Objective
This study aimed at assessing the association of the relative risk (RR) of adverse pregnancy outcomes with previous treatment of loop electrosurgical excision procedure (LEEP) for the ...management of cervical intraepithelial neoplasia (CIN).
Methods
Data sources were from MEDLINE, EMBASE, and SCI citation tracking. Selection criteria: The eligible studies had data on pregnancy outcomes of women with or without previous treatment for CIN. Considered outcomes were severe preterm delivery (<34/32 weeks), extreme preterm delivery (<28 weeks), low birth weight (<2,500 g), stillbirth, preterm spontaneous rupture of membranes, perinatal mortality, and neonatal mortality and induction.
Results
36,954 cases and 1,794,174 controls in 4 prospective cohort and 22 retrospective studies were included in this meta-analysis. LEEP was associated with a higher risk of severe preterm delivery (<32 weeks, relative risk 1.98, 95 % CI 1.31, 2.98 159/11,337 vs. 7,830/860,883), extreme preterm delivery (<28 weeks, RR, 2.33, 95 % CI 1.84, 2.94 97/9,611 vs. 1,559/618,332), preterm premature rupture of the membranes (RR, 1.88, 95 % CI 1.54, 2.29 126/2,837 vs. 7,899/313,094), and low birth weight (<2,500 g, RR, 2.48, 95 % CI 1.75, 3.51 110/1,451 vs. 55/1,742). A cervical length of less than 3 cm was significantly increased in LEEP as compared with that of control group (RR, 4.88, 95 % CI 1.56, 15.25), but increasing LEEP volume or depth was not associated with an increased rate of preterm birth <37 weeks. And LEEP was not associated with a significantly increased risk of perinatal mortality, cesarean section, stillbirth mortality, neonatal mortality, induction, and neonatal intensive care unit admission.
Conclusions
LEEP is associated with an increased risk of subsequent preterm delivery (<32/34, <28 weeks) and other serious pregnancy outcomes. But increasing LEEP volume or depth is not associated with an increased rate of preterm birth.
The objective of this research is to evaluate cervical regeneration after large loop excision of the transformation zone (LLETZ) through the identification of a new sonographic reference point at the ...level of the uterine margins. In the period March 2021-January 2022, a total of 42 patients affected by CIN 2-3 were treated with LLETZ at the University Hospital of Bari (Italy). Before performing LLETZ, cervical length and volume were measured with trans-vaginal 3D ultrasound. From the multiplanar images, the cervical volume was obtained using the Virtual Organ Computer-aided AnaLysis (VOCAL™) program with manual contour mode. The line that connects the points where the common trunk of the uterine arteries reaches the uterus splitting into the ascending major branch and the cervical branch was considered as the upper limit of the cervical canal. From the acquired 3D volume, the length and the volume of the cervix were measured between this line and the external uterine os. Immediately after LLETZ, the removed cone was measured using Vernier's caliper, and before fixation in formalin, the volume of the excised tissue was evaluated by the fluid displacement technique based on the Archimedes principle. The proportion of excised cervical volume was 25.50 ± 17.43%. The volume and the height of the excised cone were 1.61 ± 0.82 mL and 9.65 ± 2.49 mm corresponding to 14.74 ± 11.91% and 36.26 ± 15.49% of baseline values, respectively. The volume and length of the residual cervix were also assessed using 3D ultrasound up to the sixth month after excision. At 6 weeks, about 50% of cases reported an unchanged or lower cervical volume compared to the baseline pre-LLETZ values. The average percentage of volume regeneration in examined patients was equal to 9.77 ± 55.33%. In the same period, the cervical length regeneration rate was 69.41 ± 14.8%. Three months after LLETZ, a volume regeneration rate of 41.36 ± 28.31% was found. For the length, an average regeneration rate of 82.48 ± 15.25% was calculated. Finally, at 6 months, the percentage of regeneration of the excised volume was 90.99 ± 34.91%. The regrowth percentage of the cervical length was 91.07 ± 8.03%. The cervix measurement technique that we have proposed has the advantage of identifying an unequivocal reference point in 3D cervical measurement. Ultrasound 3D evaluation could be useful in the clinical practice to evaluate the cervical tissue deficit and express the "potential of cervical regeneration" as well as provide the surgeon useful information about the cervical length.
Objective Few studies have investigated physical after‐effects of colposcopy. We compared post‐colposcopy self‐reported pain, bleeding, discharge and menstrual changes in women who underwent: ...colposcopic examination only; cervical punch biopsies; and large loop excision of the transformation zone (LLETZ).
