Tzelnick Sharon, Alkan Uri, Leshno Moshe, Hwang Peter, Soudry Ethan
Department of Otolaryngology - Head and Neck Surgery, Rabin Medical Center, Petah Tikva, Israel.
Cochrane Database Syst Rev. 2018 Nov 8;11(11):CD011988. doi: 10.1002/14651858.CD011988.pub2.
Endoscopic sinus surgery (ESS) is often recommended for symptomatic patients with recurrent acute or chronic rhinosinusitis who have failed conservative treatment. Postoperative care has been felt to be critical for both maintaining the surgical patency of the operated sinuses and improving patient symptoms. Debridement of the sinonasal cavities is one such postoperative care measure that has frequently been studied in the literature, often with conflicting conclusions.
To assess the effects of postoperative sinonasal debridement versus no debridement following endoscopic sinus surgery.
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); PubMed; EMBASE; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 21 May 2018.
Randomised controlled trials comparing postoperative nasal debridement versus no debridement in adult patients with recurrent acute or chronic rhinosinusitis undergoing endoscopic sinus surgery. We included studies in which the patients acted as self-controls (i.e. one side of the nose underwent debridement and the other side did not) only for the secondary endoscopy outcomes.
We used the standard methodological procedures expected by Cochrane. Our primary outcome measures were: health-related quality of life, disease severity (patient-reported symptom scores) and significant adverse effects (bleeding requiring intervention, severe pain, iatrogenic injury). Secondary outcomes were: postoperative endoscopic appearance of the sinonasal surgical cavities (endoscopic scores), recorded use of postoperative medical treatment and rate of revision surgery. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
We included four studies (152 participants), with a follow-up duration ranging from three months to 12 months. In two studies patients acted as self-controls, i.e. one side of the nose underwent debridement and the other side did not ('split-nose' studies). The risk of bias in all studies was high, mostly due to the inability to blind the patients to the debridement procedure.Primary outcomesDisease-specific health-related quality of life scoresOnly one study (58 participants) provided data for disease-specific health-related quality of life. At six months follow-up, lower disease-specific health-related quality of life scores, measured using the Sino-Nasal Outcome Test-22 (SNOT-22, range 0 to 110), were noted in the debridement group but the difference was not statistically significant (9.7 in the debridement group versus 10.3 in the control group, P = 0.47) (low-quality evidence).Disease severity (patient-reported symptom score)Only one study (60 participants) provided data for disease severity measured by visual analogue scale (VAS) score. No significant differences in total symptom score were observed between groups postoperatively (low-quality evidence).Significant adverse effectsSignificant adverse effects related to the debridement procedure were not reported in any of the included studies, however it is not clear whether data regarding adverse effects were not collected or if none were indeed observed in any of the included studies.Secondary outcomesAll four studies assessed thepostoperative endoscopic appearance of the sinonasal cavities using the Lund-Kennedy score (range 0 to 10). A pooled analysis of endoscopic scores in the two non 'split-nose' studies revealed better endoscopic scores in the debridement group, however this was not a statistically significant difference (mean difference -0.31, 95% confidence interval (CI) -1.35 to 0.72; I² = 0%; two studies; 118 participants) (low-quality evidence). A sub-analysis of the adhesion formation component of the endoscopic score was available for all four studies and revealed a significantly lower adhesion rate in the debridement group (risk ratio 0.43, 95% CI 0.28 to 0.68; I² = 29%; four studies; 152 participants). Analysis of the number needed to treat to benefit revealed that for every three patients undergoing debridement, the endoscopic score would be decreased by one point in one patient. For every five patients undergoing debridement adhesion formation would be prevented in one patient.Use of postoperative medical treatment was reported in all studies, all of which recommended nasal douching. Steroids (systemic or nasal) were administered in two studies. However, the data were very limited and heterogeneous, therefore we could not analyse the impact of concomitant postoperative medical treatment.The rate of revision surgery was not reported in any of the included studies, however it is not clear whether these data were not recorded or if there were no revision surgeries in any of the included studies.
AUTHORS' CONCLUSIONS: We are uncertain about the effects of postoperative sinonasal debridement due to high risk of bias in the included studies and the low quality of the evidence. Sinonasal debridement may make little or no difference to disease-specific health-related quality of life or disease severity. Low-quality evidence suggests that postoperative debridement is associated with a significantly lower risk of adhesions at three months follow-up. Whether this has any impact on longer-term outcomes is unknown.
