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This study aimed to evaluate the effectiveness of personalized nursing care in postoperative supplementary surgery for cervical intraepithelial neoplasia grade III (CIN III) patients with positive or high-grade CIN margins after cold knife conization at the Fourth Hospital of Hebei Medical University in Shijiazhuang, China. The primary objective was to assess the impact of personalized nursing intervention on postoperative outcomes, including psychological well-being, self-care ability, quality of life, and postoperative complications. A total of 106 patients undergoing additional surgery after CIN III cold knife conization at the Fourth Hospital of Hebei Medical University from January 2020 to April 2023 were randomly allocated into an observation group (n=53) and a control group (n=53) using a random number table method. Detailed information on the randomization process, including stratification factors and blinding procedures, is provided. The observation group received personalized nursing intervention, while the control group received routine nursing. The retreatment methods, including repeat cold knife conization, total hysterectomy, and radical cervical cancer surgery, were analyzed using appropriate statistical methods. Statistical software was employed for data analysis. Pathological results post-cold knife conization revealed positive margins in 76 cases and pathological upgrades in 30 cases. The consistency rate between post-cold knife conization and post-retreatment pathological results was 75.47%. After the intervention, the observation group exhibited significantly lower SAS and SDS scores and significantly higher ESCA and WHO QOL-100 scores compared to the control group (P < .05), indicating improved psychological well-being and quality of life. The total incidence of postoperative complications in the observation group was 5.66%, significantly lower than in the control group (P < .05). Personalized nursing care in postoperative supplementary surgery for CIN III patients with positive or high-grade CIN margins at the Fourth Hospital of Hebei Medical University improves psychological well-being, self-care ability, quality of life, and reduces postoperative complications. The findings underscore the importance of tailored nursing interventions in enhancing patient outcomes. The inclusion of detailed patient demographics and methodological transparency enhances the generalizability and reliability of the study findings beyond the study setting.

The 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). Our 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). A 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. From 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. The 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.

ObjectiveThe objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer.MethodsFrom April 2010 to March 2019, a prospective, single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2–IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size <2 cm; (4) no lymphovascular space invasion; (5) depth of invasion <10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an ‘inadvertent’ simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the above inclusion criteria and underwent a second surgery with pelvic lymph node dissection only.Results100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23–67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectomy specimen was noted in 1/40 patients—that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0–68.3). Three patients developed recurrent disease within 2 years of surgery—that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%).DiscussionOur prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.

ObjectiveTo evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009).MethodsA multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width ≤0.2 standard deviations of the logit odds of the estimated propensity score.ResultsWe obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively).ConclusionsIn this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.

The trade-off between comparative effectiveness and reproductive morbidity of different treatment methods for cervical intraepithelial neoplasia (CIN) remains unclear. We aimed to determine the risks of treatment failure and preterm birth associated with various treatment techniques. In this systematic review and network meta-analysis, we searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials database for randomised and non-randomised studies reporting on oncological or reproductive outcomes after CIN treatments from database inception until March 9, 2022, without language restrictions. We included studies of women with CIN, glandular intraepithelial neoplasia, or stage IA1 cervical cancer treated with excision (cold knife conisation [CKC], laser conisation, and large loop excision of the transformation zone [LLETZ]) or ablation (radical diathermy, laser ablation, cold coagulation, and cryotherapy). We excluded women treated with hysterectomy. The primary outcomes were any treatment failure (defined as any abnormal histology or cytology) and preterm birth (<37 weeks of gestation). The network for preterm birth also included women with untreated CIN (untreated colposcopy group). The main reference group was LLETZ for treatment failure and the untreated colposcopy group for preterm birth. For randomised controlled trials, we extracted group-level summary data, and for observational studies, we extracted relative treatment effect estimates adjusted for potential confounders, when available, and we did random-effects network meta-analyses to obtain odds ratios (ORs) with 95% CIs. We assessed within-study and across-study risk of bias using Cochrane tools. This systematic review is registered with PROSPERO, CRD42018115495 and CRD42018115508. 7880 potential citations were identified for the outcome of treatment failure and 4107 for the outcome of preterm birth. After screening and removal of duplicates, the network for treatment failure included 19 240 participants across 71 studies (25 randomised) and the network for preterm birth included 68 817 participants across 29 studies (two randomised). Compared with LLETZ, risk of treatment failure was reduced for other excisional methods (laser conisation: OR 0·59 [95% CI 0·44–0·79] and CKC: 0·63 [0·50–0·81]) and increased for laser ablation (1·69 [1·27–2·24]) and cryotherapy (1·84 [1·33–2·56]). No differences were found for the comparison of cold coagulation versus LLETZ (1·09 [0·68–1·74]) but direct data were based on two small studies only. Compared with the untreated colposcopy group, risk of preterm birth was increased for all excisional techniques (CKC: 2·27 [1·70–3·02]; laser conisation: 1·77 [1·29–2·43]; and LLETZ: 1·37 [1·16–1·62]), whereas no differences were found for ablative methods (laser ablation: 1·05 [0·78–1·41]; cryotherapy: 1·01 [0·35–2·92]; and cold coagulation: 0·67 [0·02–29·15]). The evidence was based mostly on observational studies with their inherent risks of bias, and the credibility of many comparisons was low. More radical excisional techniques reduce the risk of treatment failure but increase the risk of subsequent preterm birth. Although there is uncertainty, ablative treatments probably do not increase risk of preterm birth, but are associated with higher failure rates than excisional techniques. Although we found LLETZ to have balanced effectiveness and reproductive morbidity, treatment choice should rely on a woman's age, size and location of lesion, and future family planning. National Institute for Health and Care Research: Research for Patient Benefit.

