A randomized trial of the Fischer cone biopsy excisor and loop electrosurgical excision procedure

OBJECTIVE: To compare specimens obtained with the Fischer cone biopsy excisor or loop electrosurgical excision procedure (LEEP) with respect to number of specimens obtained, margin interpretability, adequacy of excision, and ease of use. METHODS: One hundred eligible patients aged 13 years and older were randomly assigned to treatment with the Fischer cone biopsy excisor or LEEP. Eligibility criteria included: (1) cervical intraepithelial neoplasia (CIN) 2 or 3, (2) persistent CIN 1, or (3) cytologic/histologic discrepancy. Following excision, providers ranked ease of use on a scale of 1 to 10. A pathologist blinded to procedure type analyzed specimens for margin interpretability and adequacy of excision. Before study initiation we calculated that a total of 100 patients would be required to demonstrate a significant difference in the interpretable margin rate of 80% for LEEP and 99% for cone biopsy excisor (power 80%, alpha =.05). RESULTS: After adjustment for ease of use, lesion size, and degree of neoplasia, the cone biopsy excisor was no more likely to result in a single specimen than LEEP (74% versus 63%, relative risk [RR] 0.93, 95% confidence interval [CI] 0.79 -1.11), to result in a specimen with interpretable margins (65% versus 73%, RR 0.97, 95% CI 0.78-1.22), or to result in a fully excised cervical lesion (72% versus 62% for LEEPs, RR 1.08, 95% CI 0.77-1.52). Providers found their experiences with both Fischer cone biopsy excisor and LEEP cone biopsies to be similar, even after adjustment for year of training and previous experience (RR 0.95, 95% CI 0.72-1.24). CONCLUSION: The Fischer cone biopsy excisor and LEEP performed similarly with respect to the number of final specimens, margin interpretability, and ease of use. LEVEL OF EVIDENCE: I     

Persistent and recurrent cervical dysplasia after loop electrosurgical excision procedure

OBJECTIVE: Our objective was to determine whether demographic, colposcopic, and pathologic variables are predictive of recurrent cervical dysplasia. STUDY DESIGN: A retrospective review of patients who underwent loop electrosurgical excision procedure (LEEP) was performed. The medical records of the subjects were reviewed to identify demographic, pathologic, and procedural characteristics that predict recurrent dysplasia. RESULTS: A total of 514 subjects were identified who underwent LEEP between 1996 and 2003. Multivariate analysis revealed that advanced age, immunosuppression, and a positive endocervical margin were associated with recurrent dysplasia. CONCLUSION: Demographic and pathologic data can be used to predict the risk of recurrence of cervical dysplasia after LEEP.     

Thermal artefact after diathermy loop excision and laser excision cone biopsy

Dalrymple C, Russell P. Thermal artefact after diathermy loop excision and laser excision cone biopsy. Int J Gynecol Cancer 1999; 9 : 238–242.
Whether or not thermal artefact precludes accurate histopathologic assessment of excision biopsies of the uterine cervix is currently controversial. Some authors state that margins cannot be assessed at all while others feel that the pathologist can 'see through' the artefact in the majority of cases. Over a 7-month period, 164 patients had loop excision and 84 patients had laser cone biopsy. The zone of coagulation at the specimen periphery was measured and the adequacy of excision assessed. The average width for this zone of coagulation in diathermy loop was 0.32 mm and for laser cone biopsies was 0.31 mm. In 12% of the loop specimens the line of excision was compromised by dysplasia or its assessment was rendered uncertain by thermal artefact. This was far more common in fragmented specimens (20%) compared to those removed as a single specimen (6%). In this study, 40% of patients had fragmented loop specimens. Thus, in attempting to replace cone biopsy with loop excision, we are asking pathologists to reassemble a pathologic jigsaw, then look through the thermal artefact for a decision on margins. We believe that this fragmentation should preclude the use of loop excision for lesions which would previously have been managed by cone biopsy.     