对于经保守治疗无效的复发性急性或慢性鼻窦炎的有症状患者,常建议行鼻内镜鼻窦手术(ESS)。术后护理对于维持手术鼻窦的通畅及改善患者症状至关重要。鼻窦清创术是术后护理措施之一,在文献中常被研究,但结论往往相互矛盾。
评估鼻内镜鼻窦手术后鼻窦清创与不清创的效果。
Cochrane耳鼻喉信息专家检索了耳鼻喉试验注册库、对照试验中央注册库(CENTRAL,通过Cochrane研究注册库)、PubMed、EMBASE、科学引文索引、ClinicalTrials.gov、国际临床试验注册平台及其他已发表和未发表试验的来源。检索日期为2018年5月21日。
比较复发性急性或慢性鼻窦炎成年患者行鼻内镜鼻窦手术后鼻腔清创与不清创的随机对照试验。仅在次要内镜检查结果方面,我们纳入了患者作为自身对照的研究(即一侧鼻腔进行清创,另一侧不进行)。
我们采用了Cochrane预期的标准方法程序。我们的主要结局指标为:与健康相关的生活质量、疾病严重程度(患者报告的症状评分)和严重不良反应(需要干预的出血、严重疼痛、医源性损伤)。次要结局指标为:鼻窦手术腔的术后内镜表现(内镜评分)、术后药物治疗的记录使用情况及再次手术率。我们使用GRADE评估每个结局的证据质量;这在文中用斜体表示。
我们纳入了四项研究(152名参与者),随访时间为3个月至12个月。两项研究中患者作为自身对照,即一侧鼻腔进行清创,另一侧不进行(“分鼻”研究)。所有研究中的偏倚风险都很高,主要是因为无法让患者对清创程序不知情。
主要结局
疾病特异性健康相关生活质量评分
只有一项研究(58名参与者)提供了疾病特异性健康相关生活质量的数据。在6个月的随访中,清创组使用鼻窦结局测试-22(SNOT-22,范围为0至110)测量的疾病特异性健康相关生活质量评分较低,但差异无统计学意义(清创组为9.7,对照组为10.3,P = 0.47)(低质量证据)。
疾病严重程度(患者报告的症状评分)
只有一项研究(60名参与者)提供了用视觉模拟量表(VAS)评分测量疾病严重程度的数据。术后两组间总症状评分无显著差异(低质量证据)。
严重不良反应
纳入的任何研究均未报告与清创程序相关的严重不良反应,然而尚不清楚是未收集不良反应数据还是在纳入的任何研究中确实未观察到不良反应。
次要结局
所有四项研究均使用Lund-Kennedy评分(范围为0至10)评估鼻窦腔的术后内镜表现。两项非“分鼻”研究的内镜评分汇总分析显示,清创组的内镜评分较好,但差异无统计学意义(平均差异-0.31,95%置信区间(CI)-1.35至0.72;I² = 0%;两项研究;118名参与者)(低质量证据)。所有四项研究都有内镜评分中粘连形成部分的亚组分析,显示清创组的粘连率显著较低(风险比0.43,95%CI 0.28至0.68;I² = 29%;四项研究;152名参与者)。治疗获益所需人数分析显示,每三名接受清创的患者中,有一名患者的内镜评分将降低一分。每五名接受清创的患者中,有一名患者可预防粘连形成。
所有研究均报告了术后药物治疗的使用情况,所有研究均推荐鼻腔冲洗。两项研究中使用了类固醇(全身或鼻腔)。然而数据非常有限且异质性较大,因此我们无法分析术后联合药物治疗的影响。
纳入的任何研究均未报告再次手术率,然而尚不清楚是未记录这些数据还是在纳入的任何研究中均未进行再次手术。
由于纳入研究中的偏倚风险高且证据质量低,我们不确定术后鼻窦清创的效果。鼻窦清创对疾病特异性健康相关生活质量或疾病严重程度可能影响很小或无影响。低质量证据表明,术后清创与3个月随访时粘连风险显著降低相关。这对长期结局是否有任何影响尚不清楚。