Design Observational study nested within a randomised controlled trial.
Setting Grampian, Tayside and Nottingham.
Population Nine hundred‐and‐twenty‐nine women, aged 20–59, with low‐grade cytology, who had completed their initial colposcopic management.
Methods Women completed questionnaires on after‐effects at approximately 6‐weeks, and on menstruation at 4‐months, post‐colposcopy.
Main outcome measures Frequency of pain, bleeding, discharge; changes to first menstrual period post‐colposcopy.
Results Seven hundred‐and‐fifty‐one women (80%) completed the 6‐week questionnaire. Of women who had only a colposcopic examination, 14–18% reported pain, bleeding or discharge. Around half of women who had biopsies only and two‐thirds treated by LLETZ reported pain or discharge (biopsies: 53% pain, 46% discharge; LLETZ: 67% pain, 63% discharge). The frequency of bleeding was similar in the biopsy (79%) and LLETZ groups (87%). Women treated by LLETZ reported bleeding and discharge of significantly longer duration than other women. The duration of pain was similar across management groups. Forty‐three percent of women managed by biopsies and 71% managed by LLETZ reported some change to their first period post‐colposcopy, as did 29% who only had a colposcopic examination.
Conclusions Cervical punch biopsies and, especially, LLETZ carry a substantial risk of after‐effects. After‐effects are also reported by women managed solely by colposcopic examination. Ensuring that women are fully informed about after‐effects may help to alleviate anxiety and provide reassurance, thereby minimising the harms of screening.
Purpose
We address the impact of applying loop electrosurgical excision procedure (LEEP) under direct colposcopic vision teaching to our undergraduates using a self-developed simulation model and a ...standardized assessment to evaluate the progress of learning.
Methods
The undergraduate teaching module was composed of a theoretical course on cervical dysplasia, colposcopy, electrosurgery and excisional procedures of the uterine cervix. This was followed by hands-on practical rounds. During the hands-on practice the students performed five “type 1” LEEP under direct colposcopic vision on the self-developed simulator. Based on specimen fragmentation and excision accuracy a score system was established. The students were asked to answer a course evaluation questionnaire.
Results
The accuracy of the excisions showed a statistically significant improvement during the five training procedures (excision depth 7.34 ± 1.60–8.54 ± 1.67 mm,
p
= 0.0041; deviation from target cone thickness 0.88 ± 1.16–0.13 ± 0.94 mm,
p
= 0.0116). The fragmentation of the conus decreased (2.57 ± 1.26–1.29 ± 0.60 pieces,
p
< 0.0001). All this led to a general improvement of the LEEP score (2.59 ± 1.93–0.84 ± 1.03,
p
= 0.001). The student’s questionnaire revealed a subjective satisfaction and improvement of their knowledge in pathomechanism, diagnosis and therapy of cervical pathologies.
Conclusion
Undergraduate surgical training, in cervical excisional procedure, is a successful method in improving the students’ perception and management of cervical pathologies.
Presently, for those diagnosed with early cervical cancer who wish to conserve their fertility, there is the option of radical trachelectomy. Although successful, this procedure is associated with ...significant obstetric morbidity. The recurrence risk of early cervical cancer is low and in tumors measuring less than 2 cm; if the lymphatics are negative, the likelihood of parametrial involvement is less than 1%. Therefore, pelvic lymph nodes are a surrogate marker of parametrial involvement and radical excision of the parametrium can be omitted if they are negative.
The aim of this study was to report our experience of the fertility conserving management of early cervical cancer with repeat large loop excision of the transformation zone and laparoscopic pelvic lymph node dissection.
Between 2004 and 2011, a retrospective review of cases of early cervical cancer who had fertility conserving management within Glasgow Royal Infirmary was done.
Forty-three patients underwent fertility conserving management of early cervical cancer. Forty were screen-detected cancers; 2 were stage IA1, 4 were stage IA2, and 37 were stage IB1. There were 2 central recurrences during the follow-up period. There have been 15 live children to 12 women and there are 4 ongoing pregnancies.
To our knowledge, this is the largest case series described and confirms the low morbidity and mortality of this procedure. However, even within our highly select group, there have been 2 cases of central recurrent disease. We, therefore, are urging caution in the global adoption of this technique and would welcome a multicenter multinational randomized controlled trial.
Purpose
To compare the cure rates between women who were treated with cold-coagulation versus large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia grade 2 ...(CIN2) or 3 (CIN3) on pretreatment cervical punch biopsies.
