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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.

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.

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.

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.

IntroductionAdenocarcinoma in situ (AIS) of the uterine cervix is the precursor to invasive endocervical adenocarcinoma. An excisional biopsy such as a cold knife cone biopsy (CKC) should be performed to exclude invasive adenocarcinoma. Loop electrosurgical excision procedure (LEEP) is an alternative modality to CKC but is controversial in AIS. There is a perception that there is a greater likelihood of incomplete excision of AIS with LEEP because the depth of excised tissue tends to be smaller and the tissue margins may show thermal artefact which can interfere with pathology assessment. In the USA, guidelines recommend that any treatment modality can be used to excise AIS, provided that the specimen remains intact with interpretable margins. However, there are no high-quality studies comparing LEEP with CKC and well-designed prospective studies are needed. If such a study were to show that LEEP was non-inferior to CKC for the outcomes of post-treatment persistence, recurrence and adenocarcinoma, LEEP could be recommended as an appropriate treatment option for AIS in selected patients. This would benefit women because, unlike CKC, LEEP does not require general anaesthesia and may be associated with reduced morbidity.Methods and analysisThe proposed exploratory study is a parallel group trial with an allocation ratio of 2:1 in favour of the intervention (LEEP: CKC). Participants are women aged ≥18 to ≤45 years diagnosed with AIS on cervical screening and/or colposcopically directed biopsy in Australia and New Zealand, who are to receive excisional treatment in a tertiary level centre.Ethics and disseminationEthical approval for the study has been granted by the St John of God Healthcare Human Research Ethics Committee (reference number #1137). Results from the study will be presented at conferences and published in a peer-reviewed scientific journal.RegistrationANZCTR registration number ACTRN12617000132347 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372173&isReview=true

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.

Aims: The objective of the current study was to evaluate the efficacy and feasibility of fibrin sealant (Tisseel®) in the loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN 2 or 3). Methods: We designed a single-blind, prospective, randomized study in 40 consecutive women undergoing LEEP for CIN 2 or 3 at our institute. Two milliliters of fibrin sealant (Tisseel) was applied to the uterine cervix of 20 women immediately after LEEP surgery (treatment group). We evaluated abdominal pain, vaginal bleeding, vaginal discharge and impairment in daily living after 1 week using visual analogue scale questionnaires and compared the results with those of 20 women who did not receive fibrin sealant (control group). Results: Among 40 women who returned for a follow-up 1 week after LEEP, 25 women (62.5%) reported at least one moderate to severe postprocedural symptom. The mean duration of moderate to severe vaginal bleeding and impairment in daily living during postoperative week 1 for the treatment group and the control group was 0.3 ± 0.80 versus 1.7 ± 2.36 days (p = 0.015) and 0.9 ± 1.37 versus 3.00 ± 2.62 days (p = 0.060), respectively. Conclusion: Intraoperative application of fibrin sealant (Tisseel) in LEEP can decrease postoperative vaginal bleeding and impairment in daily living.

Objective To assess the effect of treatment for cervical intraepithelial neoplasia (CIN) on obstetric outcomes and to correlate this with cone depth and comparison group used.Design Systematic review and meta-analysis.Data sources CENTRAL, Medline, Embase from 1948 to April 2016 were searched for studies assessing obstetric outcomes in women with or without previous local cervical treatment.Data extraction and synthesis Independent reviewers extracted the data and performed quality assessment using the Newcastle-Ottawa criteria. Studies were classified according to method and obstetric endpoint. Pooled risk ratios were calculated with a random effect model and inverse variance. Heterogeneity between studies was assessed with I2 statistics.Main outcome measures Obstetric outcomes comprised preterm birth (including spontaneous and threatened), premature rupture of the membranes, chorioamnionitis, mode of delivery, length of labour, induction of delivery, oxytocin use, haemorrhage, analgesia, cervical cerclage, and cervical stenosis. Neonatal outcomes comprised low birth weight, admission to neonatal intensive care, stillbirth, APGAR scores, and perinatal mortality.Results 71 studies were included (6 338 982 participants: 65 082 treated/6 292 563 untreated). Treatment significantly increased the risk of overall (<37 weeks; 10.7% v 5.4%; relative risk 1.78, 95% confidence interval 1.60 to 1.98), severe (<32-34 weeks; 3.5% v 1.4%; 2.40, 1.92 to 2.99), and extreme (<28-30 weeks; 1.0% v 0.3%; 2.54, 1.77 to 3.63) preterm birth. Techniques removing or ablating more tissue were associated with worse outcomes. Relative risks for delivery at <37 weeks were 2.70 (2.14 to 3.40) for cold knife conisation, 2.11 (1.26 to 3.54) for laser conisation, 2.02 (1.60 to 2.55) for excision not otherwise specified, 1.56 (1.36 to 1.79) for large loop excision of the transformation zone, and 1.46 (1.27 to 1.66) for ablation not otherwise specified. Compared with no treatment, the risk of preterm birth was higher in women who had undergone more than one treatment (13.2% v 4.1%; 3.78, 2.65 to 5.39) and with increasing cone depth (≤10-12 mm; 7.1% v 3.4%; 1.54, 1.09 to 2.18; ≥10-12 mm: 9.8% v 3.4%, 1.93, 1.62 to 2.31; ≥15-17 mm: 10.1% v 3.4%; 2.77, 1.95 to 3.93; ≥20 mm: 10.2% v 3.4%; 4.91, 2.06 to 11.68). The choice of comparison group affected the magnitude of effect. This was higher for external comparators, followed by internal comparators, and ultimately women with disease who did not undergo treatment. In women with untreated CIN and in pregnancies before treatment, the risk of preterm birth was higher than the risk in the general population (5.9% v 5.6%; 1.24, 1.14 to 1.35). Spontaneous preterm birth, premature rupture of the membranes, chorioamnionitis, low birth weight, admission to neonatal intensive care, and perinatal mortality were also significantly increased after treatment.Conclusions Women with CIN have a higher baseline risk for prematurity. Excisional and ablative treatment further increases that risk. The frequency and severity of adverse sequelae increases with increasing cone depth and is higher for excision than for ablation.

ObjectiveTo compare large loop excision of the transformation zone (LLETZ) with contour-loop excision of the transformation zone (C-LETZ) in management of cervical intraepithelial neoplasia (CIN) with respect to number of specimens obtained, weight of specimen, surgical margin, treatment time, and morbidity associated with those procedures.MethodWomen were randomly allocated to receive LLETZ or C-LETZ. Inclusion criteria were the following circumstances: (1) presence of biopsy-proved CIN 2/3, (2) persistent biopsy-proved CIN 1, (3) discrepancy between cytology and histology, or 4) an endocervical curettage was positive.ResultsNinety-eight women were eligible for the study. Mean weight of specimens in C-LETZ group was significantly more than LLETZ group (4.35 ± 1.39 vs. 3.55 ± 1.48 g, p = 0.007). Duration of treatment were similar in both groups (p = 0.39). After multiple logistic regressions were analyzed, C-LETZ was more likely to result in a single pathologic specimen (76 vs. 29.16 %, p < 0.001; adjusted RR 8.33, CI 3.23–21.47). There was no statistical significant difference in the frequency of positive margins between the groups (40 vs. 39.5 %, p = 0.64; adjusted RR 1.27, CI 0.46–3.50). The morbidity associated with those procedures was not different between the two groups.ConclusionC-LETZ has a clear clinical benefit in term of a higher rate of a single pathologic specimen. It removes more cervical tissue than LLETZ. The incidence of incomplete excision and complication seem to be similar in both groups.