LLETZ make it simple: Anxiety, pain and treatment outcomes with outpatient large loop excision of the transformation zone under local anaesthesia.

BACKGROUND: Large loop excision of the transformation zone (LLETZ) is the preferred treatment for cervical intraepithelial neoplasia due to its effectiveness and ability to be performed in an outpatient setting under local anaesthesia (LA). Although current guidelines recommend that most LLETZ can be performed under LA, there is paucity in clinical data of patients' perspectives of outpatient LLETZ. AIM: Determining patient acceptability of outpatient LLETZ through assessment of anxiety and pain scores, and comparing treatment outcomes with current standards in terms of margins status, negative histology, short-term morbidity rates and follow-up attendance. MATERIALS AND METHODS: This study was conducted at a tertiary hospital over two years (2014-2016). Patients undergoing outpatient LLETZ completed a three-part questionnaire (before, immediately after and 4-6 weeks post-procedure). RESULTS: One hundred and five patients underwent outpatient LLETZ. Mean pain score was 2 (range 0-8). Pre-procedure anxiety was common but most resolved post-procedure. Women who did not have a prior LLETZ discussion were more likely to report moderate-severe anxiety levels pre-procedure, compared with women who did (odds ratio 3.00, 95% CI 1.11-8.09, P = 0.030). There were no differences found in pain scores when comparing pre-procedure anxiety levels, prior discussion of LLETZ or mode of anaesthesia. Specimen margins were involved in 42.9%. No association was found between positive cervical margin status and age, pre-procedure anxiety or post-procedure pain scores. Most patients were satisfied and attended follow-up appointments. CONCLUSION: Large loop excision of the transformation zone under LA is a well-tolerated procedure with high satisfaction and follow-up rates. Clinicians need to initiate early discussions regarding treatment to minimise procedure-related anxiety.

Lidocaine Spray Versus Paracervical Block During Loop Electrosurgical Excision Procedure: A Randomized Trial.

OBJECTIVE: The aim of the study was to compare the effectiveness of pain control between lidocaine spray (LS) and paracervical block (PB) with lidocaine during the loop electrosurgical excision procedure (LEEP). MATERIALS AND METHODS: A single-blinded randomized controlled trial was conducted on 132 women who underwent LEEP of the cervix. The participants were randomly allocated to either a PB group or a LS group. The PB group participants were anesthetized by PB using 10 mL of 2% lidocaine with 1:100,000 of epinephrine. The LS group participants were locally anesthetized with four puffs (40 mg) of 10% LS, which was applied thoroughly to the cervix. Pain scores, using 10-cm visual analog scales, were obtained and compared for participants in both groups during anesthesia, during excision and 30 minutes after excision. RESULTS: A total of 132 LEEPs were performed with 66 in LS group and 66 in PB group. The mean (SD) pain scores during excision were 5.2 (2.4) in the LS group and 4.2 (3.3) in the PB group (mean difference = 1.1, 95% CI = 0.8 to 2.1, p = .033), which was within the nonclinically significant margin of this study. The baseline pain score after speculum examination was not significantly different in both groups. There was no adverse effect in the LS group compared with eight cases in the PB group (tinnitus, numbness, palpitation or tachycardia, and hypertension). CONCLUSIONS: The local 40 mg of 10% LS can be used to substitute for PB for pain control during LEEP of the cervix. It also resulted in fewer adverse effects.

