilot study for future trials. TRIAL REGISTRATION:German Clinical Trials Register Identifier: DRKS00006169.

SUBMITTER: Kolben TM

PROVIDER: S-EPMC6424847 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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A randomized trial comparing limited-excision conisation to Large Loop Excision of the Transformation Zone (LLETZ) in cervical dysplasia patients.

Kolben Theresa Maria TM Etzel Lea T LT Bergauer Florian F Hagemann Ingke I Hillemanns Peter P Repper Monika M Kaufmann Andreas M AM Sotlar Karl K Kolben Thomas T Helms Hans Joachim HJ Gallwas Julia J Mahner Sven S Dannecker Christian C

Journal of gynecologic oncology 20190501 3

<h4>Objective</h4>To show noninferiority of a limited-excision (resection of the dysplastic lesion only) vs. classical Large Loop Excision of the Transformation Zone (LLETZ).<h4>Methods</h4>In this prospective, randomized, multicenter trial, women with human papillomavirus (HPV) positive cervical intraepithelial neoplasia grade 3 were randomized into two groups (1:1). Primary outcome was the rate of negative HPV tests after 6 months, secondary outcomes included cone size, complete resection rate ...[more]

PMID: 30887760

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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:BackgroundThe 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.MethodRandomized 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.ResultsThere 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.ConclusionThis 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 morbidityTrial registrationNumber at ClinicalTrials.gov: NCT01929993 (June 10, 2012).

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.

Project description:BackgroundAs LEEP (loop electrosurgical excision procedure) is being increasingly used for the diagnosis and treatment of uterine cervical intraepithelial neoplasia, surgical smoke during LEEP has become an inevitable health issue. Therefore, in this study, exposure to the chemical substances in surgical smoke produced during LEEP was assessed.MethodsSmoke samples from patients with high-grade cervical intraepithelial neoplasia undergoing LEEP were collected by smoke-absorbing devices situated 1 m away from the operating table and near the nose of the operator during LEEP. Each plume sample was collected after 5 patients underwent LEEP, requiring 5 min for smoke collection for each patient. The chemicals of exposure to surgical smoke were assessed, and the hazard classes of these chemical components were evaluated by the International Agency for Research on Cancer.ResultsQualitative analysis of the smoke produced during LEEP revealed a variety of potentially toxic chemicals under standard detection, such as benzene, toluene, xylene, ethylbenzene, styrene, butyl acetate, acrylonitrile, 1,2-dichloroethane, phenol, chlorine, cyanide, hydrogen cyanide and carbon monoxide. Additionally, the average concentration of carbon dioxide was 0.098 ± 0.015% during surgery and was higher than that before surgery (0.072 ± 0.007%, P < 0.001), and the concentration of formaldehyde was significantly higher during surgery (0.023 ± 0.009 mg/m3, P < 0.05) than before surgery (0.012 ± 0.001 mg/m3, P < 0.05).ConclusionsMost of the detected chemical concentrations in smoke generated during LEEP were below the exposure limits when local exhaust ventilation procedures were efficiently used. However, the concentrations of carbon dioxide and formaldehyde found in smoke were significantly higher after surgery. Wearing a high-filtration mask and using evacuation devices routinely and consistently when performing LEEP are recommended to protect perioperative personnel.

Project description:BackgroundThe 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).ObjectiveOur 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).MethodsA 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.ResultsFrom 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.ConclusionsThe 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.