云南白药预防宫颈环形电切术后的出血

目的:观察云南白药对宫颈环形电切术后创面出血的预防效果。方法:将105例接受宫颈环形电切术的慢性宫颈炎患者随机分为治疗组(n=55),预防组术后口服云南白药胶囊并喷涂云南白药喷雾剂于宫颈创面,对照组(n=52)常规治疗。结果:宫颈环形电切术治疗慢性宫颈炎治愈率为88.8%,总有效率为93.5%。使用云南白药后阴道出血持续时间少于对照组(8.4±4.5dvs11.2±6.5d,P<0.05)。脱痂期活动性出血发生率低于对照组(5.45%vs11.54,P<0.05)。结论:云南白药能减少宫颈环形电切术后阴道出血,对脱痂期活动性出血有一定预防作用。     

Risk factors for early cytologic abnormalities after loop electrosurgical excision procedure

OBJECTIVE: To evaluate risk factors for early cytologic abnormalities and recurrent cervical dysplasia after loop electrosurgical excision procedure (LEEP). METHODS: A retrospective analysis was performed of all pathology records for LEEPs performed at our institution from January 1996 through July 1998. Follow-up cytology from 2 through 12 months after LEEP was reviewed. Patients with abnormal cytology were referred for further colposcopic evaluation. Statistical analysis using chi2 test for trend, proportional hazards model test, Fisher exact tests, and life table analysis were performed to identify risk factors for early cytologic abnormalities after LEEP and to determine relative risk of recurrent dysplasia. RESULTS: A total of 298 women underwent LEEP during the study period, and 29% of these had cytologic abnormalities after LEEP. Grade of dysplasia, ectocervical marginal status, endocervical marginal status, and glandular involvement with dysplasia were not found to be independent risk factors for early cytologic abnormalities. However, when risk factors were analyzed cumulatively, the abnormal cytology rate increased from 24% with no risk factors to 67% with three risk factors present (P =.037). Of patients with abnormal cytology after LEEP, 40% developed subsequent dysplasia, and the mean time to diagnosis was approximately 6 months. The relative risk of subsequent dysplasia ranged from a 20% increase to twice the risk if post-LEEP cytology was low-grade squamous intraepithelial lesion or high-grade squamous intraepithelial lesion, respectively. CONCLUSION: Based on these results, consideration should be given for early colposcopic examination of patients who have evidence of marginal involvement or endocervical glandular involvement with dysplasia. These patients are at increased risk for abnormal cytology and recurrent dysplasia. This initial visit should occur at 6 months, as the mean time to recurrence of dysplasia was 6.5 months.     

Outcome after loop electrosurgical excision procedure for cervical high-grade squamous intraepithelial lesion

ObjectiveThe dilemma in treating cervical high-grade squamous intraepithelial lesion (HSIL) is how to achieve complete excision to minimize the risk of cervical cancer while sparing the anatomy of the cervix and its ability to function during pregnancy. The optimal management for positive margins after excisional treatment is still controversial. This study was conducted to determine the clinical and histologic predictors of residual/recurrent HSIL and assess the outcome of women with positive margin.Materials and methodsThis retrospective cohort study included 386 women who had excisional treatment for HSIL during 1st January 2012 to 31st December 2015 in a university-affiliated hospital.ResultsOverall, 212 (54.9%) women had negative margins and 155 (40.2%) had positive margins. The cumulative rate of residual/recurrent HSIL at 2 and 5 years was 15.7% and 16.8% respectively in positive margins and 1.8% and 5.0% respectively in negative margins (p < 0.001). Of women who had residual/recurrent HSIL, significantly more women had positive margins compared to negative margins (74.1% vs 25.9%, p = 0.001). Positive margin was significantly associated with higher rate of subsequent abnormal cervical smear (48.2% vs 28.9%, p < 0.001), requiring further colposcopy (32.1% vs 14.4%, p < 0.001) and further treatment for SIL (7.5% vs 4.8%, p < 0.001) compared to negative margin.ConclusionMost women (85%) with positive margin went without residual/recurrent HSIL, of which the option of close surveillance with cytology is reasonable. Repeat excision may be considered in selected women with positive margin, endocervical glandular involvement and those who are older or unable to comply with follow-up.     