Methods
This was a retrospective cohort study of women having had a single cervical treatment for CIN2 or CIN3 on pretreatment cervical punch biopsies between 2010 and 2011. The cure rates were defined as the absence of any dyskaryosis (mild/moderate/severe) on cytology tests during follow-up and were determined at 6 and 12 months after treatment.
Results
We identified 411 women having had cervical treatment with 178 cases of cold-coagulation and 233 cases of LLETZ. The cure rates at 6 months following cold-coagulation and LLETZ treatment were 91.6 versus 97.1% (
p
= 0.02), whereas at 12 months, they were 96.5 versus 97.3% (
p
= 0.76). Multivariable analysis showed that after adjusting for confounding factors, there was a fourfold higher cure rate with LLETZ in comparison with cold-coagulation at 6 months after treatment (adjusted OR 4.50, 95% CI 1.20–16.83;
p
= 0.026), with this difference disappearing at 12 months. The lower cure rates with cold-coagulation were due to its higher rates of mild dyskaryosis cytology tests at 6 months. The rates of moderate/severe dyskaryosis cytology tests were similar between the two treatment methods at 6 and 12 months.
Conclusion
We found that women with CIN2 or CIN3 on pretreatment cervical punch biopsies, after adjusting for multiple confounding factors, had higher cure rates when treated with LLETZ versus cold-coagulation at 6 months, with this difference disappearing at 12 months.
Cervical dysplasia (cervical intraepithelial neoplasia (CIN)) is caused by Human Papillomavirus (HPV) and is most common in women of reproductive age. Current treatment of moderate to severe CIN is ...surgical. This procedure has potential complications, such as haemorrhage, infection and preterm birth in subsequent pregnancies. Moreover, 15% of women treated for high grade CIN develop residual/recurrent CIN or cervical cancer after surgical excision. Finally, 75-100% of patients with a residual and recurrent CIN 2-3 lesion are still HPV positive. They could possibly benefit from an alternative medical treatment, which aims to eliminate HPV. The primary study objective is to evaluate the effectivity of imiquimod 5% cream compared to treatment with Large Loop Excision of the Transformation Zone (LLETZ) for recurrent/residual CIN.
This study is a multicentre, non-inferiority randomized single blinded study. The study population consists of female patients with histological proven residual/recurrent CIN after previous surgical treatment. Four hundred thirty-three patients will be included in the Netherlands. The first 35 patients will be included in a pilot study to prove non-futility. Included patients will be randomized to receive either 5% imiquimod cream or LLETZ treatment. Imiquimod will be inserted three times a week intravaginally for a period of 16 weeks using a vaginal applicator. Ten weeks after the end of imiquimod treatment a biopsy will be taken for treatment response. In case of progressive or stable disease a LLETZ will be performed. At 12 and 24 months after the start of treatment cytology will be taken for follow up. The LLETZ group will be treated according to the current guidelines. Throughout the study, HPV typing and quality of life will be tested.
Repeated LLETZ in women with residual/recurrent CIN lesions has complications. We would like to possibly offer alternative treatment in a selected group to avoid these risks. Moreover, we monitor treatment efficacy, side effects and long-term recurrence rates.
Medical Ethical Committee approval number: NL 53792.078.15. Affiliation: Erasmus Medical Center. Registration number ClinicalTrials.gov : NCT02669459 , date of registration: 27th January 2016.
Purpose
To compare the pregnancy outcomes between women who were treated with cold-coagulation versus large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia.
...Methods
This was a retrospective cohort study of women who had a single cervical treatment between 2010 and 2011. We identified those women who had a singleton pregnancy subsequent to their cervical treatment until September 2017. Women with previous cervical treatment, previous miscarriage or preterm delivery were excluded.
Results
We identified 86 women with a pregnancy after LLETZ treatment and 75 women after cold coagulation. Those who had LLETZ when compared to cold coagulation miscarried more often in the first trimester (33.7 vs 17.3%;
p
= 0.01) than in the second trimester. In women with LLETZ this effect of increased early miscarriage was shown to be prolonged and to persist up to 17 months after excision. Women with LLETZ when compared to cold coagulation had higher spontaneous preterm birth rates (8.9 vs 6.7%) even though the difference was non significant, with the earliest spontaneous preterm birth occurring at 32 weeks and 34 weeks, respectively.
Conclusion
We found that women who received LLETZ treatment when compared to cold coagulation had higher spontaneous preterm birth rates in their subsequent pregnancy and miscarried more frequently in the first trimester, and demonstrated an increased early miscarriage risk that persisted for more than a year after excisional treatment.
Background
Electrosurgical 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.
Methods
A 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).
Results
Nine 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.
Conclusion
The 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.