Tim Mathes, Barbara Prediger, Maren Walgenbach, Robert Siegel
{"title":"补片固定技术在原发性腹疝或切口疝修补中的应用。","authors":"Tim Mathes, Barbara Prediger, Maren Walgenbach, Robert Siegel","doi":"10.1002/14651858.CD011563.pub2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The use of a mesh in primary ventral or incisional hernia repair lowers the recurrence rate and is the accepted standard of care for larger defects. In laparoscopic primary ventral or incisional hernia repair the insertion of a mesh is indispensable. Different mesh fixation techniques have been used and refined over the years. The type of fixation technique is claimed to have a major impact on recurrence rates, chronic pain, health-related quality of life (HRQOL) and complication rates.</p><p><strong>Objectives: </strong>To determine the impact of different mesh fixation techniques for primary and incisional ventral hernia repair on hernia recurrence, chronic pain, HRQOL and complications.</p><p><strong>Search methods: </strong>On 2 October 2020 we searched CENTRAL, MEDLINE (Ovid MEDLINE(R)) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)), Ovid Embase, and two trials registries. We also performed handsearches, and contacted experts from the European Hernia Society (EHS).</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) including adults with primary ventral or incisional hernia that compared different types of mesh fixation techniques (absorbable/nonabsorbable sutures, absorbable/nonabsorbable tacks, fibrin glue, and combinations of these techniques).</p><p><strong>Data collection and analysis: </strong>We extracted data in standardised piloted tables, or if necessary, directly into Review Manager 5. We assessed risks of bias with the Cochrane 'Risk of bias' tool. Two review authors independently selected the publications, and extracted data on results. We calculated risk ratios (RRs) for binary outcomes and mean differences (MDs) for continuous outcomes. For pooling we used an inverse-variance random-effects meta-analysis or the Peto method in the case of rare events. We prepared GRADE 'Summary of findings' tables. For laparoscopic repair we considered absorbable tacks compared to nonabsorbable tacks, and nonabsorbable tacks compared to nonabsorbable sutures as key comparisons.</p><p><strong>Main results: </strong>We included 10 trials with a total of 787 participants. The number of randomised participants ranged from 40 to 199 per comparison. Eight studies included participants with both primary and incisional ventral hernia. One study included only participants with umbilical hernia, and another only participants with incisional hernia. Hernia size varied between studies. We judged the risk of bias as moderate to high. Absorbable tacks compared to nonabsorbable tacks Recurrence rates in the groups were similar (RR 0.74, 95% confidence interval (CI) 0.17 to 3.22; 2 studies, 101 participants). It is uncertain whether there is a difference between absorbable tacks and nonabsorbable tacks in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Nonabsorbable tacks compared to nonabsorbable sutures At six months there was one recurrence in each group (RR 1.00, 95% CI 0.07 to 14.79; 1 study, 36 participants). It is uncertain whether there is a difference between nonabsorbable tacks and nonabsorbable sutures in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up and chronic pain is negligible. We found no study that assessed HRQOL. Absorbable tacks compared to absorbable sutures No recurrence was observed at one year (very low certainty of evidence). Early postoperative pain was higher in the tacks group (VAS 0 - 10: MD -2.70, 95% CI -6.67 to 1.27; 1 study, 48 participants). It is uncertain whether there is a difference between absorbable tacks compared to absorbable sutures in early postoperative pain because the certainty of evidence was very low. The MD for late follow-up pain was -0.30 (95% CI -0.74 to 0.14; 1 study, 48 participants). We found no study that assessed HRQOL. Combination of different fixation types (tacks and sutures) or materials (absorbable and nonabsorbable) There were mostly negligible or only small differences between combinations (e.g. tacks plus