Pynnonen Melissa, Brinkmeier Jennifer V, Thorne Marc C, Chong Lee Yee, Burton Martin J
Department of Otolaryngology - Head and Neck Surgery, Taubman Center, 1500 E Medical Center Drive, Ann Arbor, Michigan, USA.
Cochrane Database Syst Rev. 2017 Aug 22;8(8):CD004619. doi: 10.1002/14651858.CD004619.pub3.
Tonsillectomy is a very common operation and is performed using various surgical methods. Coblation is a popular method because it purportedly causes less pain than other surgical methods. However, the superiority of coblation is unproven.
To compare the effects of coblation tonsillectomy for chronic tonsillitis or tonsillar hypertrophy with other surgical techniques, both hot and cold, on intraoperative morbidity, postoperative morbidity and procedural cost.
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2017, Issue 3); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 20 April 2017.
Randomised controlled trials (RCTs) of children and adults undergoing tonsillectomy with coblation compared with any other surgical technique. This review is limited to trials of extracapsular (traditional) tonsillectomy and excludes trials of intracapsular tonsil removal (tonsillotomy).
We used the standard Cochrane methods. Our primary outcomes were: patient-reported pain using a validated pain scale at postoperative days 1, 3 and 7; intraoperative blood loss; primary postoperative bleeding (within 24 hours) and secondary postoperative bleeding (more than 24 hours after surgery). Secondary outcomes were: time until resumption of normal diet, time until resumption of normal activity, duration of surgery and adverse effects including blood transfusion and the need for reoperation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
We included 29 studies, with a total of 2561 participants. All studies had moderate or high risk of bias. Sixteen studies used an adequate randomisation technique, however the inability to mask the surgical teams and/or provide adequate methods to mitigate the risk of bias put nearly all studies at moderate or high risk of detection and measurement bias for intraoperative blood loss, and primary and secondary bleeding. In contrast most studies (20) were at low risk of bias for pain assessment. Most studies did not report data in a manner permitting meta-analysis.Most studies did not clearly report the participant characteristics, surgical indications or whether patients underwent tonsillectomy or adenotonsillectomy. Most studies reported that tonsillitis (infection) and/or tonsillar hypertrophy (obstruction) were the indication for surgery. Seven studies included only adults, 16 studies included only children and six studies included both. Pain At postoperative day 1 there is very low quality evidence that patients in the coblation group had less pain, with a standardised mean difference (SMD) of -0.79 (95% confidence interval (CI) -1.38 to -0.19; 538 participants; six studies). This effect is reduced a SMD of -0.44 (95% CI -0.97 to 0.09; 401 participants; five studies; very low-quality evidence) at day 3, and at day 7 there is low quality evidence of little or no difference in pain (SMD -0.01, 95% CI -0.22 to 0.19; 420 participants; five studies). Although this suggests that pain may be slightly less in the coblation group between days 1 and 3, the clinical significance is unclear. Intraoperative blood loss Methodological differences between studies in the measurement of intraoperative blood loss precluded meta-analysis. Primary and secondary bleeding The risk of primary bleeding was similar (risk ratio (RR) 0.99, 95% CI 0.48 to 2.05; 2055 participants; 25 studies; low-quality evidence). The risk of secondary bleeding was greater in the coblation group with a risk ratio of 1.36 (95% CI 0.95 to 1.95; 2118 participants; 25 studies; low-quality evidence). Using the median of the control group as the baseline risk, the absolute risk in the coblation group was 5% versus 3.6% in the control group. The difference of 1.3% has a 95% CI of 0.2% lower in the coblation group to 3.5% higher. Secondary outcomes Differences in study design and data reporting precluded the identification of differences in the time to resumption of normal diet or activity, or whether there was a difference in the duration of surgery.Although we could not feasibly compare the costs of equipment or operative facility, anaesthetic and surgical fees across different healthcare systems we used duration of surgery as a proxy for cost. Although this outcome was commonly reported in studies, it was not possible to pool the data to determine whether there was a difference.Adverse events other than bleeding were not well reported. It is unclear whether there is a difference in postoperative infections or the need for reoperation.
AUTHORS' CONCLUSIONS: The coblation technique may cause less pain on postoperative day 1, but the difference is small and may be clinically meaningless. By postoperative day 3, the difference decreases further and by postoperative day 7 there appears to be little or no difference. We found similar rates of primary bleeding but we cannot rule out a small increased risk of secondary bleeding with coblation. The evidence supporting these findings is of low or very low quality, i.e. there is a very high degree of uncertainty about the results. Moreover, for most outcomes data were only available from a few of the 29 included studies.The current evidence is of very low quality, therefore it is uncertain whether or not the coblation technique has any advantages over traditional tonsillectomy techniques. Despite the large number of studies, failure to use standardised or validated outcome measures precludes the ability to pool data across studies. Therefore, well-conducted RCTs using consistent, validated outcome measures are needed to establish whether the coblation technique has a benefit over other methods. In the included studies we identified no clear difference in adverse events. However, given the rarity of these events, randomised trials lack the power to detect a difference. Data from large-scale registries will provide a better estimate of any difference in these rare outcomes.