Background and Objectives: Cervical cancer (CC) represents a significant health concern worldwide, particularly for younger women. Cold knife (CK) conization and carbon dioxide (CO2) laser conization are two techniques commonly used to remove pre-invasive lesions, offering a potential curative intent in cases of incidental diagnosis of CC. This study aimed to assess the clinical implications and pathological outcomes of CK vs. CO2 laser conization for pre-invasive lesions. Materials and Methods: We retrospectively analyzed women who underwent CO2 or CK conization for high-grade preinvasive lesions (CIN2/3, CIS and AIS) between 2010 and 2022. Patient demographics, surgical details and pathological outcomes were collected. Pregnancy outcomes, including composite adverse obstetric rates, and oncological follow-up data, were also obtained. Results: In all, 1270 women were included; of them, 1225 (96.5%) underwent CO2, and 45 (3.5%) underwent CK conization. Overall, the rate of positive endocervical or deep margins was lower with CO2 laser compared to CK (4.3% vs. 13.3%, p = 0.015). Incidental CC was diagnosed in 56 (4.4%) patients, with 35 (62.5%) squamous and 21 (46.6%) adenocarcinomas. In a multivariate regression model, the relative risk for positive endocervical or deep margins is significantly greater in cases of incidental diagnosis of CC (p < 0.01). In cases of incidental diagnosis of CC, we found that the probabilities of having either positive endocervical or deep margins after CO2 laser or CK conization are similar, with a higher risk in case of adenocarcinoma lesion. Among women with CC, 42 (75%) opted for radical treatment, while 14 (25%) underwent a follow-up. Only one woman (7.1%) in the follow-up group, who had undergone CK conization, experienced a composite adverse obstetric outcome. No recurrences were observed after a median follow-up of 53 months. Conclusions: CO2 laser conization achieved a lower positive margin rate overall. CK and CO2 conization appear to be equivalent oncological options for incidental CC.

Objective: The aim of this study was to investigate the influence on fertility and pregnancy outcome in cervical intraepithelial neoplasia (CIN) patients after a loop electrosurgical excision procedure (LEEP) or cold-knife conization (CKC). Methods: 269 patients with CIN-II-III who wanted to conceive were prospectively enrolled in this randomized clinical trial to receive either the LEEP or CKC procedure. Fertility, neonatal and maternal outcomes were observed and compared. Results: 244 evaluable patients were divided into two groups. There were 124 in the LEEP group and 120 in the CKC group. The preterm premature rupture of membranes (16 vs. 8%; p = 0.03), preterm delivery rate (11 vs. 5%; p = 0.04) and low birth weight infants rate (<2,500 g) (10 vs. 6%; p = 0.04) were higher in the CKC group than in the LEEP group, but there was no difference in mean birth weight, cesarean delivery, labor induction, or neonatal intensive care unit admission. There was no case of neonatal mortality. Conclusions: In a prospective evaluation the findings of this study demonstrate that LEEP is safer for future pregnancies when compared to CKC. LEEP should be an appropriate choice for patients with CIN who want to become pregnant later in life.