Análisis prospectivo de LEEP realizados sin anestesia en la consulta de patología cervical / Prospective analyses of outpatient LEEP carried out in cervical pathology clinic without anesthesia

Objetivo: determinar si la técnica Loop Electrosurgical Excision Procedure es un procedimiento efectivo y seguro para realizarlo en consulta ambulatoria de patología cervical. Material y métodos: estudio observacional prospectivo que incluye 156 pacientes que se les realiza Loop Electrosurgical Excision Procedure en consulta ambulatoria, sin anestesia, durante un periodo de seguimiento de 84 meses (7 años). Se excluyen 24 pacientes. Se analizan diferentes variables epidemiológicas, técnica, estado de bordes quirúrgicos, complicaciones y tolerancia al dolor. Resultados: la edad media de las pacientes fue de 35,7 años con inicio de la actividad sexual 17,9 años y 9 parejas sexuales de media. El diámetro mayor de las piezas analizadas fue de 1,7 cm. En el 18 pacientes (13,6%) los bordes quirúrgicos fueron reportados "afectos". Presentamos en 3 casos (2,3%) daño de la mucosa vaginal y un caso (0,8%) hemorragia tardía. La tolerancia al dolor fue satisfactoria en 121 pacientes (91,7%) y solo 1 paciente (0,8%) precisó de anestésico local. Discusión: el Loop Electrosurgical Excision Procedure es un procedimiento que puede ser realizado en consulta bajo imagen colposcopica en forma segura, efectiva y sin anestesia (AU)

Objective: To determine if cervical conization realized by leep procedure is an effective and safe procedure in an outpatient cervical pathology clinic. Material and methods: Prospective cohort study which includes 156 patients, who experienced a Loop Electrosurgical Excision Procedure procedure in an outpatient clinic without anesthesia, in a 84 months follow-up period (7 years). 24 patients are excluded. Different epidemiological variables and techniques were analyzed, as well as excision margins state, complications and pain tolerance. Results: The patients average age were 35.7 years old, with an onset of sexual activity median age of 17.9 years and a average number 9 sexual partners. The largest diameter of the analyzed pieces was 1.7 cm. In 18 patients (13.6%), excision margins were reported as "affected". In 3 cases (2.3%) the vaginal mucosa became damaged and one patient (0.8%) had late bleeding. The pain tolerance was satisfactory in 91.7% cases and local anaesthetic was administered to one patient only (0.8%). Discussion: Loop Electrosurgical Excision Procedure procedure can be carried out in an outpatient clinic under colposcopic vision being a safe, effective and without need of anesthesia procedure (AU)

The role of cervical cultures to guide perioperative antibiotics in cervical cerclage - a retrospective analysis of 65 consecutive cases.

OBJECTIVE: The objective of this study is to examine results of bacterial cultures of the cervix prior to cerclage placement and how these may be used to guide prophylactic antibiotics. METHODS: All patients undergoing cerclage between 2000 and 2003 in a single, large community hospital were evaluated for indication for cerclage, signs and symptoms on presentation, transvaginal ultrasound cervical length findings, type of cerclage placed, type of anesthesia used, cervical culture taken, tocolytics given, gestational age at delivery, and complications surrounding delivery. RESULTS: Sixty-five cerclages were performed between 2000 and 2003, 13 (20%) prophylactic, 47 (72%) therapeutic, and five (8%) emergent. Cervical cultures were obtained in 85% of patients, of which 40% were negative resulting in no antibiotics given. In the remaining 45%, one or more pathogens were isolated and antibiotics were given according to sensitivities reported. Fifty-five of 65 patients (84%) delivered after 32 weeks gestation and a latency > 60 d was seen in 84%. The incidence of chorioamnionitis and PPROM was low. CONCLUSION: Bacterial cultures of the cervix prior to cerclage show variable colonization and antibiotic sensitivities and, there is no single antibiotic, chosen empirically, that will cover all pathogens.

A postpartum haemorrhage package with condom uterine balloon tamponade: a prospective multi-centre case series in Kenya, Sierra Leone, Senegal, and Nepal.

