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Effect of age and cone dimensions on cervical regeneration: an Italian multicentric prospective observational study.

ABSTRACT: OBJECTIVES:To evaluate cervical regeneration at 6?months following excisional treatment for high-grade cervical intraepithelial neoplasia (CIN), and to investigate the effect of cone dimensions, age of patients and technique of excision on the efficacy of the regeneration process. DESIGN:Prospective observational multicentric study. SETTING:Three tertiary care and research centres. PARTICIPANTS:Among the 197 eligible women of childbearing age, older than 25 years of age, undergoing for the first time a loop electrosurgical excision procedure or carbon dioxide laser cervical excision for a high-grade CIN at the colposcopy-directed cervical punch biopsy, and with a final diagnosis of high-grade CIN, 165 completed the 6-month follow-up and were included in the analysis. PRIMARY OUTCOME MEASURES:The cervical length and volume regeneration (%) after 6?months from procedure were determined by three-dimensional ultrasound, and the correlation of regeneration with cone dimensions, age and excision technique was evaluated. RESULTS:The mean±SD?cervical length regeneration at 6?months was 89.5%±6.3%?and the mean±SD?cervical volume regeneration was 86.3%±13.2%. At the multivariate analysis, a significant and independent inverse correlation between excised cone length and cervical regeneration emerged (r=-0.39, P<0.001). A significantly negative trend in length regeneration at 6?months from procedure with an increasing class of cone length was found (P<0.001). No significant association was found in relation with patient age at the time of procedure or with the technique of excision. CONCLUSIONS:Cervical length regeneration at 6?months from excisional treatments is negatively affected by an increasing cone length but not from the age of the patient or the technique of excision. While still achieving equal clinical efficacy, it is crucial to contain cone dimensions, in order to favour a greater length regeneration, reducing the cervical harm and the potential future obstetric complications.

SUBMITTER: Ciavattini A

PROVIDER: S-EPMC5875629 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Effect of age and cone dimensions on cervical regeneration: an Italian multicentric prospective observational study.

Ciavattini Andrea A Delli Carpini Giovanni G Moriconi Lorenzo L Clemente Nicolò N Montik Nina N De Vincenzo Rosa R Del Fabro Anna A Buttignol Monica M Ricci Caterina C Moro Francesca F Sopracordevole Francesco F

BMJ open 20180319 3

<h4>Objectives</h4>To evaluate cervical regeneration at 6 months following excisional treatment for high-grade cervical intraepithelial neoplasia (CIN), and to investigate the effect of cone dimensions, age of patients and technique of excision on the efficacy of the regeneration process.<h4>Design</h4>Prospective observational multicentric study.<h4>Setting</h4>Three tertiary care and research centres.<h4>Participants</h4>Among the 197 eligible women of childbearing age, older than 25 years of ...[more]

PMID: 29555794

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Project description:OBJECTIVE:To evaluate the risk of progression to high-grade squamous intraepithelial lesion (HSIL) (CIN2-3) or invasive cancer in women with histopathological diagnosis of low-grade squamous intraepithelial lesion (LSIL) (CIN1), managed in a long-term observational approach up to 5 years. DESIGN:Retrospective cohort study. SETTING:Four tertiary referral hospital. PARTICIPANTS:434 women with adequate colposcopy and complete colposcopic charts were included in the present analysis. Women with glandular lesions on the referral cytology or previous diagnosis of cervical dysplasia or invasive cervical cancer or with synchronous vaginal, or with HIV infection or immunodepression were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES:The main study outcome was the rate of progression to histopathological HSIL (CIN2-3) or invasive cancer at any time during 5 years of follow-up. The possible risk factors were also evaluated. As secondary outcome, we analysed the possible risk factors at the 24-month evaluation for histopathological HSIL (CIN2-3) or invasive cancer progression between 2 and 5 years from initial diagnosis. RESULTS:A progression to histopathological HSIL (CIN2-3) was found in a total of 32 (7.4%) cases during 5 years of follow-up. A histopathological diagnosis of HSIL (CIN3) was found in four patients (0.9%) and no case of invasive cancer was detected. High-grade cytology at inclusion and the presence of a positive high-risk human papillomavirus (HR-HPV) DNA test at 2 years from inclusion maintained a significant correlation with the risk of histopathological progression to HSIL (CIN2-3). CONCLUSIONS:The results of our study showed a low rate (7.4%) of histopathological progression to HSIL (CIN2-3) in women with LSIL (CIN1) diagnosis during long-term follow-up up to 5 years. In case of positive HR-HPV DNA test at the 2 years evaluation an excisional treatment could be the preferred choice to prevent progression to HSIL (CIN2-3) in the following years, preferring a continuation of follow-up in case of HR-HPV DNA negative result.