sutures) compared to a single technique (e.g. sutures only), as well as combinations compared to other combinations (e.g. absorbable sutures combined with nonabsorbable sutures compared to absorbable tacks combined with nonabsorbable tacks) in all outcomes. It is uncertain whether there is an advantage for combining different fixation types or materials for recurrence, chronic pain, HRQOL and complications, because the evidence certainty was very low or low, or we found no study on important outcomes. Nonabsorbable tacks compared to fibrin sealant The two studies showed different directions of effects: one showed higher rates for nonabsorbable tacks, and the other showed higher rates for fibrin sealant. Low-certainty evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Absorbable tacks compared to fibrin sealant One recurrence in the tacks group and none in the fibrin sealant group were noted after one year (low certainty of evidence). Early postoperative pain might be slightly lower using tacks (VAS 0 - 100; MD -12.40, 95% CI -27.60 to, 2.80;1 study, 50 participants; low-certainty evidence). The pattern of pain and HRQOL course over time (up to 1 year) was similar in the groups (low certainty of evidence).</p><p><strong>Authors' conclusions: </strong>Currently none of the techniques can be considered superior to any other, because the certainty of evidence was low or very low for all outcomes.</p>","PeriodicalId":515753,"journal":{"name":"The Cochrane database of systematic reviews","volume":" ","pages":"CD011563"},"PeriodicalIF":0.0000,"publicationDate":"2021-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/14651858.CD011563.pub2","citationCount":"15","resultStr":"{\"title\":\"Mesh fixation techniques in primary ventral or incisional hernia repair.\",\"authors\":\"Tim Mathes, Barbara Prediger, Maren Walgenbach, Robert Siegel\",\"doi\":\"10.1002/14651858.CD011563.pub2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The use of a mesh in primary ventral or incisional hernia repair lowers the recurrence rate and is the accepted standard of care for larger defects. In laparoscopic primary ventral or incisional hernia repair the insertion of a mesh is indispensable. Different mesh fixation techniques have been used and refined over the years. The type of fixation technique is claimed to have a major impact on recurrence rates, chronic pain, health-related quality of life (HRQOL) and complication rates.</p><p><strong>Objectives: </strong>To determine the impact of different mesh fixation techniques for primary and incisional ventral hernia repair on hernia recurrence, chronic pain, HRQOL and complications.</p><p><strong>Search methods: </strong>On 2 October 2020 we searched CENTRAL, MEDLINE (Ovid MEDLINE(R)) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)), Ovid Embase, and two trials registries. We also performed handsearches, and contacted experts from the European Hernia Society (EHS).</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) including adults with primary ventral or incisional hernia that compared different types of mesh fixation techniques (absorbable/nonabsorbable sutures, absorbable/nonabsorbable tacks, fibrin glue, and combinations of these techniques).</p><p><strong>Data collection and analysis: </strong>We extracted data in standardised piloted tables, or if necessary, directly into Review Manager 5. We assessed risks of bias with the Cochrane 'Risk of bias' tool. Two review authors independently selected the publications, and extracted data on results. We calculated risk ratios (RRs) for binary outcomes and mean differences (MDs) for continuous outcomes. For pooling we used an inverse-variance random-effects meta-analysis or the Peto method in the case of rare events. We prepared GRADE 'Summary of findings' tables. For laparoscopic repair we considered absorbable tacks compared to nonabsorbable tacks, and nonabsorbable tacks compared to nonabsorbable sutures as key comparisons.