OBJECTIVE: To evaluate the effectiveness and safety of an ultra-low-cost uterine balloon tamponade package (ESM-UBT™) for facility-based management of uncontrolled postpartum haemorrhage (PPH) in Kenya, Sierra Leone, Senegal, and Nepal. DESIGN: Prospective multi-centre case series. SETTING: Facilities in resource-scarce areas of Kenya, Sierra Leone, Nepal, and Senegal. POPULATION: Women with uncontrolled postpartum haemorrhage in 307 facilities across the four countries. METHODS: A standardised ESM-UBT package was implemented in 307 facilities over 29 months (1 September 2012 to 1 February 2015). Data were collected via a multi-pronged approach including data card completion, chart reviews, and provider interviews. Beginning in August 2014, women who had previously undergone UBT placement were sought and queried regarding potential complications associated with UBT use. MAIN OUTCOME MEASURES: All-cause survival, survival from PPH, and post-UBT use complications (surgery, hospitalisation, antibiotics for pelvic infection) associated with UBT use. RESULTS: 201 UBTs were placed for uncontrolled vaginal haemorrhage refractory to all other interventions. In all, 38% (71/188) of women were either unconscious or confused at the time of UBT insertion. All-cause survival was 95% (190/201). However, 98% (160/163) of women survived uncontrolled PPH if delivery occurred at an ESM-UBT online facility. One (1/151) potential UBT-associated complication (postpartum endometritis) was identified and two improvised UBTs were placed in women with a ruptured uterus. CONCLUSIONS: These pilot data suggest that the ESM-UBT package is a clinically promising and safe method to arrest uncontrolled postpartum haemorrhage and save women's lives. The UBT was successfully placed by all levels of facility-based providers. Future studies are needed to further evaluate the effectiveness of ESM-UBT in low-resource settings. TWEETABLE ABSTRACT: Evidence for ESM-UBT as a clinically promising and safe method to arrest uncontrolled PPH and save women's lives.

[The survivability of patients with cervical cancer of IIB stage].

To the present tense finally mine-out not tactic of treatment of patients with the cervical cancer (CC) of IIB stage, but in the standards of diagnostics and treatment there are different variants of treatment of this pathology, and choice, most optimum, as a rule, depends on subjective opinion of doctor. Consequently, purpose of our work--to promote efficiency of treatment of patients on CC IIB the stage, by application of neoadjuvant chemotherapy in the combined treatment. The results of treatment are analysed 291 patients on CC IIB stages which got radical treatment in Ivano-Frankivsk OKOD from 1998 to 2013 years. At the use of neoadjuvant chemotherapy index of general 5-years-survival and nonrecurrence survivability made 74.4% and 70.8%, and to preoperative chemotherapy--70.8% and 68.3% accordingly. At application of independent chemoradial therapy, to the index of general 5-years-survival and nonrecurrence survivability was 51.1% and 49.3%, accordingly. It is not exposed reliable difference (P < 0.05) at comparison of indexes of 5-years-survivability of patients which have got the combined methods of treatment, but a reliable difference is exposed when compared to patients which have got independent chemoradial therapy (P > 0.05). Consequently, application of the combined methods of treatment of patients of CC IIB stages were improved by indexes general 5-years and to nonrecurrence survivability by comparison to independent cheradial therapy. .

Temperature superposition for fast computation of 3D temperature distributions during optimization and planning of interstitial ultrasound hyperthermia treatments.

PURPOSE: A temperature superposition method has been developed for fast optimisation and planning of interstitial hyperthermia treatments with convectively cooled multi-transducer ultrasound applicators integrated within high dose rate (HDR) brachytherapy catheters. METHODS: Steady-state temperature distributions produced by individual tubular transducers capable of directional heating were pre-computed using finite element models (FEM) methods. The composite temperature distributions generated by multi-applicator implants were approximated as superposition sums of the pre-computed temperature profiles. Composite temperature distributions produced by the multi-applicator implants were also computed using accurate but computationally expensive FEM methods (considered here as the validation standard). Both methods were used for temperature calculation on a range of test implant geometries and representative patient cases (HDR implants in prostate (n = 13) and cervix (n = 2)), with optimised treatment plans created for the latter. RESULTS: Difference between temperatures calculated by the superposition and FEM methods was below 0.37°C (95% confidence interval) in test implants at clinically relevant acoustic intensities (0.3-2.0 W/cm²) and blood perfusion (2 kg/m³/s). Difference in 41°C isothermal volumes was below 8.3%. Superposition-based optimisations followed by FEM forward calculations (hybrid plans) were completed 4-7 times faster than FEM-only plans (FEM optimisation + FEM forward). Mean T90, T50 and T10 values from both plans were within 0.3°C, 0.4°C and 0.45°C respectively, and the mean acoustic intensities were within 0.23 W/cm². CONCLUSIONS: Temperature superposition provides a fast technique for forward or optimised planning of interstitial ultrasound hyperthermia treatments with calculations comparable to more accurate but time consuming FEM methods.