Project description:BackgroundShort cervical length measured during the second trimester of pregnancy is an important risk factor for spontaneous preterm birth (sPTB). The aim of this study is to identify the association between mid-pregnancy cervical length (CL) and gestational age at birth in asymptomatic singleton pregnant women.MethodsThis is a prospective cohort study involving singleton pregnant women who participated in the screening phase of a Brazilian multicenter randomized controlled trial (P5 trial) between July 2015 and March 2019. Transvaginal ultrasound to measure CL was performed from 18 to 22 + 6 weeks. Women with CL ≤ 30 mm received vaginal progesterone (200 mg/day) until 36 weeks' gestation. For this analysis we considered all women with CL ≤ 30 mm receiving progesterone and a random selection of women with CL > 30 mm, keeping the populational distribution of CL. We obtained prognostic effectiveness data (area under receive operating characteristic curve (AUC), sensitivity and specificity and estimated Kaplan-Meier curves for preterm birth using different CL cutoff points.ResultsWe report on 3139 women and identified a negative association between cervical length and sPTB. CL ≤ 25 mm was associated with sPTB < 28, sPTB < 34 and sPTB < 37 weeks, whereas a CL 25-30 mm was directly associated with late sPTB. CL by transvaginal ultrasound presented an AUC of 0.82 to predict sPTB < 28 weeks and 0.67 for sPTB < 34 weeks. Almost half of the sPTB occurred in nulliparous women and CL ≤ 30 mm was associated with sPTB at < 37 weeks (OR = 7.84; 95%CI = 5.5-11.1). The number needed to screen to detect one sPTB < 34 weeks in women with CL ≤ 25 mm is 121 and we estimated that 248 screening tests are necessary to prevent one sPTB < 34 weeks using progesterone prophylaxis.ConclusionsCL measured by transvaginal ultrasound should be used to predict sPTB < 34 weeks. Women with CL ≤ 30 mm are at increased risk for late sPTB.

Project description:IntroductionIn the treatment of patients with chronic pain, whole-body electrostatic therapy using the Elosan Cabin C1 has been proposed as an adjunctive therapy. So far, data on the use of this cabin are limited. Promising results with a significant reduction in pain scores have been obtained in a small group of patients. However, treatment with Elosan Cabin C1 has not been the subject of evaluation in a larger patient population. The aim of this study was to investigate the efficacy and adverse effects of electrostatic treatment in such a population.MethodsProspective, multi-center, observational clinical trial conducted in daily practice in a large adult ambulatory population with chronic pain. Each patient received eight weekly Elosan C1 treatment sessions for up to 9 weeks. Treatment was added to an established conservative pain management. Pain scores (visual analog scale (VAS) 0-100, primary outcome) and sleep quality (seven-point Likert scale, secondary outcome) were assessed before, during, and at the end of the treatment period; quality of life (SF-12: Physical Component Summary = PCS, Mental Component Summary = MCS; secondary outcome) was assessed before and at the end of the treatment period. Subgroup analyses were performed for sex, age, duration of pain, initial pain location, pain entity, and pain medication at the start of treatment.ResultsA total of 192 patients were enrolled, 143 patients (74.5%) had a complete set of 8 treatment sessions. A reduction in pain scores from 68 ± 14 points to 47 ± 22 points was observed (p < 0.001), 65% of patients (responders) had a reduction of > 15 points. Female patients had a significantly better response than male patients with a higher number of responders (76% vs. 38%; p < 0.001). Patients with a pain history < 1 year had a significantly better response than patients with a pain history > 1 year. The Physical Component Summary (PCS) increased from 36 ± 11 to 41 ± 11 (+ 18%, p < 0.001) and the Mental Component Summary (MCS) from 41 ± 7 to 43 ± 7 (+ 6%, p = 0.3). Overall sleep quality improved significantly from 4.6 ± 1.7 to 3.73 ± 1.7 points (p < 0.001), with a higher proportion of responders in the female group (37 vs. 18%; p < 0.034). No serious adverse events were observed during treatment.ConclusionsElectrostatic therapy with Elosan Cabin C1 may be a useful and effective adjunct therapy for patients with chronic pain. The results suggest that female patients and those with a recent history of pain experience the greatest benefit.Trial registrationNCT04818294 (clinicaltrials.gov).

Project description:BackgroundCervical radiculopathy is a relatively common and disabling condition involving local pain in the neck region and pain that radiates into the upper limb. Recent data suggest that cervical traction may effectively reduce disability and pain, with a dose-response relationship. The main aim of this study was therefore to evaluate the mid-term effect of an intensive cervical traction protocol for patients with cervical radiculopathy on disability, and to compare the effects with those reported by non-intensive protocols in the literature.MethodsWe conducted a prospective open observational study of 36 patients referred by their general practitioner for symptoms suggestive of cervical radiculopathy. All patients underwent the same treatment: a 30-minute cervical traction protocol, twice a day, for five consecutive days. The main objective was the evaluation of disability at 3 months. We evaluated at baseline (D1), the end of the protocol (D5) and at mid-term (M3) disability, cervical pain, radiating pain, pain on motor imagery, presence of neuropathic pain and medication consumption. The primary outcome was the proportion of patients for whom the Neck Disability Index improved by more than the minimum clinically important difference of 7 points by M3.ResultsThirty-six patients were included in this study. The Neck Disability Index improved by more than the minimum clinically important difference in 48.3% at M3. Mean Neck Disability Index (p < .001), mean cervical VAS (p < .001), mean radiating VAS (p < .001), and mean VAS for imagined lateral flexion and rotation (p < .002) improved significantly from D1 to D5 and from D1 to M3. Consumption of medication reduced at each time point. The proportion of patients with neuropathic pain reduced from 61.1% at D1 to 33.3% at D5 and 48.3% at M3.ConclusionDisability reduced by more than the minimum clinically important difference in almost half of the participants following the intensive traction protocol. These results are encouraging and suggest that this complex condition can be treated with relatively simple methods.

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Effect of age and cone dimensions on cervical regeneration: an Italian multicentric prospective observational study.

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Effect of age and cone dimensions on cervical regeneration: an Italian multicentric prospective observational study.

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