</p><p><strong>Main results: </strong>We included 10 trials with a total of 787 participants. The number of randomised participants ranged from 40 to 199 per comparison. Eight studies included participants with both primary and incisional ventral hernia. One study included only participants with umbilical hernia, and another only participants with incisional hernia. Hernia size varied between studies. We judged the risk of bias as moderate to high. Absorbable tacks compared to nonabsorbable tacks Recurrence rates in the groups were similar (RR 0.74, 95% confidence interval (CI) 0.17 to 3.22; 2 studies, 101 participants). It is uncertain whether there is a difference between absorbable tacks and nonabsorbable tacks in recurrence because the certainty of evidence was very low. 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It is uncertain whether there is a difference between absorbable tacks compared to absorbable sutures in early postoperative pain because the certainty of evidence was very low. The MD for late follow-up pain was -0.30 (95% CI -0.74 to 0.14; 1 study, 48 participants). We found no study that assessed HRQOL. Combination of different fixation types (tacks and sutures) or materials (absorbable and nonabsorbable) There were mostly negligible or only small differences between combinations (e.g. tacks plus sutures) compared to a single technique (e.g. sutures only), as well as combinations compared to other combinations (e.g. absorbable sutures combined with nonabsorbable sutures compared to absorbable tacks combined with nonabsorbable tacks) in all outcomes. It is uncertain whether there is an advantage for combining different fixation types or materials for recurrence, chronic pain, HRQOL and complications, because the evidence certainty was very low or low, or we found no study on important outcomes. Nonabsorbable tacks compared to fibrin sealant The two studies showed different directions of effects: one showed higher rates for nonabsorbable tacks, and the other showed higher rates for fibrin sealant. Low-certainty evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Absorbable tacks compared to fibrin sealant One recurrence in the tacks group and none in the fibrin sealant group were noted after one year (low certainty of evidence). Early postoperative pain might be slightly lower using tacks (VAS 0 - 100; MD -12.40, 95% CI -27.60 to, 2.80;1 study, 50 participants; low-certainty evidence). 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引用次数: 15
摘要
背景:在腹疝或切口疝修补术中使用补片可降低复发率,是治疗较大缺损的公认标准。在腹腔镜原发性腹疝或切口疝修补中,补片的插入是必不可少的。不同的网片固定技术已经使用和改进了多年。据称,固定技术的类型对复发率、慢性疼痛、健康相关生活质量(HRQOL)和并发症发生率有重要影响。目的:探讨原发性和切口腹疝修补术中不同补片固定技术对疝复发、慢性疼痛、HRQOL及并发症的影响。检索方法:在2020年10月2日,我们检索了CENTRAL, MEDLINE(Ovid MEDLINE(R)) Epub Ahead of Print, In-Process & Other非索引引文,Ovid MEDLINE(R) Daily和Ovid MEDLINE(R)), Ovid Embase和两个试验注册中心。我们还进行了手查,并联系了欧洲疝气协会(EHS)的专家。选择标准:我们纳入了随机对照试验(RCTs),包括原发性腹疝或切口疝的成人,比较不同类型的网状固定技术(可吸收/不可吸收缝线、可吸收/不可吸收钉、纤维蛋白胶和这些技术的组合)。数据收集和分析:我们从标准化的试验表中提取数据,或者如果有必要,直接提取到Review Manager 5中。我们使用Cochrane“偏倚风险”工具评估偏倚风险。两位综述作者独立选择出版物,并提取结果数据。我们计算了二元结局的风险比(rr)和连续结局的平均差异(MDs)。对于合并,我们使用了反方差随机效应荟萃分析,或者在罕见事件的情况下使用Peto方法。我们准备了GRADE 'Summary of findings'表格。对于腹腔镜修复,我们将可吸收钉与不可吸收钉的比较,以及不可吸收钉与不可吸收缝线的比较作为关键的比较。主要结果:我们纳入了10项试验,共787名受试者。每次比较的随机参与者数量从40到199人不等。8项研究包括原发性和切口腹疝的参与者。一项研究仅包括脐疝患者,另一项研究仅包括切口疝患者。不同研究的疝大小不同。我们判断偏倚的风险为中等到高。两组患者的复发率相似(RR 0.74, 95%可信区间(CI) 0.17 ~ 3.22;2项研究,101名受试者)。由于证据的确定性非常低,因此不确定可吸收型和不可吸收型在复发方面是否存在差异。有证据表明,两组在术后早期、随访后期、慢性疼痛和HRQOL方面的差异可以忽略不计。6个月时,两组各有1例复发(RR 1.00, 95% CI 0.07 ~ 14.79;1项研究,36名参与者)。由于证据的确定性非常低,因此不确定不可吸收的针和不可吸收的缝合线在复发方面是否存在差异。有证据表明,两组在术后早期、后期随访和慢性疼痛方面的差异可以忽略不计。我们没有发现评估HRQOL的研究。可吸收缝合线与可吸收缝合线的比较一年内未观察到复发(证据的确定性非常低)。术后早期疼痛在治疗组较高(VAS 0 - 10: MD -2.70, 95% CI -6.67 ~ 1.27;1项研究,48名参与者)。由于证据的确定性非常低,因此尚不确定可吸收针与可吸收缝线在术后早期疼痛方面是否存在差异。晚期随访疼痛的MD为-0.30 (95% CI -0.74 ~ 0.14;1项研究,48名参与者)。我们没有发现评估HRQOL的研究。不同固定类型(钉和缝线)或材料(可吸收和不可吸收)的组合(如钉加缝线)与单一技术(如仅缝线)相比,以及与其他组合(如可吸收缝线与不可吸收缝线结合,可吸收缝线与不可吸收缝线结合,可吸收缝线与不可吸收缝线结合)相比,在所有结果中,组合之间的差异大多可以忽略不计或只有很小的差异。对于复发、慢性疼痛、HRQOL和并发症,不同固定类型或材料的组合是否有优势尚不确定,因为证据确定性很低或很低,或者我们没有发现重要结局的研究。两项研究显示了不同的效果方向:一项研究显示不可吸收性钉的发生率更高,另一项研究显示纤维蛋白密封剂的发生率更高。 低确定性证据表明,两组在术后早期、随访后期、慢性疼痛和HRQOL方面的差异可以忽略不计。可吸收钉与纤维蛋白密封剂对比一年后,钉组复发1例,纤维蛋白密封剂组无复发(证据确定性低)。术后早期疼痛可以稍低一些(VAS 0 - 100;MD -12.40, 95% CI -27.60 - 2.80;1项研究,50名受试者;确定性的证据)。两组疼痛模式和HRQOL病程(长达1年)相似(证据确定性低)。作者的结论:目前没有一种技术可以被认为优于其他技术,因为所有结果的证据确定性都很低或非常低。
Mesh fixation techniques in primary ventral or incisional hernia repair.