Comparison of office loop electrosurgical conization and cold knife conization

A group of 98 patients with abnormal Papanicolaou smears underwent cold knife conization or loop electrosurgical conization after colposcopic examination and biopsy. Average duration of surgery, intraoperative bleeding, rate of complications, and cost of the procedure were significantly less for the electrosurgical conization group. We conclude that this procedure may be performed in the office in place of hospital cold knife conization for the diagnosis and treatment of cervical intraepithelial neoplasia.     

A simple trainer for the loop electrosurgical excision procedure

This article describes the construction and use of a simple trainer for the loop electrosurgical excision procedure (LEEP), also known as large loop excision of the cervical transformation zone (LLETZ).     

Pregnancy outcome after electrosurgical cervical cone biopsy using Fischer cone biopsy excisor

Objective: To evaluate the pregnancy outcomes of all patients who underwent electrosurgical cone biopsy of the cervix between January 2000 and December 2011 and subsequently became pregnant.

Study design: Retrospective cohort study.

Settings: District General Hospital in the North East of England.

Methods: Patients were identified from the local colposcopy electronic data, Hospital Episode Statistics and Maternity electronic data. Data were collected on a pro forma with two sections: (1) treatment section and (2) pregnancy section. In the treatment section, year and indication for treatment, volume of cervix removed, histological results and marginal status of specimen were documented. In the pregnancy section, time interval between treatment and pregnancy, pre-treatment obstetric history, cervical length measurements, cervical suture, gestation and mode of delivery and neonatal outcome were documented. Data were analysed using SPSS.

Results: 25 women achieved 47 pregnancies after electrosurgical cone biopsy treatment. Most common indication for cone biopsy was glandular neoplasia accounting for nearly half of the procedures; 21.2% of pregnancies ended in first-trimester miscarriages. The preterm delivery rate (<37 weeks) was 19.4%. Volume of cervix excised was significantly greater in women who delivered preterm compared to women who delivered at term (p?=?0.028). The rate of preterm delivery was significantly higher in post treatment pregnancies when compared to pregnancies before treatment in the same women (p?=?0.02). The preterm delivery in post-treatment pregnancies was not related to the time interval between treatment and pregnancy (p?=?0.54). There was no significant difference in miscarriage rates in pre- and post-treatment pregnancies (p?=?0.98).

Conclusion: Electrosurgical cone biopsy of cervix is associated with increased risk of preterm labour that is related to the volume of cervix excised.     

子宫颈上皮内瘤变患者行宫颈环切术对妊娠结局的影响

目的探讨对宫颈上皮内瘤变患者行宫颈环切术对妊娠结局的影响。方法回顾性分析1995年5月～2002年4月因宫颈上皮内瘤变行宫颈环切术27例患者的妊娠结局。结果占同期宫颈环切术手术的13．3％(27／203),患者年龄为23～40岁,中位年龄为30．3岁。27例中,10例因计划生育行人工流产术,1例异位妊娠,2例妊娠6～8周自然流产。14例足月分娩,其中阴道分娩9例。剖宫产5例。所有分娩孕妇的分娩孕周均大于38周,胎儿体重2905～4000g。新生儿1分钟Apgar评分：9分2例;10分12例,无新生儿窒息。结论宫颈环切术是治疗子宫颈上皮内瘤变的安全有效方法,只要掌握手术指征和手术切除范围,对其后的妊娠生育是安全的。     

Evaluation of the cone biopsy excisor compared with the large loop for electrosurgical excision of cervical lesions