扁桃体切除术是一种非常常见的手术,可采用多种手术方法进行。低温等离子消融术是一种常用的方法,因为据称它比其他手术方法引起的疼痛更少。然而,低温等离子消融术的优越性尚未得到证实。
比较低温等离子消融扁桃体切除术与其他手术技术(包括热刀和冷刀技术)治疗慢性扁桃体炎或扁桃体肥大时,在术中发病率、术后发病率和手术费用方面的效果。
Cochrane耳鼻喉科信息专家检索了耳鼻喉科试验注册库;Cochrane对照试验中心注册库(CENTRAL 2017年第3期);PubMed;Ovid Embase;CINAHL;Web of Science;ClinicalTrials.gov;ICTRP以及其他已发表和未发表试验的来源。检索日期为2017年4月20日。
将接受低温等离子消融扁桃体切除术的儿童和成人与任何其他手术技术进行比较的随机对照试验(RCT)。本综述仅限于囊外(传统)扁桃体切除术的试验,不包括囊内扁桃体切除术(扁桃体切开术)的试验。
我们采用了标准的Cochrane方法。我们的主要结局指标为:术后第1、3和7天使用经过验证的疼痛量表由患者报告的疼痛;术中失血;术后原发性出血(24小时内)和继发性出血(手术后24小时以上)。次要结局指标为:恢复正常饮食的时间、恢复正常活动的时间、手术持续时间以及包括输血和再次手术需求在内的不良反应。我们使用GRADE来评估每个结局指标的证据质量;这在文中以斜体表示。
我们纳入了29项研究,共2561名参与者。所有研究均存在中度或高度偏倚风险。16项研究采用了适当的随机化技术,然而,由于无法对手术团队进行盲法处理和/或提供足够的方法来降低偏倚风险,几乎所有研究在术中失血、原发性和继发性出血的检测和测量偏倚方面都处于中度或高度风险。相比之下,大多数研究(20项)在疼痛评估方面的偏倚风险较低。大多数研究未以允许进行荟萃分析的方式报告数据。大多数研究未明确报告参与者特征、手术指征或患者是否接受扁桃体切除术或腺样体扁桃体切除术。大多数研究报告扁桃体炎(感染)和/或扁桃体肥大(阻塞)为手术指征。7项研究仅纳入成人,16项研究仅纳入儿童,6项研究两者均有纳入。疼痛:在术后第1天,有极低质量的证据表明低温等离子消融术组患者的疼痛较轻,标准化均数差(SMD)为-0.79(95%置信区间(CI)-1.38至-0.19;538名参与者;6项研究)。在第3天,这种效果有所降低,SMD为-0.44(95%CI -0.97至0.09;401名参与者;5项研究;极低质量证据),在第7天,有低质量证据表明疼痛几乎没有差异(SMD -0.01,95%CI -0.22至0.19;420名参与者;5项研究)。虽然这表明低温等离子消融术组在第1天至第3天之间疼痛可能略轻,但临床意义尚不清楚。术中失血:各研究在术中失血测量方法上的差异使得无法进行荟萃分析。原发性和继发性出血:原发性出血风险相似(风险比(RR)0.99,95%CI 0.48至2.05;2055名参与者;25项研究;低质量证据)。低温等离子消融术组继发性出血风险更高,风险比为1.36(95%CI 0.95至1.95;2118名参与者;25项研究;低质量证据)。以对照组的中位数作为基线风险,低温等离子消融术组的绝对风险为5%,而对照组为3.6%。1.3%的差异有95%CI,低温等离子消融术组低0.2%至高3.5%。次要结局:研究设计和数据报告的差异使得无法确定恢复正常饮食或活动的时间是否存在差异以及手术持续时间是否存在差异。虽然我们无法切实比较不同医疗系统中设备、手术设施、麻醉和手术费用,但我们将手术持续时间作为成本的替代指标。尽管该结局指标在研究中普遍报告,但无法汇总数据以确定是否存在差异。除出血外的不良事件报告不充分。不清楚术后感染或再次手术需求是否存在差异。
低温等离子消融术可能在术后第1天引起的疼痛较少,但差异较小且可能无临床意义。到术后第3天,差异进一步减小,到术后第7天,似乎几乎没有差异。我们发现原发性出血发生率相似,但不能排除低温等离子消融术导致继发性出血风险略有增加。支持这些发现的证据质量低或极低,即结果存在非常高的不确定性。此外,对于大多数结局指标,仅有29项纳入研究中的少数几项提供了数据。当前证据质量极低,因此不确定低温等离子消融术是否比传统扁桃体切除术技术具有任何优势。尽管研究数量众多,但未能使用标准化或经过验证的结局指标妨碍了跨研究汇总数据的能力。因此,需要开展采用一致、经过验证的结局指标的高质量RCT,以确定低温等离子消融术是否比其他方法更具优势。在纳入的研究中,我们未发现不良事件存在明显差异。然而,鉴于这些事件罕见,随机试验缺乏检测差异的能力。来自大规模登记处的数据将能更好地估计这些罕见结局中的任何差异。