Background: The use of a mesh in primary ventral or incisional hernia repair lowers the recurrence rate and is the accepted standard of care for larger defects. In laparoscopic primary ventral or incisional hernia repair the insertion of a mesh is indispensable. Different mesh fixation techniques have been used and refined over the years. The type of fixation technique is claimed to have a major impact on recurrence rates, chronic pain, health-related quality of life (HRQOL) and complication rates.
Objectives: To determine the impact of different mesh fixation techniques for primary and incisional ventral hernia repair on hernia recurrence, chronic pain, HRQOL and complications.
Search methods: On 2 October 2020 we searched CENTRAL, MEDLINE (Ovid MEDLINE(R)) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)), Ovid Embase, and two trials registries. We also performed handsearches, and contacted experts from the European Hernia Society (EHS).
Selection criteria: We included randomised controlled trials (RCTs) including adults with primary ventral or incisional hernia that compared different types of mesh fixation techniques (absorbable/nonabsorbable sutures, absorbable/nonabsorbable tacks, fibrin glue, and combinations of these techniques).
Data collection and analysis: We extracted data in standardised piloted tables, or if necessary, directly into Review Manager 5. We assessed risks of bias with the Cochrane 'Risk of bias' tool. Two review authors independently selected the publications, and extracted data on results. We calculated risk ratios (RRs) for binary outcomes and mean differences (MDs) for continuous outcomes. For pooling we used an inverse-variance random-effects meta-analysis or the Peto method in the case of rare events. We prepared GRADE 'Summary of findings' tables. For laparoscopic repair we considered absorbable tacks compared to nonabsorbable tacks, and nonabsorbable tacks compared to nonabsorbable sutures as key comparisons.
Main results: We included 10 trials with a total of 787 participants. The number of randomised participants ranged from 40 to 199 per comparison. Eight studies included participants with both primary and incisional ventral hernia. One study included only participants with umbilical hernia, and another only participants with incisional hernia. Hernia size varied between studies. We judged the risk of bias as moderate to high. Absorbable tacks compared to nonabsorbable tacks Recurrence rates in the groups were similar (RR 0.74, 95% confidence interval (CI) 0.17 to 3.22; 2 studies, 101 participants). It is uncertain whether there is a difference between absorbable tacks and nonabsorbable tacks in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Nonabsorbable tacks compared to nonabsorbable sutures At six months there was one recurrence in each group (RR 1.00, 95% CI 0.07 to 14.79; 1 study, 36 participants). It is uncertain whether there is a difference between nonabsorbable tacks and nonabsorbable sutures in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up and chronic pain is negligible. We found no study that assessed HRQOL. Absorbable tacks compared to absorbable sutures No recurrence was observed at one year (very low certainty of evidence). Early postoperative pain was higher in the tacks group (VAS 0 - 10: MD -2.70, 95% CI -6.67 to 1.27; 1 study, 48 participants). It is uncertain whether there is a difference between absorbable tacks compared to absorbable sutures in early postoperative pain because the certainty of evidence was very low. The MD for late follow-up pain was -0.30 (95% CI -0.74 to 0.14; 1 study, 48 participants). We found no study that assessed HRQOL. Combination of different fixation types (tacks and sutures) or materials (absorbable and nonabsorbable) There were mostly negligible or only small differences between combinations (e.g. tacks plus sutures) compared to a single technique (e.g. sutures only), as well as combinations compared to other combinations (e.g. absorbable sutures combined with nonabsorbable sutures compared to absorbable tacks combined with nonabsorbable tacks) in all outcomes. It is uncertain whether there is an advantage for combining different fixation types or materials for recurrence, chronic pain, HRQOL and complications, because the evidence certainty was very low or low, or we found no study on important outcomes. Nonabsorbable tacks compared to fibrin sealant The two studies showed different directions of effects: one showed higher rates for nonabsorbable tacks, and the other showed higher rates for fibrin sealant. Low-certainty evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Absorbable tacks compared to fibrin sealant One recurrence in the tacks group and none in the fibrin sealant group were noted after one year (low certainty of evidence). Early postoperative pain might be slightly lower using tacks (VAS 0 - 100; MD -12.40, 95% CI -27.60 to, 2.80;1 study, 50 participants; low-certainty evidence). The pattern of pain and HRQOL course over time (up to 1 year) was similar in the groups (low certainty of evidence).
Authors' conclusions: Currently none of the techniques can be considered superior to any other, because the certainty of evidence was low or very low for all outcomes.