Scaleable manufacture of HIV-1 entry inhibitor griffithsin and validation of its safety and efficacy as a topical microbicide component.

To prevent sexually transmitted HIV, the most desirable active ingredients of microbicides are antiretrovirals (ARVs) that directly target viral entry and avert infection at mucosal surfaces. However, most promising ARV entry inhibitors are biologicals, which are costly to manufacture and deliver to resource-poor areas where effective microbicides are urgently needed. Here, we report a manufacturing breakthrough for griffithsin (GRFT), one of the most potent HIV entry inhibitors. This red algal protein was produced in multigram quantities after extraction from Nicotiana benthamiana plants transduced with a tobacco mosaic virus vector expressing GRFT. Plant-produced GRFT (GRFT-P) was shown as active against HIV at picomolar concentrations, directly virucidal via binding to HIV envelope glycoproteins, and capable of blocking cell-to-cell HIV transmission. GRFT-P has broad-spectrum activity against HIV clades A, B, and C, with utility as a microbicide component for HIV prevention in established epidemics in sub-Saharan Africa, South Asia, China, and the industrialized West. Cognizant of the imperative that microbicides not induce epithelial damage or inflammatory responses, we also show that GRFT-P is nonirritating and noninflammatory in human cervical explants and in vivo in the rabbit vaginal irritation model. Moreover, GRFT-P is potently active in preventing infection of cervical explants by HIV-1 and has no mitogenic activity on cultured human lymphocytes.

Outpatient management of abnormal smears.

OBJECTIVES: To review the results of the first 403 women treated at the Abnormal Smear and Colposcopy Unit with special reference to the utility, efficacy, acceptability and economy of in-office treatment of cervical lesions by large loop or Fischer cone excision. DESIGN: Retrospective chart review of consecutive patients treated following, referral with an abnormal smear or abnormal cervical morphology, between 1 September 1996 and 1 August 2001. SETTING: Inner city private practice. SAMPLE: A total of 403 consecutive General Practitioner referred women. METHODS: Details of referral smear result, colposcopically directed biopsy result, subsequent treatment type and histological result including assessability, number of specimens submitted, complications and follow-up assessment were extracted at chart review. Costs of public hospital inpatient and outpatient care, supplied by the Casemix and Clinical Benchmarking Service, Mater Miseraecordae Public Hospitals (with permission to publish), were compared with Medicare rebates. MAIN OUTCOME MEASURES: A total of 187 women were treated by large loop excision of the transformation zone, and 216 by Fischer cone excision. The number of women who were treated as outpatients under local anaesthetic were 395, while eight patients were treated under general anaesthesia as inpatients. There was poor correlation between referring smear, biopsy and subsequent treatment results. Eight patients had abnormal cytology at follow-up, of whom two have been retreated. Three patients had primary or secondary bleeding requiring treatment and two developed cervical stenosis. Outpatient private practice treatment of women with abnormal smears allows significant savings to the public purse over public or private hospital care. CONCLUSIONS: Outpatient treatment of women with abnormal smears, using the Fischer cone technique, is safe, well accepted, effective and the most cost efficient solution to this public health problem.