Background Cold knife conization is usually performed under general anesthesia without intubation. This type of anesthesia is more critical in terms of the properties of the sedative drugs. Remimazolam is a novel ultrashort-acting benzodiazepine in which the lipid bond can be rapidly hydrolyzed by nonspecific lipases in the plasma. Therefore, remimazolam can be used for general anesthesia without intubation in patients undergoing short procedures. In this study, we compared the safety and efficacy of remimazolam with those of propofol for cold knife conization. Methods This single-center, randomized controlled trial screened 104 patients, and 90 were randomly assigned to receive propofol (P, N  = 45) or remimazolam (R, N  = 45) during cold knife conization. All the patients received a 1 µg/kg fentanyl injection. The patients received 1.5 mg/kg propofol or 0.2 mg/kg remimazolam injection, followed by a rate of 4 ~ 12 mg/kg/h or 1.0 ~ 3.0 mg/kg/h continuous intravenous infusion, respectively, to keep the patient state index (PSi) between 35 and 50. The primary outcome was intraoperative hypoxemia. The secondary outcomes were hemodynamic parameters, respiratory parameters, and other adverse events. Results The incidence of intraoperative hypoxemia in the R group was significantly lower than that in the P group (46.7% vs. 71.1%, p  = 0.018). Compared with patients in the P group, patients in the R group had fewer changes in the respiratory rate, mean arterial pressure and heart rate at some time points during surgery. The incidences of hypotension (15.6% vs. 35.6%, p  = 0.030) and injection pain (42.2% vs. 84.4%, p  < 0.001) were lower in the R group than in the P group; however, patients in the R group required more time to awaken (7.9 ± 4.5 min vs. 4.3 ± 1.7 min, p  < 0.001). Conclusion In conclusion, patients in the R group had a lower incidence of hypoxemia and fewer hemodynamic changes than did patients in the P group. Thus, remimazolam can be safely used for unintubated general anesthesia in patients undergoing cold knife conization. Trial registration The trial registration number is ChiCTR2200065519.

Background The aim of this study was to determine the effect of cerclage in women who underwent cervical conization. Methods Study data were collected from the Korea National Health Insurance Claims Database of the Health Insurance Review and Assessment Service for 2009–2013. Women who had a conization in 2009 and a subsequent first delivery between 2009 and 2013 in Korea were enrolled. Results Among the women who had conization in 2009, 1075 women had their first delivery between 2009 and 2013. A cerclage was placed in 161 of the women who were treated by conization. The rate of preterm birth was higher in the women who were treated with cerclage following a conization compared with those without cerclage (10.56 vs 4.27, p  < 0.01, respectively). The multivariate regression analysis revealed that the women who were treated cerclage following a conization had an increased risk of preterm delivery compared with women without cerclage (odds ratio (OR), 2.6, 95% confidence interval (CI), 1.4–4.9). Conclusion Our study showed that cerclage associated with an increased risk of preterm birth and preterm premature rupture of membranes in women who underwent conization. Further studies are required to clarify the mechanism by which cerclage affects the risk of preterm birth.

Background This study was conducted to identify the risk of residual or recurrent high‐grade squamous intraepithelial lesions or worse (HSIL+) in patients with successful conization and to develop a customized management strategy. Methods This retrospective study included 939 patients who underwent cold knife conization (CKC) for cervical intraepithelial neoplasia 3 at a hospital in China between January 1, 2013 and December 31, 2020. Demographic characteristics and test results were obtained before and 6, 12, and 24 months after CKC and annually thereafter. Human papillomavirus (HPV) persistence was defined as HPV positive at both 6 and 12 months after CKC, and the primary endpoint was residual or recurrent HSIL+ after CKC. Results The mean follow‐up period was 68.8 months. In total, 61 (6.5%) patients had HPV persistence, and 19 (2.0%) had residual or recurrent HSIL+. The risk of residual or recurrent HSIL+ was increased in patients with HPV infection at 6 months (hazard ratio [HR], 84.6; 95% confidence interval [CI], 11.2–641) and 12 months (HR, 214; 95% CI, 28.1–1625) after CKC, and HPV persistence after CKC (HR, 244; 95% CI, 32.2–1854). Comparing two different colposcopic referral criteria for HPV persistence and HPV positive 6 months post‐CKC, substantially fewer colposcopies were performed per case of residual or recurrent HSIL+ detected in patients with HPV persistence after CKC (3.39 vs. 8.28). Conclusions The risk of residual or recurrent HSIL+ was higher in patients with HPV persistence after CKC. In patients with negative margins, extending the follow‐up interval to 12 months may reduce the number of HPV tests and colposcopy referral rates while maintaining HSIL+ detection. This retrospective cohort study followed up women who underwent CKC and had negative margins on conization for up to 10 years. The risk of residual or recurrent HSIL+ was higher in patients with HPV persistence for 12 months compared with HPV positive at 6 months after CKC. In patients with negative margins, extending the follow‐up interval to 12 months may reduce the number of HPV tests and colposcopy referral rates while maintaining HSIL+ detection.