Data incorporated from August 1994 to July 30, 1997.Objective: To compare a newly designed triangular electrode, the Cone Biopsy Excisor™ to the loop electrode with respect to the margin evaluation, fragmentation, and thermal damage of the conization specimen.Methods: After approval by the Institutional Review Boards of Hartford Hospital, St. Francis Hospital, and New Britain General Hospital/University of Connecticut, patients were randomly assigned to undergo conization with the Cone Biopsy Excisor or with the large loop. Inclusion criteria included biopsy proven CIN II, CIN III, inadequate colposcopy, positive endocervical curettage, or cytohistological discrepancy. Exclusion criteria included pregnancy, undiagnosed uterine bleeding, and invasive carcinoma. The procedures were performed by senior residents on clinic patients at the respective institutions. In addition, after FDA approval November 18, 1996, private OB/GYN practitioners performed cases and added those results to the study. Seventy-eight patients were randomized to the Cone Biopsy Excisor, while 77 patients were randomized to the loop electrosurgical excision procedure (LEEP). To obtain the surgical specimen, Force 2 Valley Lab generators were used with wattage ranging from 35 to 50 according to the size of the instrument chosen, 40/60 blend of coagulation, and cutting current.Pathology reports were reviewed to determine the amount of fragmentation that occurred during the procedure and for tissue diagnosis. Specimens were then evaluated by two gynecologic pathologists blinded to the instrument used. The specimens were analyzed for the ability to evaluate the margins and for degree of thermal damage. A thermal damage score was assigned to each specimen. The scoring system results in 4 levels of thermal damage, from one (minimal thermal damage) to four (heavy thermal damage). Follow-up data was obtained from the patients’ medical and pathology records.Results: Seventy-two of 78 (92%) Cone Biopsy Excisor cases vs 10 of 77 (13%) LEEP cases submitted one specimen to pathology, P < .001 based on a χ² test. Mean number of specimens submitted to pathology per case in the Cone Biopsy Excisor group was 1.1 ± 0.5 vs 2.2 ± 0.8 in the LEEP group, P < .001 based on a t test. Margins were unable to be interpreted because of thermal damage in 2 of 78 (3%) in the Cone Biopsy Excisor group vs 14 of 77 (18%) in the LEEP group, P < .003 based on a χ² test.Conclusion: The Cone Biopsy Excisor provided a cervical specimen that had less fragmentation and less thermal damage with margins that were less likely to be indeterminate than those obtained with the large loop electrosurgical procedure.

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A comparison between loop electrosurgical excision procedure and cold knife conization for treatment of cervical dysplasia: residual disease in a subsequent hysterectomy specimen

OBJECTIVE: The purpose of this study was to determine whether the loop electrosurgical excision procedure (LEEP) is as effective as cold knife conization (CKC) in the removal of cervical dysplasia. METHODS: One-hundred sixteen patients with cervical intraepithelial neoplasia were included: 73 cases treated with LEEP and 43 cases treated with CKC. All of these patients underwent subsequent hysterectomy within 6 months of treatment. A thorough histological evaluation of the cone specimens and post-cone hysterectomy specimens was performed. RESULTS: No residual disease in the post-cone hysterectomy specimens was identified in 63% of the LEEP group and 72.1% of the CKC group. There was no significant difference in the proportion of negative residual disease (P > 0.05). The mean diameters of the base as well as the depth of the cone specimens were smaller in the LEEP group than in the CKC group (P < 0.05). The operating time in the LEEP group was significantly shorter than that of the CKC group (P < 0.05). Although thermal artifacts of margin were found in 8.2% of LEEP specimens, there was no difficulty in histological interpretation. Furthermore, the postoperative complications were similar in both groups. CONCLUSION: The findings of this study demonstrate that the LEEP is a convenient, safe, and effective treatment for the management of cervical dysplasia. Cone specimens obtained during LEEP are adequate for thorough histological evaluation of cervical dysplasia.     

Successful conservative management of a large iatrogenic vesicovaginal fistula after loop electrosurgical excision procedure

Untreated hydrosalpinx is known to decrease in vitro fertilization success. We report on 4 patients with hydrosalpinx for whom fresh transfers of 11 good quality embryos did not produce a pregnancy; however, frozen blastocyst transfers in natural cycles resulted in several successful pregnancies, with an implantation rate of 60% (9/15 blastocysts implanted).     