[Paracervical anesthesia in hysteroscopy and transcervical surgery]. / Paracervikální anestezie pri hysteroskopii a transcervikální chirurgii.

OBJECTIVE: To evaluate the efficacity of local-paracervical anaesthesia in hysteroscopy and transcervical surgery. DESIGN: Prospective study. SETTING: Department of Obstetrics and Gynaecology, 1st medical Faculty, Charles University, Prague. METHODS: In 1998 we performed 144 hysteroscopic procedures under local anaesthesia--paracervical block. In 47 (32.6%) cases we performed transcervical surgery. As anaesthetic agent we used bupivacain (0.25%, Marcain, Astra) combined with an intravenous sedative--midazolam (Dormicum, Hoffman-LaRoche). RESULTS: In 130 (90.2%) cases patients evaluated the procedure as comfortable, in 7 (4.86%) cases the procedure caused discomfort and in 7 (4.86%) cases we used general anaesthesia. CONCLUSION: Paracervical anaesthesia is a safe method for hysteroscopy and transcervical surgery due to its minimal invasivity.

A randomized study of local or general anesthesia for laser conization of the cervix.

Laser Conization of the cervix was performed in both inpatient and outpatient settings with either local or general anesthesia. All of the patients included had abnormal cervical smears, abnormal colposcopic findings and were allocated to one of two groups, A and B. Patients in group A had general anesthesia while patients in group B had only local anesthesia. A standard operative technique, was used and all patients had estimation of blood loss, recording of operative time, surgical suite time, anesthesia induction time, and assessment of postoperative pain and morbidity. Statistical analysis was performed using the student t-test. We concluded that laser conization of the cervix can be performed more cheaply with local anesthesia than with general anesthesia and with little discomfort, less nausea, and vomitting.

[Laser conization guided by endocervical staining with methylene blue]. / Conizzazione laser guidata mediante colorazione endocervicale con blu di metilene.

The authors report their experience of the use of a vital stain--methylene blue--as a surgical guide in laser cervical conization for CIN2-CIN3/CIS. During the period 1 October 1991-31 December 1992 a total of 40 laser cervical conizations were performed under local anesthesia using a CO2 laser connected to a microhandpiece and colposcope in patients with exo-endocervical lesions which were histologically positive for CIN2-CIN3/CIS. In 33/40 patients an aqueous solution of 1% methylene blue was introduced preoperatively in the endocervix using a cotton-wool bud with consequent impregnation of the pseudoglandular crypts: laser biopsy was performed along the guidelines of the stain itself. This enabled the direction of resection to be varied: in 3 patients due to an anomalous and eccentric direction of cervical canal; in 10 patients to remove glandular structures surrounding or underneath lesions; in 8 patients following pseudoglandular section to carry out deep vaporization (3 patients) or correct cutting edges (5 patients). The apex and edges of the cone were always intact. Fourteen patients completed a 12-month follow-up and a further 6 were followed up for 9 months; only 1/14 patients (with AIDS) showed recidivation after 1 year. In the authors' experience the use of a vital stain as a guide during laser cervical cone biopsy is an easily used method which ensures the greatest possible respect for healthy cervical structures, also in order to preserve fertility in young patients.

Conización bajo anestesia local una buena alternativa

Se presenta un estudio que resume la experiencia obtenida en SOLCA, Quito, de conización cervical practicada con anestésico local, la misma que, en un 23 por ciento fue ejecutada por discordancia entre citología, colposcopia e histopatológico, 29 por ciento porque las biopsias no lograban definir el grado de infiltración tumoral, y 48 por ciento fueron terapéuticas. Este procedimiento reduce morbilidad y principalmente los costos y días de hospitalización.

Local anesthesia for cryosurgery on the cervix.

