Kietpeerakool Chumnan, Aue-Aungkul Apiwat, Galaal Khadra, Ngamjarus Chetta, Lumbiganon Pisake
Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, 123 Mitraparb Road, Amphur Muang, Khon Kaen, Thailand, 40002.
Cochrane Database Syst Rev. 2019 Feb 12;2(2):CD012828. doi: 10.1002/14651858.CD012828.pub2.
Radical hysterectomy is one of the standard treatments for stage Ia2 to IIa cervical cancer. Bladder dysfunction caused by disruption of the pelvic autonomic nerves is a common complication following standard radical hysterectomy and can affect quality of life significantly. Nerve-sparing radical hysterectomy is a modified radical hysterectomy, developed to permit resection of oncologically relevant tissues surrounding the cervical lesion, while preserving the pelvic autonomic nerves.
To evaluate the benefits and harms of nerve-sparing radical hysterectomy in women with stage Ia2 to IIa cervical cancer.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid (1946 to May week 2, 2018), and Embase via Ovid (1980 to 2018, week 21). We also checked registers of clinical trials, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies.
We included randomised controlled trials (RCTs) evaluating the efficacy and safety of nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa).
We applied standard Cochrane methodology for data collection and analysis. Two review authors independently selected potentially relevant RCTs, extracted data, evaluated risk of bias of the included studies, compared results and resolved disagreements by discussion or consultation with a third review author, and assessed the certainty of evidence.
We identified 1332 records as a result of the search (excluding duplicates). Of the 26 studies that potentially met the review criteria, we included four studies involving 205 women; most of the trials had unclear risks of bias. We identified one ongoing trial.The analysis of overall survival was not feasible, as there were no deaths reported among women allocated to standard radical hysterectomy. However, there were two deaths in among women allocated to the nerve-sparing technique. None of the included studies reported rates of intermittent self-catheterisation over one month following surgery. We could not analyse the relative effect of the two surgical techniques on quality of life due to inconsistent data reported. Nerve-sparing radical hysterectomy reduced postoperative bladder dysfunctions in terms of a shorter time to postvoid residual volume of urine ≤ 50 mL (mean difference (MD) -13.21 days; 95% confidence interval (CI) -24.02 to -2.41; 111 women; 2 studies; low-certainty evidence) and lower volume of postvoid residual urine measured one month following operation (MD -9.59 days; 95% CI -16.28 to -2.90; 58 women; 2 study; low-certainty evidence). There were no clear differences in terms of perioperative complications (RR 0.55; 95% CI 0.24 to 1.26; 180 women; 3 studies; low-certainty evidence) and disease-free survival (HR 0.63; 95% CI 0.00 to 106.95; 86 women; one study; very low-certainty evidence) between the comparison groups.
AUTHORS' CONCLUSIONS: Nerve-sparing radical hysterectomy may lessen the risk of postoperative bladder dysfunction compared to the standard technique, but the certainty of this evidence is low. The very low-certainty evidence for disease-free survival and lack of information for overall survival indicate that the oncological safety of nerve-sparing radical hysterectomy for women with early stage cervical cancer remains unclear. Further large, high-quality RCTs are required to determine, if clinically meaningful differences of survival exist between these two surgical treatments.
根治性子宫切除术是Ia2期至IIa期宫颈癌的标准治疗方法之一。盆腔自主神经损伤导致的膀胱功能障碍是标准根治性子宫切除术后常见的并发症,会显著影响生活质量。保留神经的根治性子宫切除术是一种改良的根治性子宫切除术,旨在切除宫颈病变周围的肿瘤相关组织,同时保留盆腔自主神经。
评估保留神经的根治性子宫切除术对Ia2期至IIa期宫颈癌女性的益处和危害。
我们检索了Cochrane对照试验中心注册库(CENTRAL;2018年第4期)、通过Ovid检索的MEDLINE(1946年至2018年5月第2周)以及通过Ovid检索的Embase(1980年至2018年第21周)。我们还查阅了临床试验注册库、灰色文献、会议报告、纳入研究的参考文献列表以及关键教科书,以寻找潜在的相关研究。
我们纳入了评估保留神经的根治性子宫切除术与标准根治性子宫切除术相比,对早期宫颈癌(Ia2期至IIa期)女性疗效和安全性的随机对照试验(RCT)。
我们采用Cochrane标准方法进行数据收集和分析。两位综述作者独立选择潜在相关的RCT,提取数据,评估纳入研究的偏倚风险,比较结果,并通过讨论或咨询第三位综述作者解决分歧,同时评估证据的确定性。
检索共识别出1332条记录(不包括重复记录)。在26项可能符合综述标准的研究中,我们纳入了4项涉及205名女性的研究;大多数试验的偏倚风险不明确。我们识别出一项正在进行的试验。由于分配到标准根治性子宫切除术组的女性中未报告死亡病例,因此无法进行总生存分析。然而,分配到保留神经技术组的女性中有2例死亡。纳入研究中均未报告术后一个月内间歇性自我导尿的发生率。由于报告的数据不一致,我们无法分析两种手术技术对生活质量的相对影响。保留神经的根治性子宫切除术在术后残余尿量≤50 mL的时间缩短方面(平均差(MD)-13.21天;95%置信区间(CI)-24.02至-2.41;111名女性;2项研究;低确定性证据)以及术后一个月测量的残余尿量降低方面(MD -9.59天;95%CI -16.28至-2.90;58名女性;2项研究;低确定性证据)降低了术后膀胱功能障碍的风险。两组在围手术期并发症(风险比(RR)0.55;95%CI 0.24至1.26;180名女性;3项研究;低确定性证据)和无病生存(风险比(HR)0.63;95%CI 0.00至106.95;86名女性;1项研究;极低确定性证据)方面没有明显差异。
与标准技术相比,保留神经的根治性子宫切除术可能会降低术后膀胱功能障碍的风险,但该证据的确定性较低。无病生存的极低确定性证据以及总生存信息的缺乏表明,保留神经的根治性子宫切除术对早期宫颈癌女性的肿瘤学安全性仍不明确。需要进一步开展大型、高质量的RCT来确定这两种手术治疗在生存方面是否存在具有临床意义的差异。