宫颈电环切除术后至妊娠的时间间隔对妊娠结局的影响

目的：探讨宫颈电环切除术（LEEP）术后至妊娠的时间间隔对妊娠结局的影响。方法：收集2000年-2010年LEEP术后准备生育的106例妇女为病例组,随机抽取同期门诊准备生育、无宫颈治疗史的106例健康妇女为对照组。比较两组的妊娠率及妊娠方式。按LEEP术后至受孕的时间间隔,将病例组中妊娠者分为3组：术后12月内、术后13-24月和25月后组,比较3组孕妇的妊娠结局。结果：病例组中1例失访。病例组与对照组的妊娠率分别为98.10%（103/105）和99.06%（105/106）;自然妊娠率分别为99.03%（102/105）和99.05%（104/106）;剖宫产率分别为37.14（39/105）和35.85%（38/106）,两组比较均无显著差异（P〉0.05）。两组的剖宫产原因不同,病例组中因高龄因素行剖宫产者显著高于对照组（P=0.001）。病例组中术后12个月内、13-24个月和25个月后妊娠者分别有27例、43例和32例,3组的流产、早产、胎膜早破和剖宫产率均无显著差异（P〉0.05）。结论：LEEP术后至妊娠的时间间隔不影响患者的受孕及妊娠结局。     

Predictors of cervical dysplasia after the loop electrosurgical excision procedure in an inner-city population

OBJECTIVE: To identify factors associated with persistence or clearance of cervical intraepithelial neoplasia (CIN) following loop electrosurgical excision procedure (LEEP) in high-risk patients. STUDY DESIGN: In a retrospective database review, we identified 343 patients who had 2 LEEP procedures or LEEP followed by hysterectomy for CIN at Grady Memorial Hospital. We compared margin status, endocervical curettage (ECC) at LEEP and follow-up cytology for patients characterized as having persistent or nonpersistent dysplasia. RESULTS: Seventy-nine percent (71/90) of patients with positive LEEP margins had persistent disease vs. 50% (45/90) with negative margins (odds ratio [OR]=3.7, 95% confidence interval [CI] 1.9-7.2, P<.0001). Ninety-one percent (29/32) with positive margins and positive ECC had persistent disease vs. 47% (26/55) with negative margins and negative ECC (OR=10.8, 95% CI 2.9-39.6, P<.0001). Sixty-eight percent (149/218) with at least 1 positive Pap smear following LEEP had persistent disease vs. 37% (11/30) with all negative follow-up Pap smears (OR = 3.7, 95% CI 1.7-8.3, P = .0007). CONCLUSION: Although the risk of persistent CIN increased with positive LEEP margins, ECC and cytology, these variables, when negative, offered no ensurance of a future disease-free state in this high-risk population.     

Pregnancy outcome after loop electrosurgical excision procedure for the management of cervical intraepithelial neoplasia

Objective: Previous studies have shown conflicting results on the outcome of pregnancy following loop electrosurgical excision procedure (LEEP). The purpose of this study was to evaluate whether LEEP affects the outcome of pregnancy after 20 weeks gestation. Methods: This is a matched cohort study of all women who had a LEEP for a biopsy-confirmed cervical intraepithelial neoplasia (CIN) in between December 1995 and December 2000 and subsequently delivered (after 20 weeks gestation) at the University Hospital of Northern Norway. Women who had an ectopic pregnancy or an abortion (spontaneous or induced) following LEEP were excluded from analysis. Two controls matched for the date of delivery, age, parity, previous obstetric history and smoking habit were identified for each case using routinely entered data from the birth register. The main outcome measures were the duration of pregnancy and birth weight. Other variables recorded included the grade of cervical dysplasia, size of the electrosurgical loop, age, parity, pregnancy complications, mode of delivery, and perinatal outcome. Results: Of a total of 428 women of reproductive age who had LEEP performed during the study period, 89 had a pregnancy after the procedure. Ten women were excluded (three ectopic pregnancies, two induced abortions and five spontaneous abortions) from the study. Data from 79 women whose pregnancies progressed beyond 20 weeks and 158 matched controls were analysed. The mean age at the time of LEEP was 27 (range 19–36) years. The histological diagnosis was normal in 3 (3.8%), CIN1 in 5 (6.3%), CIN2 in 18 (22.8%), and CIN3 in 53 (67.1%) of the cases. Overall, mean gestation at delivery (38.3 vs. 39.1 weeks), mean birth weight (3,412 vs. 3,563 g), prevalence of preterm birth (11.4% vs. 10.8%) and low birth weight (10.1 vs. 5.1%) were not significantly different among the cases and controls. But when a relatively large loop (25 mm) had been used, the risk of preterm delivery (odds ratio 4.0) and low birth weight (odds ratio 14.0) was significantly higher than in controls. Pregnancy complications occurred more frequently (20 vs. 7%; p=0.006) among the cases than the controls. Conclusion: LEEP in women with CIN did not significantly increase the risk of low birth weight or preterm birth in subsequent pregnancy in comparison to their controls, except when the size of electrosurgical loop was relatively large. However, the prevalence of pregnancy complications was significantly higher after LEEP.     