Project description:ImportanceThe World Health Organization recommends cryotherapy or loop electrosurgical excision procedure (LEEP) for histologically confirmed cervical intraepithelial neoplasia (CIN) grade 2 or higher regardless of HIV status. Cryotherapy is more feasible in resource-limited settings but may be less effective for women living with HIV.ObjectiveTo evaluate whether cryotherapy or LEEP is a more effective treatment for high-grade cervical lesions among women with HIV.Design, setting, and participantsSingle-center randomized trial conducted among women with HIV and CIN grade 2 or 3. From June 2011 to September 2016, women with HIV in Kenya underwent cervical screening with Papanicolaou testing and confirmatory biopsy. The final date on which a study procedure was administered was September 7, 2016.InterventionsWomen with HIV infection and CIN grade 2 or 3 were randomized 1:1 to receive cryotherapy (n = 200) or LEEP (n = 200) and were followed up every 6 months for 24 months with a Papanicolaou test and confirmatory biopsy.Main outcome and measuresThe primary outcome was disease recurrence, defined as CIN grade 2 or higher on cervical biopsy, during the 24-month follow-up period.ResultsAmong 400 women who were randomized (median age, 37.4 [interquartile range, 31.9-43.8] years), 339 (85%) completed the trial. Over 2 years, 60 women (30%) randomized to cryotherapy had recurrent CIN grade 2 or higher vs 37 (19%) in the LEEP group (relative risk, 1.71 [95% CI, 1.12-2.65]; risk difference, 7.9% [95% CI, 1.9%-14.0%]; P = .01). Adverse events occurred in 40 women (45 events, including change in pathology and death due to other causes) in the cryotherapy group and in 30 women (38 events, including change in pathology and unrelated gynecological complications) in the LEEP group.Conclusions and relevanceIn this single-center study of women with HIV infection and CIN grade 2 or 3, treatment with LEEP compared with cryotherapy resulted in a significantly lower rate of cervical neoplasia recurrence over 24 months. Cost-effectiveness analysis is necessary to determine whether the additional benefit of LEEP represents an efficient use of the additional resources that would be required.Trial registrationClinicalTrials.gov Identifier: NCT01298596.

Project description:ObjectiveThe objective of this systematic review was to conduct a more comprehensive literature search and meta-analysis of original studies to evaluate the efficacy and safety of the loop electrosurgical excision procedure (LEEP) versus cold-knife conization (CKC) in conservative surgical treatment of cervical adenocarcinoma in situ (ACIS) for women who have not completed childbearing.MethodsSystematic searches were conducted in the PUBMED, EMBASE, Cochrane, and China National Knowledge Infrastructure (CNKI) databases to identify all potential studies involving patients with ACIS treated with LEEP versus CKC published until December 2015.ResultsEighteen retrospective studies were included in this systematic review. All the 18 included studies reported the rate of positive margins, and the results of the individual studies varied. The positive margins were 44% (267/607) after LEEP and 29% (274/952) after CKC. The pooled meta-analysis exhibited significantly different outcome (RR, 1.55; 95% CI, 1.34-1.80, P<0.00001) without significant heterogeneity (P = 0.34). The residual rate following LEEP was 9.1% (17/186) and 11% (39/350) after CKC in re-cone or hysterectomy cases. Recurrent ACIS following LEEP was reported in 10 of 142 (7.0%) cases compared to 10 of 177 (5.6%) cases following CKC. There were no significant differences in the residual rate (RR, 1.02; 95% CI, 0.60-1.72, P = 0.95) or recurrence rate (RR, 1.13; 95% CI, 0.46-2.79; P = 0.79) between the two procedures.ConclusionsThe present systematic review demonstrates that both LEEP and CKC are safe and effective for the conservative treatment of ACIS. LEEP appears to be as equally effective as CKC regarding the residual and recurrence rates. Due to the findings showing that LEEP achieves comparable oncologic outcomes with fewer obstetric complications to that of CKC, LEEP may be the preferred option in patients whose fertility preservation is important. However, further prospective studies with a larger sample size and longer follow-up periods are needed to establish the superiority of either procedure.

Dataset Information

A randomized trial comparing limited-excision conisation to Large Loop Excision of the Transformation Zone (LLETZ) in cervical dysplasia patients.

Publications

A randomized trial comparing limited-excision conisation to Large Loop Excision of the Transformation Zone (LLETZ) in cervical dysplasia patients.

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