Athanasiou Antonios, Veroniki Areti Angeliki, Efthimiou Orestis, Kalliala Ilkka, Naci Huseyin, Bowden Sarah, Paraskevaidi Maria, Martin-Hirsch Pierre, Bennett Philip, Paraskevaidis Evangelos, Salanti Georgia, Kyrgiou Maria
Department of Surgery and Cancer, Faculty of Medicine, Institute of Reproductive and Developmental Biology, Imperial College London, London, UK.
Imperial College Healthcare NHS Trust, London, UK.
BMJ Open. 2019 Aug 2;9(8):e028008. doi: 10.1136/bmjopen-2018-028008.
Local treatments for cervical intraepithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the abnormal cells. A trend toward less radical techniques has raised concerns that this may adversely impact the rates of precancerous and cancerous recurrence. However, there has been no strong evidence to support such claims. We hereby describe a protocol of a systematic review and network meta-analysis that will update the evidence and compare all relevant treatments in terms of efficacy and complications.
Literature searches in electronic databases (CENTRAL, MEDLINE, EMBASE) or trial registries will identify published and unpublished randomised controlled trials (RCTs) and cohort studies comparing the efficacy and complications among different excisional and ablative techniques. The excisional techniques include cold knife, laser or Fischer cone, large loop or needle excision of the transformation zone and the ablative radical point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will be residual/recurrent disease defined as abnormal histology or cytology of any grade, while secondary outcomes will include treatment failure rates defined as high-grade histology or cytology, histologically confirmed CIN1+ or histologically confirmed CIN2+, human papillomavirus positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess the risk of bias in RCTs and observational studies using tools developed by the Cochrane Collaboration. Two authors will independently assess study eligibility, abstract the data and assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be conducted using the OR for dichotomous outcomes and the mean difference for continuous outcomes. The quality of the evidence for the primary outcome will be assessed using the CINeMA (Confidence In Network Meta-Analysis) tool.
Ethical approval is not required. We will disseminate findings to clinicians, policy-makers, patients and the public.
CRD42018115508.
宫颈上皮内瘤变（CIN）和微浸润性疾病的局部治疗会切除或消融子宫颈包含异常细胞的锥形部分。治疗技术趋于保守的趋势引发了人们对这可能对癌前病变和癌症复发率产生不利影响的担忧。然而，尚无有力证据支持此类说法。我们在此描述一项系统评价和网状Meta分析方案，该方案将更新证据，并在疗效和并发症方面比较所有相关治疗方法。
在电子数据库（CENTRAL、MEDLINE、EMBASE）或试验注册库中进行文献检索，以识别已发表和未发表的随机对照试验（RCT）以及队列研究，这些研究比较了不同切除和消融技术的疗效和并发症。切除技术包括冷刀、激光或费舍尔锥形切除术、转化区大环形或针形切除术，消融技术包括根治性点状透热疗法、冷冻疗法、冷凝或激光消融。主要结局将是定义为任何级别的异常组织学或细胞学的残留/复发性疾病，次要结局将包括定义为高级别组织学或细胞学、组织学确诊的CIN1+或组织学确诊的CIN2+的治疗失败率、人乳头瘤病毒阳性率、切缘累及率、出血率和宫颈狭窄率。我们将使用Cochrane协作网开发的工具评估RCT和观察性研究中的偏倚风险。两位作者将独立评估研究的纳入资格、提取数据并评估偏倚风险。将使用二分结局的OR和连续结局的平均差进行随机效应Meta分析和网状Meta分析。将使用CINeMA（网状Meta分析可信度）工具评估主要结局证据的质量。
无需伦理批准。我们将把研究结果传播给临床医生、政策制定者、患者和公众。
PROSPERO注册号：CRD42018115508。