Residual lesions in uterine specimens after loop electrosurgical excision procedure in patients with CIN

Objective

To identify the risk factors for residual lesion in hysterectomy specimens after loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN).

Methods and results

We retrospectively analyzed the clinical data of 594 patients who underwent total hysterectomy after LEEP for CIN at the International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University between July 2006 and June 2015. Among the 594 patients, there were no residual lesions in uterine specimens of 409 (68.9%) patients; residual CIN1 was found in 24 (4%) patients, CIN2 and CIN3 in 142 (23.9%) patients, and cervical cancer in 19 (3.2%) patients. On univariate analysis age, menopausal status, margin involvement, lesion grade, abnormal endocervical curettage (ECC) result, and persistent human papillomavirus (HPV) infection post operation were significantly associated with residual lesions after LEEP (P?<?0.05). Multivariate regression analysis using the logistic regression model showed abnormal ECC result and persistent HPV positivity to be independent risk factors for residual lesions after LEEP. LEEP with positive margins and persistent HPV infection were also associated with high risk of invasive cervical cancer in CIN2+ patients.

Conclusions

Abnormal ECC result and post-treatment HPV infection are predictors of residual lesion after LEEP. In combination, they could be useful for risk stratification and selection of the management approach. Postmenopausal CIN2+ patients with positive margins and persistent postoperative HPV infection may have high risk of cervical invasive cancer.

     

The effect of loop electrosurgical excision procedure on future pregnancy outcome

OBJECTIVE: To estimate whether the loop electrosurgical excision procedure (LEEP) is associated with an adverse effect on the outcome of subsequent pregnancies. METHODS: A retrospective cohort study was performed. The study group comprised women who had a LEEP in Halifax County between 1992 and 1999 and then had a subsequent singleton pregnancy of greater than 20 weeks of gestation with delivery at the IWK Health Centre in Halifax, Nova Scotia. The comparison group comprised women with no history of cervical surgery who were matched for age, parity, smoking status, and year of delivery. There were 571 women in each group. The primary outcome was rate of preterm delivery at less than 37 weeks of gestation. Secondary outcomes included delivery at less than 34 weeks and various neonatal and maternal outcomes. The effect of specific LEEP characteristics was analyzed separately. RESULTS: Women who had a LEEP were more likely to deliver preterm overall (7.9% versus 2.5%; odds ratio [OR] 3.50, 95% confidence interval [CI] 1.90-6.95; P < .001) and to deliver preterm after premature rupture of membranes (PROM) (3.5% versus 0.9%; OR 4.10, 95% CI 1.48-14.09). The increase in delivery at less than 34 weeks was not statistically significant (1.25% versus 0.36%; OR 3.50, 95% CI 0.85-23.49; P = .12). Women with LEEP also delivered more low birth weight (LBW) infants (5.4% versus 1.9%; OR 3.00, 95% CI 1.52-6.46; P = .003). There were no differences in other neonatal or maternal outcomes. No association was found between the characteristics of the LEEP, including depth, and the rate of preterm delivery. CONCLUSION: Loop electrosurgical excision procedure is associated with an increased risk of overall preterm delivery, preterm delivery after PROM, and LBW infants in subsequent pregnancies at greater than 20 weeks of gestation. Women who are considering future pregnancies should be counseled about these risks during informed consent for LEEP. LEVEL OF EVIDENCE: II-2.