Forty-five patients were evaluated in a prospective, randomized study to determine the effectiveness of a local injection of lidocaine in reducing pain during cervical cryosurgery. Study patients received a submucosal cervical injection of 1% lidocaine with a 1:100,000 dilution of epinephrine. Control patients did not receive an injection. Both groups received a single dose of naproxen sodium or ketoprofen prior to the procedure. The patient and the observing nurse recorded the pain experienced with a visual analog scale (VAS). Nurse and patient response for the control and study groups showed a high correlation (r = .573 and P < .01, r = .673 and P < .001, respectively). The mean VAS score recorded for the 26 control patients was 4.27, significantly greater than the mean score for the 19 study patients, 1.16 (P < .001). These findings indicate that a submucosal local injection of lidocaine with epinephrine is effective in reducing pain during cervical cryosurgery.

[Electrosurgical loop excision as diagnostic and simultaneously therapeutic intervention in cervical intraepithelial neoplasia]. / Elektrochirurgische Schlingenexzision als diagnostischer und gleichzeitig therapeutischer Eingriff bei der zervikalen intraepithelialen Neoplasie.

109 women referred to our center for colposcopy because of suspicious cervical cytology and in whom an abnormal epithelial pattern was diagnosed on colposcopy, or in whom a discrepancy between cytology and colposcopy was encountered, concomitantly underwent loop electrosurgical excision procedure as an outpatient procedure. All removed specimens were examined and no invasive cancer was found in any of them. No serious complications occurred. Ambulatory loop electrosurgical excision procedure appears to be a cost-effective and well tolerated treatment modality for the management of women with cervical intraepithelial neoplasia, with the advantage that this conservative procedure allows histologic examination of the removed tissue.

Is transcutaneous electrical nerve stimulation of any value during cervical laser treatment?

OBJECTIVE: To assess the value of transcutaneous electrical nerve stimulation (TENS) during cervical laser therapy. DESIGN: Randomized three arm controlled clinical trial comparing (i) TENS, (ii) local anaesthetic and (iii) TENS plus local anaesthetic (direct infiltration of 2% lignocaine and 0.03 iu/ml octopressin). SETTING: Colposcopy Unit adapted to run randomized trials. SUBJECTS: 100 women with CIN and no previous experience of cervical surgery. MAIN OUTCOME MEASURE: Visual linear analogue pain scores. RESULTS: The median pain score associated with TENS was greater than the score associated with local anaesthesia (23% compared with 17%; P = 0.1). Combining TENS with local anaesthesia did not further reduce pain scores. CONCLUSION: Although there was considerable consumer satisfaction with TENS it provided no additional pain relieving effect in addition to direct infiltration of lignocaine and it is inferior to lignocaine alone. We are unable to advocate the use of TENS for laser treatment of the cervix.

A randomized trial of Citanest with Octapressin for relief of pain associated with laser vaporization of the cervix.

Fifty women undergoing laser vaporization of the cervix for cervical intraepithelial neoplasia were randomly allocated to one of two groups. In one group the patients received no anaesthesia, in the other the ectocervix was infiltrated with 2 ml of Citanest with Octapressin (prilocaine 3% with 0.03 i.u./ml. of felypressin) immediately before the procedure. The pain experienced by each group was assessed immediately after treatment by visual analogue and verbal rating scales. The pain experienced by those women receiving local anaesthesia was significantly reduced as assessed by the visual analogue scale (P = 0.011) and this reduction was not quite significant by the verbal rating scale (P = 0.06). The Citanest group had less troublesome bleeding but the difference in bleeding between the two groups was not significant.

Outpatient cervical conization with the CO2 laser.

Ninety-six patients with grade 3 cervical intraepithelial neoplasia (CIN) were treated with CO2 laser conization, and 45 were treated with cold-knife conization. Local anesthesia was used in 83% of the patients in the laser group; the rest received general anesthesia. In the laser group seven patients developed peri- and postoperative hemorrhages. Hemorrhages occurred among four of those treated with cold-knife conization. Laser conization with local anesthesia was well tolerated and can be recommended as an outpatient procedure for patients with endocervical grade 3 CIN or lesions suggestive of microinvasive cancer.